Pancreas and Biliary Tract

The number of U.S. emergency department visits for acute pancreatitis associated with alcohol abuse, chronic pancreatitis history, and younger age was on the rise in recent years, an analysis of a nationally representative database has suggested.

Katarzyna Bialasiewicz/Thinkstock

Help your patients better understand pancreatitis and available tests and treatments by using AGA patient education materials, https://www.gastro.org/practice-guidance/gi-patient-center/topic/pancreatitis.

SOURCE: Garg SK et al. J Clin Gastroenterol. 2018 Apr 6. doi: 10.1097/MCG.0000000000001030.

The number of U.S. emergency department visits for acute pancreatitis associated with alcohol abuse, chronic pancreatitis history, and younger age was on the rise in recent years, an analysis of a nationally representative database has suggested.

Katarzyna Bialasiewicz/Thinkstock

Help your patients better understand pancreatitis and available tests and treatments by using AGA patient education materials, https://www.gastro.org/practice-guidance/gi-patient-center/topic/pancreatitis.

SOURCE: Garg SK et al. J Clin Gastroenterol. 2018 Apr 6. doi: 10.1097/MCG.0000000000001030.

The number of U.S. emergency department visits for acute pancreatitis associated with alcohol abuse, chronic pancreatitis history, and younger age was on the rise in recent years, an analysis of a nationally representative database has suggested.

Katarzyna Bialasiewicz/Thinkstock

Help your patients better understand pancreatitis and available tests and treatments by using AGA patient education materials, https://www.gastro.org/practice-guidance/gi-patient-center/topic/pancreatitis.

SOURCE: Garg SK et al. J Clin Gastroenterol. 2018 Apr 6. doi: 10.1097/MCG.0000000000001030.

Patients with acute pancreatitis should receive “goal-directed” fluid therapy with normal saline or Ringer’s lactate solution rather than hydroxyethyl starch (HES) fluids, states a new guideline from the AGA Institute.

In a single-center randomized trial, hydroxyethyl starch fluids conferred a 3.9-fold increase in the odds of multiorgan failure (95% confidence interval for odds ratio, 1.2-12.0) compared with normal saline in patients with acute pancreatitis, wrote guideline authors Seth D. Crockett, MD, MPH, of the University of North Carolina, Chapel Hill, and his associates. This trial and another randomized study found no mortality benefit for HES compared with fluid resuscitation. The evidence is “very low quality” but mirrors the critical care literature, according to the experts. So far, Ringer’s lactate solution and normal saline have shown similar effects on the risk of organ failure, necrosis, and mortality, but ongoing trials should better clarify this choice, they noted (Gastroenterology. doi: 10.1053/j.gastro.2018.01.032).

The guideline addresses the initial 2-week period of treating acute pancreatitis. It defines goal-directed fluid therapy as titration based on meaningful targets, such as heart rate, mean arterial pressure, central venous pressure, urine output, blood urea nitrogen concentration, and hematocrit. Studies of goal-directed fluid therapy in acute pancreatitis have been unblinded, have used inconsistent outcome measures, and have found no definite benefits over nontargeted fluid therapy, note the guideline authors. Nevertheless, they conditionally recommend goal-directed fluid therapy, partly because a randomized, blinded trial of patients with severe sepsis or septic shock (which physiologically resembles acute pancreatitis) had in-hospital mortality rates of 31% when they received goal-directed fluid therapy and 47% when they received standard fluid therapy (P = .0009).

The guideline recommends against routine use of two interventions: prophylactic antibiotics and urgent endoscopic retrograde cholangiopancreatography (ERCP) for patients with acute pancreatitis. The authors note that no evidence supports routine prophylactic antibiotics for acute pancreatitis patients without cholangitis, and that urgent ERCP did not significantly affect the risk of mortality, multiorgan failure, single-organ failure, infected pancreatic and peripancreatic necrosis, or necrotizing pancreatitis in eight randomized controlled trials of patients with acute gallstone pancreatitis.

Source: Crockett SD et al. Gastroenterology. doi: 10.1053/j.gastro.2018.01.032.

