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Endoscopic cystogastrostomy was as effective as surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial comparing the two approaches.
None of the 20 patients randomized to undergo endoscopic treatment, and 1 of 20 patients randomized to undergo surgery, experienced pseudocyst recurrence within 24 months of follow-up, Dr. Shyam Varadarajulu of the University of Alabama at Birmingham and his colleagues reported online May 31, ahead of print in Gastroenterology.
Source: American Gastroenterological Association
Moreover, those in the endoscopy group had a shorter hospital length of stay than did the patients in the surgery group (median of 2 vs. 6 days) and a lower mean cost of care ($7,011 vs. $15,052), the investigators reported (Gastroenterology 2013 May 31 [doi: 10.1053/j.gastro.2013.05.046]).
Patients included in the study were adults with intrapancreatic or extrapancreatic pseudocysts who were enrolled between Jan. 20 and Dec. 28, 2009, following evaluation by a gastroenterologist or surgeon in an outpatient clinic or inpatient setting.
The 20 patients in the endoscopy group underwent cystogastrostomy using endoscopic ultrasound guidance and fluoroscopy while they were under conscious sedation.
"Once the pseudocyst was identified, it was accessed using a 19-gauge needle, and the gastric wall was dilated up to 15 mm using a wire-guided balloon. Two plastic stents then were deployed to facilitate the drainage of pseudocyst contents into the stomach," the investigators explained, noting that endoscopy patients were discharged following the procedure.
No procedural complications occurred in any of the 20 patients. However, one patient presented to the hospital 13 days later with persistent abdominal pain; a computed tomography scan showed a residual 7-cm pseudocyst, which was successfully treated by deployment of additional stents. At 8-week follow-up, abdominal CT scans showed pseudocyst resolution in all 20 patients.
Endoscopic retrograde cholangiopancreatography (ERCP), which was performed in all of the endoscopy patients to assess and treat any pancreatic duct leaks, was successful in 18 of the 20 patients. Magnetic resonance cholangiopancreatography (MRCP), performed in those two patients, showed a normal pancreatic duct in one and a disconnected duct in the other, the investigators said.
The 20 patients in the surgery group were all treated by the same pancreatic surgeon, who used an endovascular stapler to create at least a 6-cm cystogastrostomy after obtaining entry to the pseudocyst.
"A nasogastric tube then was left in the stomach and passed into the pseudocyst cavity to allow for intermittent irrigation until postoperative day 1 ... the nasogastric tube was removed on postoperative day 1 and clear liquids were started on day 2," they said.
Patients were discharged once a soft diet was tolerated and pain adequately controlled.
One patient with ongoing alcohol consumption developed pseudocyst recurrence at 4 months and was managed by endoscopic cystogastrostomy.
Two surgery patients experienced complications, including a wound infection treated by local debridement and antibiotics in one patient, and a case of hematemesis in one patient who was on anticoagulation and who was readmitted 9 days after discharge. "At endoscopy, a visible clot was noted at the site of surgical anastomosis, and hemostasis was achieved by application of electrocautery," the investigators said.
Two other patients were not able to tolerate oral intake postoperatively; one of them was managed conservatively, and one required surgical placement of a temporary enteral feeding tube. In addition, one patient presented at 6 months with abdominal pain and was found on ERCP to have a stricture in the pancreatic tail that required management by distal pancreatectomy.
Overall, there were no differences in the rates of treatment success, treatment failure, complications, or reinterventions between the endoscopy and surgery groups.
However, in addition to the shorter hospital stay and lower costs in the endoscopy group, patients in that group had significantly greater improvement over time in physical and mental health component scores on the Medical Outcomes Study 36-Item Short-Form General Survey. Although the scores improved for both cohorts, they were 4.48 points and 4.41 points lower, respectively, in the surgery group than the endoscopy group, the investigators said.
The findings are of note because although endoscopic drainage of pancreatic pseudocysts is increasingly performed, surgical cystogastrostomy is still considered the gold standard for treatment, as randomized trials comparing the two approaches had not previously been performed.
"The clinical relevance of this study is substantial because it shows that endoscopically managed patients can be discharged home