Patients with acute pancreatitis should receive “goal-directed” fluid therapy with normal saline or Ringer’s lactate solution rather than hydroxyethyl starch (HES) fluids, states a new guideline from the AGA Institute.

In a single-center randomized trial, hydroxyethyl starch fluids conferred a 3.9-fold increase in the odds of multiorgan failure (95% confidence interval for odds ratio, 1.2-12.0) compared with normal saline in patients with acute pancreatitis, wrote guideline authors Seth D. Crockett, MD, MPH, of the University of North Carolina, Chapel Hill, and his associates. This trial and another randomized study found no mortality benefit for HES compared with fluid resuscitation. The evidence is “very low quality” but mirrors the critical care literature, according to the experts. So far, Ringer’s lactate solution and normal saline have shown similar effects on the risk of organ failure, necrosis, and mortality, but ongoing trials should better clarify this choice, they noted (Gastroenterology. doi: 10.1053/j.gastro.2018.01.032).

The guideline addresses the initial 2-week period of treating acute pancreatitis. It defines goal-directed fluid therapy as titration based on meaningful targets, such as heart rate, mean arterial pressure, central venous pressure, urine output, blood urea nitrogen concentration, and hematocrit. Studies of goal-directed fluid therapy in acute pancreatitis have been unblinded, have used inconsistent outcome measures, and have found no definite benefits over nontargeted fluid therapy, note the guideline authors. Nevertheless, they conditionally recommend goal-directed fluid therapy, partly because a randomized, blinded trial of patients with severe sepsis or septic shock (which physiologically resembles acute pancreatitis) had in-hospital mortality rates of 31% when they received goal-directed fluid therapy and 47% when they received standard fluid therapy (P = .0009).

The guideline recommends against routine use of two interventions: prophylactic antibiotics and urgent endoscopic retrograde cholangiopancreatography (ERCP) for patients with acute pancreatitis. The authors note that no evidence supports routine prophylactic antibiotics for acute pancreatitis patients without cholangitis, and that urgent ERCP did not significantly affect the risk of mortality, multiorgan failure, single-organ failure, infected pancreatic and peripancreatic necrosis, or necrotizing pancreatitis in eight randomized controlled trials of patients with acute gallstone pancreatitis.

Source: Crockett SD et al. Gastroenterology. doi: 10.1053/j.gastro.2018.01.032.

Patients with acute pancreatitis should receive “goal-directed” fluid therapy with normal saline or Ringer’s lactate solution rather than hydroxyethyl starch (HES) fluids, states a new guideline from the AGA Institute.

In a single-center randomized trial, hydroxyethyl starch fluids conferred a 3.9-fold increase in the odds of multiorgan failure (95% confidence interval for odds ratio, 1.2-12.0) compared with normal saline in patients with acute pancreatitis, wrote guideline authors Seth D. Crockett, MD, MPH, of the University of North Carolina, Chapel Hill, and his associates. This trial and another randomized study found no mortality benefit for HES compared with fluid resuscitation. The evidence is “very low quality” but mirrors the critical care literature, according to the experts. So far, Ringer’s lactate solution and normal saline have shown similar effects on the risk of organ failure, necrosis, and mortality, but ongoing trials should better clarify this choice, they noted (Gastroenterology. doi: 10.1053/j.gastro.2018.01.032).

The guideline addresses the initial 2-week period of treating acute pancreatitis. It defines goal-directed fluid therapy as titration based on meaningful targets, such as heart rate, mean arterial pressure, central venous pressure, urine output, blood urea nitrogen concentration, and hematocrit. Studies of goal-directed fluid therapy in acute pancreatitis have been unblinded, have used inconsistent outcome measures, and have found no definite benefits over nontargeted fluid therapy, note the guideline authors. Nevertheless, they conditionally recommend goal-directed fluid therapy, partly because a randomized, blinded trial of patients with severe sepsis or septic shock (which physiologically resembles acute pancreatitis) had in-hospital mortality rates of 31% when they received goal-directed fluid therapy and 47% when they received standard fluid therapy (P = .0009).

The guideline recommends against routine use of two interventions: prophylactic antibiotics and urgent endoscopic retrograde cholangiopancreatography (ERCP) for patients with acute pancreatitis. The authors note that no evidence supports routine prophylactic antibiotics for acute pancreatitis patients without cholangitis, and that urgent ERCP did not significantly affect the risk of mortality, multiorgan failure, single-organ failure, infected pancreatic and peripancreatic necrosis, or necrotizing pancreatitis in eight randomized controlled trials of patients with acute gallstone pancreatitis.

Source: Crockett SD et al. Gastroenterology. doi: 10.1053/j.gastro.2018.01.032.

Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.

The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.

The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.

The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.

[email protected]

Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.

The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.

The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.

The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.

[email protected]

Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.

The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.

The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.

The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.

[email protected]

In patients with malignant biliary strictures, radiofrequency ablation may improve stent patency and prolong survival, according to results of a recent meta-analysis.

Radiofrequency ablation was also safe and well tolerated. The report appears in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.10.029).

Although the data to date are limited and mostly observational, radiofrequency ablation “may be a promising adjuvant therapy in patients with malignant biliary obstruction who otherwise have dismal outcomes with current standard of therapy,” wrote Aijaz Ahmed Sofi, MD, of the department of gastroenterology, Arizona Center for Digestive Health, Gilbert, and coauthors.

Use of radiofrequency ablation is thought to improve the patency of biliary stents placed as a palliative measure in patients with unresectable malignant biliary strictures. However, several studies evaluating this and other endpoints have produced “variable results,” the authors said in the report.

In a comprehensive literature search, Dr. Sofi and colleagues identified nine studies including 505 patients. Only one of the studies was randomized and controlled, and results from it were preliminary, they noted.

Combined results showed a 50.6-day pooled weighted mean difference in stent patency (95% confidence interval, 32.83-68.48) in favor of radiofrequency ablation, according to reported data. In addition, there was a significant difference in survival favoring use of radiofrequency ablation (hazard ratio, 1.395; 95% confidence interval, 1.145-1.7; P less than .001).

While there was no difference between groups in risk of cholangitis, pancreatitis, hemobilia, and acute cholecystitis, abdominal pain after the procedure was more frequent in the radiofrequency ablation group (31% vs. 20%, P = .003).

This is the first systematic review and meta-analysis evaluating radiofrequency ablation as an adjuvant therapy in patients who receive biliary stents for malignant biliary obstruction, according to the investigators.

Despite the findings, Dr. Sofi and colleagues were careful to emphasize the limitations of the analysis, writing that it provides “very low quality evidence” in favor of radiofrequency ablation therapy for management of malignant biliary strictures.

“The results of currently ongoing controlled studies examining the role of RFA [radiofrequency ablation] in malignant biliary obstruction are keenly awaited,” they wrote.

Dr. Sofi and colleagues reported no potential conflicts of interest associated with the study.

In patients with malignant biliary strictures, radiofrequency ablation may improve stent patency and prolong survival, according to results of a recent meta-analysis.

Radiofrequency ablation was also safe and well tolerated. The report appears in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.10.029).

Although the data to date are limited and mostly observational, radiofrequency ablation “may be a promising adjuvant therapy in patients with malignant biliary obstruction who otherwise have dismal outcomes with current standard of therapy,” wrote Aijaz Ahmed Sofi, MD, of the department of gastroenterology, Arizona Center for Digestive Health, Gilbert, and coauthors.

Use of radiofrequency ablation is thought to improve the patency of biliary stents placed as a palliative measure in patients with unresectable malignant biliary strictures. However, several studies evaluating this and other endpoints have produced “variable results,” the authors said in the report.

In a comprehensive literature search, Dr. Sofi and colleagues identified nine studies including 505 patients. Only one of the studies was randomized and controlled, and results from it were preliminary, they noted.

Combined results showed a 50.6-day pooled weighted mean difference in stent patency (95% confidence interval, 32.83-68.48) in favor of radiofrequency ablation, according to reported data. In addition, there was a significant difference in survival favoring use of radiofrequency ablation (hazard ratio, 1.395; 95% confidence interval, 1.145-1.7; P less than .001).

While there was no difference between groups in risk of cholangitis, pancreatitis, hemobilia, and acute cholecystitis, abdominal pain after the procedure was more frequent in the radiofrequency ablation group (31% vs. 20%, P = .003).

This is the first systematic review and meta-analysis evaluating radiofrequency ablation as an adjuvant therapy in patients who receive biliary stents for malignant biliary obstruction, according to the investigators.

Despite the findings, Dr. Sofi and colleagues were careful to emphasize the limitations of the analysis, writing that it provides “very low quality evidence” in favor of radiofrequency ablation therapy for management of malignant biliary strictures.

“The results of currently ongoing controlled studies examining the role of RFA [radiofrequency ablation] in malignant biliary obstruction are keenly awaited,” they wrote.

Dr. Sofi and colleagues reported no potential conflicts of interest associated with the study.

In patients with malignant biliary strictures, radiofrequency ablation may improve stent patency and prolong survival, according to results of a recent meta-analysis.

Radiofrequency ablation was also safe and well tolerated. The report appears in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.10.029).

Although the data to date are limited and mostly observational, radiofrequency ablation “may be a promising adjuvant therapy in patients with malignant biliary obstruction who otherwise have dismal outcomes with current standard of therapy,” wrote Aijaz Ahmed Sofi, MD, of the department of gastroenterology, Arizona Center for Digestive Health, Gilbert, and coauthors.

Use of radiofrequency ablation is thought to improve the patency of biliary stents placed as a palliative measure in patients with unresectable malignant biliary strictures. However, several studies evaluating this and other endpoints have produced “variable results,” the authors said in the report.

In a comprehensive literature search, Dr. Sofi and colleagues identified nine studies including 505 patients. Only one of the studies was randomized and controlled, and results from it were preliminary, they noted.

Combined results showed a 50.6-day pooled weighted mean difference in stent patency (95% confidence interval, 32.83-68.48) in favor of radiofrequency ablation, according to reported data. In addition, there was a significant difference in survival favoring use of radiofrequency ablation (hazard ratio, 1.395; 95% confidence interval, 1.145-1.7; P less than .001).

While there was no difference between groups in risk of cholangitis, pancreatitis, hemobilia, and acute cholecystitis, abdominal pain after the procedure was more frequent in the radiofrequency ablation group (31% vs. 20%, P = .003).

This is the first systematic review and meta-analysis evaluating radiofrequency ablation as an adjuvant therapy in patients who receive biliary stents for malignant biliary obstruction, according to the investigators.

Despite the findings, Dr. Sofi and colleagues were careful to emphasize the limitations of the analysis, writing that it provides “very low quality evidence” in favor of radiofrequency ablation therapy for management of malignant biliary strictures.

“The results of currently ongoing controlled studies examining the role of RFA [radiofrequency ablation] in malignant biliary obstruction are keenly awaited,” they wrote.

Dr. Sofi and colleagues reported no potential conflicts of interest associated with the study.

ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.

Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.

This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.

Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.

Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).

The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.

The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.

The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.

[email protected]

On Twitter @mitchelzoler

ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.

Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.

This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.

Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.

Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).

The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.

The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.

The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.

[email protected]

On Twitter @mitchelzoler

ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.

Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.

This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.

Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.

Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).

The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.

The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.

The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.

[email protected]

On Twitter @mitchelzoler

Enhanced recovery approaches were safe and effective at promoting earlier restoration of gut function in acute pancreatitis patients, according to a study presented at the World Congress of Gastroenterology at ACG 2017.

Patients recruited for the trial were admitted directly from an emergency department and received either enhanced care consisting of patient-directed oral intake, early ambulation, and nonopioid analgesia or received normal care consisting of opioid analgesia, physician-directed diet, and nursing parameters, Elizabeth Dong, MD, of the Kaiser Permanente Los Angeles Medical Center and her associates said.

Among the 46 patients included in the study, 61% had an etiology of gallstones, 15% had an etiology of alcohol, 13% had hyperglyceridemia, and 11% had a different etiology. Median age was 53.1 years, Dr. Dong and her associates noted.

Time to successful oral refeeding, the primary study endpoint, was significantly reduced in the enhanced treatment group, with a median time of 13.8 hours, compared with the normal treatment group, in which median time to oral refeeding was 124.8 hours. In addition, patients in the enhanced care group had a mean pancreatitis activity score of 43.5 after 48-72 hours, while patients in the control group had a mean score of 72.1.

Length of stay and frequency of 30-day readmission did not differ significantly between study groups.

The study was not funded by industry grants, and no disclosures were reported.

[email protected]

Enhanced recovery approaches were safe and effective at promoting earlier restoration of gut function in acute pancreatitis patients, according to a study presented at the World Congress of Gastroenterology at ACG 2017.

Patients recruited for the trial were admitted directly from an emergency department and received either enhanced care consisting of patient-directed oral intake, early ambulation, and nonopioid analgesia or received normal care consisting of opioid analgesia, physician-directed diet, and nursing parameters, Elizabeth Dong, MD, of the Kaiser Permanente Los Angeles Medical Center and her associates said.

Among the 46 patients included in the study, 61% had an etiology of gallstones, 15% had an etiology of alcohol, 13% had hyperglyceridemia, and 11% had a different etiology. Median age was 53.1 years, Dr. Dong and her associates noted.

Time to successful oral refeeding, the primary study endpoint, was significantly reduced in the enhanced treatment group, with a median time of 13.8 hours, compared with the normal treatment group, in which median time to oral refeeding was 124.8 hours. In addition, patients in the enhanced care group had a mean pancreatitis activity score of 43.5 after 48-72 hours, while patients in the control group had a mean score of 72.1.

Length of stay and frequency of 30-day readmission did not differ significantly between study groups.

The study was not funded by industry grants, and no disclosures were reported.

[email protected]

Enhanced recovery approaches were safe and effective at promoting earlier restoration of gut function in acute pancreatitis patients, according to a study presented at the World Congress of Gastroenterology at ACG 2017.

Patients recruited for the trial were admitted directly from an emergency department and received either enhanced care consisting of patient-directed oral intake, early ambulation, and nonopioid analgesia or received normal care consisting of opioid analgesia, physician-directed diet, and nursing parameters, Elizabeth Dong, MD, of the Kaiser Permanente Los Angeles Medical Center and her associates said.

Among the 46 patients included in the study, 61% had an etiology of gallstones, 15% had an etiology of alcohol, 13% had hyperglyceridemia, and 11% had a different etiology. Median age was 53.1 years, Dr. Dong and her associates noted.

Time to successful oral refeeding, the primary study endpoint, was significantly reduced in the enhanced treatment group, with a median time of 13.8 hours, compared with the normal treatment group, in which median time to oral refeeding was 124.8 hours. In addition, patients in the enhanced care group had a mean pancreatitis activity score of 43.5 after 48-72 hours, while patients in the control group had a mean score of 72.1.

Length of stay and frequency of 30-day readmission did not differ significantly between study groups.

The study was not funded by industry grants, and no disclosures were reported.

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Patients with primary biliary cholangitis (PBC) have lower lumbar spine and hip bone mineral density (BMD) and are at an increased risk of osteoporosis and fracture, according to Junyu Fan, MD, and associates.

In a meta-analysis of 210 potentially relevant articles, only 8 met the study’s criteria. Of those, five studies were pooled and the overall relationship between PBC and osteoporosis risk was assessed. Results found a significant association between PBC (n = 504) and the prevalence of osteoporosis (P = .01), compared with the control group (n = 2,052).

©eranicle/Thinkstock

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Patients with primary biliary cholangitis (PBC) have lower lumbar spine and hip bone mineral density (BMD) and are at an increased risk of osteoporosis and fracture, according to Junyu Fan, MD, and associates.

In a meta-analysis of 210 potentially relevant articles, only 8 met the study’s criteria. Of those, five studies were pooled and the overall relationship between PBC and osteoporosis risk was assessed. Results found a significant association between PBC (n = 504) and the prevalence of osteoporosis (P = .01), compared with the control group (n = 2,052).

©eranicle/Thinkstock

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Patients with primary biliary cholangitis (PBC) have lower lumbar spine and hip bone mineral density (BMD) and are at an increased risk of osteoporosis and fracture, according to Junyu Fan, MD, and associates.

In a meta-analysis of 210 potentially relevant articles, only 8 met the study’s criteria. Of those, five studies were pooled and the overall relationship between PBC and osteoporosis risk was assessed. Results found a significant association between PBC (n = 504) and the prevalence of osteoporosis (P = .01), compared with the control group (n = 2,052).

©eranicle/Thinkstock

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While primary sclerosing cholangitis (PSC) is the most common hepatobiliary disorder associated with ulcerative colitis, primary biliary cholangitis (PBC) should not be forgotten, according to Erietta Polychronopoulou, MD, and her associates.

In two case studies, a 67-year-old woman and a 71-year-old man presented with long-standing cases of asymptomatic elevation of cholestatic enzymes. Both patients had long histories of ulcerative colitis, but both were in remission. Both patients had previous clinical diagnoses of either small duct PSC or drug-induced liver injury. Both patients denied drug use, and imaging studies revealed nothing in either patient.

In testing for hepatobiliary disorders, both patients showed high titers of antimitochondrial antibodies, the hallmark of PBC. Despite the asymptomatic nature of the PBC, both patients were treated with 13 mg/kg per day ursodeoxycholic acid and have remained stable for 17 and 18 months, respectively.

“The relationship of PBC with UC [ulcerative colitis] remains obscure as there are few reported cases regarding the combined presentation of these diseases. Although the pathogenesis of either disease has not yet been completely clarified, environmental and genetic factors are considered important in the susceptibility to both diseases, suggesting that the two diseases may share common immunopathogenetic pathways,” the investigators noted.

Find the full report in BMJ Case Reports (2017 Sep 25. doi: 10.1136/bcr-2017-220824).
 

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While primary sclerosing cholangitis (PSC) is the most common hepatobiliary disorder associated with ulcerative colitis, primary biliary cholangitis (PBC) should not be forgotten, according to Erietta Polychronopoulou, MD, and her associates.

In two case studies, a 67-year-old woman and a 71-year-old man presented with long-standing cases of asymptomatic elevation of cholestatic enzymes. Both patients had long histories of ulcerative colitis, but both were in remission. Both patients had previous clinical diagnoses of either small duct PSC or drug-induced liver injury. Both patients denied drug use, and imaging studies revealed nothing in either patient.

In testing for hepatobiliary disorders, both patients showed high titers of antimitochondrial antibodies, the hallmark of PBC. Despite the asymptomatic nature of the PBC, both patients were treated with 13 mg/kg per day ursodeoxycholic acid and have remained stable for 17 and 18 months, respectively.

“The relationship of PBC with UC [ulcerative colitis] remains obscure as there are few reported cases regarding the combined presentation of these diseases. Although the pathogenesis of either disease has not yet been completely clarified, environmental and genetic factors are considered important in the susceptibility to both diseases, suggesting that the two diseases may share common immunopathogenetic pathways,” the investigators noted.

Find the full report in BMJ Case Reports (2017 Sep 25. doi: 10.1136/bcr-2017-220824).
 

[email protected]

While primary sclerosing cholangitis (PSC) is the most common hepatobiliary disorder associated with ulcerative colitis, primary biliary cholangitis (PBC) should not be forgotten, according to Erietta Polychronopoulou, MD, and her associates.

In two case studies, a 67-year-old woman and a 71-year-old man presented with long-standing cases of asymptomatic elevation of cholestatic enzymes. Both patients had long histories of ulcerative colitis, but both were in remission. Both patients had previous clinical diagnoses of either small duct PSC or drug-induced liver injury. Both patients denied drug use, and imaging studies revealed nothing in either patient.

In testing for hepatobiliary disorders, both patients showed high titers of antimitochondrial antibodies, the hallmark of PBC. Despite the asymptomatic nature of the PBC, both patients were treated with 13 mg/kg per day ursodeoxycholic acid and have remained stable for 17 and 18 months, respectively.

“The relationship of PBC with UC [ulcerative colitis] remains obscure as there are few reported cases regarding the combined presentation of these diseases. Although the pathogenesis of either disease has not yet been completely clarified, environmental and genetic factors are considered important in the susceptibility to both diseases, suggesting that the two diseases may share common immunopathogenetic pathways,” the investigators noted.

Find the full report in BMJ Case Reports (2017 Sep 25. doi: 10.1136/bcr-2017-220824).
 

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The session titled “The biliary tree and pancreas” provided an overview of the most important pancreaticobiliary diseases, allowing experts to delineate their approaches to challenging aspects of these conditions.

Timothy Gardner, MD, MS, focused on the management and treatment of sequelae in patients with acute pancreatitis. He provided support for the use of lactated Ringer’s as the fluid of choice, cautioning against over-resuscitation. He advised early oral feeds, without clear preference for nasogastric or nasojejunal administration. Dr. Gardner emphasized the importance of classifying type of fluid collection to optimize clinical decision making. Endoscopic techniques appear to be safer and as efficacious as surgical approaches. Regarding thrombosis, anticoagulation was recommended unless an absolute contraindication exists. He also recommended addressing symptomatic ductal disruptions.

Dr. Kim is an assistant professor of gastroenterology at Mount Sinai Hospital, acting director of endoscopy, and director of endoscopic ultrasound at Mount Sinai Hospital, New York. This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017.

The session titled “The biliary tree and pancreas” provided an overview of the most important pancreaticobiliary diseases, allowing experts to delineate their approaches to challenging aspects of these conditions.

Timothy Gardner, MD, MS, focused on the management and treatment of sequelae in patients with acute pancreatitis. He provided support for the use of lactated Ringer’s as the fluid of choice, cautioning against over-resuscitation. He advised early oral feeds, without clear preference for nasogastric or nasojejunal administration. Dr. Gardner emphasized the importance of classifying type of fluid collection to optimize clinical decision making. Endoscopic techniques appear to be safer and as efficacious as surgical approaches. Regarding thrombosis, anticoagulation was recommended unless an absolute contraindication exists. He also recommended addressing symptomatic ductal disruptions.

Dr. Kim is an assistant professor of gastroenterology at Mount Sinai Hospital, acting director of endoscopy, and director of endoscopic ultrasound at Mount Sinai Hospital, New York. This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017.

The session titled “The biliary tree and pancreas” provided an overview of the most important pancreaticobiliary diseases, allowing experts to delineate their approaches to challenging aspects of these conditions.

Timothy Gardner, MD, MS, focused on the management and treatment of sequelae in patients with acute pancreatitis. He provided support for the use of lactated Ringer’s as the fluid of choice, cautioning against over-resuscitation. He advised early oral feeds, without clear preference for nasogastric or nasojejunal administration. Dr. Gardner emphasized the importance of classifying type of fluid collection to optimize clinical decision making. Endoscopic techniques appear to be safer and as efficacious as surgical approaches. Regarding thrombosis, anticoagulation was recommended unless an absolute contraindication exists. He also recommended addressing symptomatic ductal disruptions.

Dr. Kim is an assistant professor of gastroenterology at Mount Sinai Hospital, acting director of endoscopy, and director of endoscopic ultrasound at Mount Sinai Hospital, New York. This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017.

The incidence of primary biliary cholangitis (PBC) in rural parts of the midwestern United States has remained stable over the last 2 decades, allowing better prognosis and improved survival rates.

In a population-based cohort study, Rajan Kanth, MD, and his associates researched 79 incident PBC cases observed in the Marshfield Epidemiologic Study Area (MESA) of 24 zip codes in central and northern Wisconsin between 1992 and 2011. The overall age- and sex-standardized PBC incidence rate was 4.9 cases per 100,000 person-years. The annual incidence rate of PBC increased; however, it was not significant (P = .114) during the 20-year study time frame. In women, PBC ranged from a low of 6.9 cases per 100,000 person-years in 1992-1996 to a high of 11.3 cases per 100,000 person-years in 2002-2006. The sex-specific comparisons were not significant at any time during the 5-year period.

After a mean follow-up of 7.3 years, 23 (29%) patients with PBC died. The estimated 10-year survival of PBC cases in MESA was 76%.

Researchers noted the MESA source population grew over the 20-year study time frame, going from a low of 364,722 MESA person-years in 1992-1996 to a high of 409,670 person-years in 2007-2011. The proportion of men and women in MESA were consistent throughout the study, but there was a general population aging trend with a 29% increase in the number of individuals aged 40-69 years in 2007-2011 relative to 1992-1996.

“The overall incidence of PBC in a Midwestern population of the United States has remained relatively stable over the last two decades,” researchers concluded. “Results suggest that the overall incidence of PBC in the United States is not rising quickly, and that patients with PBC have generally improved prognosis and survival.”

Find the full study in Clinical Medicine & Research (2017. doi: 10.3121/cmr.2017.1351).

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The incidence of primary biliary cholangitis (PBC) in rural parts of the midwestern United States has remained stable over the last 2 decades, allowing better prognosis and improved survival rates.

In a population-based cohort study, Rajan Kanth, MD, and his associates researched 79 incident PBC cases observed in the Marshfield Epidemiologic Study Area (MESA) of 24 zip codes in central and northern Wisconsin between 1992 and 2011. The overall age- and sex-standardized PBC incidence rate was 4.9 cases per 100,000 person-years. The annual incidence rate of PBC increased; however, it was not significant (P = .114) during the 20-year study time frame. In women, PBC ranged from a low of 6.9 cases per 100,000 person-years in 1992-1996 to a high of 11.3 cases per 100,000 person-years in 2002-2006. The sex-specific comparisons were not significant at any time during the 5-year period.

After a mean follow-up of 7.3 years, 23 (29%) patients with PBC died. The estimated 10-year survival of PBC cases in MESA was 76%.

Researchers noted the MESA source population grew over the 20-year study time frame, going from a low of 364,722 MESA person-years in 1992-1996 to a high of 409,670 person-years in 2007-2011. The proportion of men and women in MESA were consistent throughout the study, but there was a general population aging trend with a 29% increase in the number of individuals aged 40-69 years in 2007-2011 relative to 1992-1996.

“The overall incidence of PBC in a Midwestern population of the United States has remained relatively stable over the last two decades,” researchers concluded. “Results suggest that the overall incidence of PBC in the United States is not rising quickly, and that patients with PBC have generally improved prognosis and survival.”

Find the full study in Clinical Medicine & Research (2017. doi: 10.3121/cmr.2017.1351).

[email protected]

The incidence of primary biliary cholangitis (PBC) in rural parts of the midwestern United States has remained stable over the last 2 decades, allowing better prognosis and improved survival rates.

In a population-based cohort study, Rajan Kanth, MD, and his associates researched 79 incident PBC cases observed in the Marshfield Epidemiologic Study Area (MESA) of 24 zip codes in central and northern Wisconsin between 1992 and 2011. The overall age- and sex-standardized PBC incidence rate was 4.9 cases per 100,000 person-years. The annual incidence rate of PBC increased; however, it was not significant (P = .114) during the 20-year study time frame. In women, PBC ranged from a low of 6.9 cases per 100,000 person-years in 1992-1996 to a high of 11.3 cases per 100,000 person-years in 2002-2006. The sex-specific comparisons were not significant at any time during the 5-year period.

After a mean follow-up of 7.3 years, 23 (29%) patients with PBC died. The estimated 10-year survival of PBC cases in MESA was 76%.

Researchers noted the MESA source population grew over the 20-year study time frame, going from a low of 364,722 MESA person-years in 1992-1996 to a high of 409,670 person-years in 2007-2011. The proportion of men and women in MESA were consistent throughout the study, but there was a general population aging trend with a 29% increase in the number of individuals aged 40-69 years in 2007-2011 relative to 1992-1996.

“The overall incidence of PBC in a Midwestern population of the United States has remained relatively stable over the last two decades,” researchers concluded. “Results suggest that the overall incidence of PBC in the United States is not rising quickly, and that patients with PBC have generally improved prognosis and survival.”

Find the full study in Clinical Medicine & Research (2017. doi: 10.3121/cmr.2017.1351).

[email protected]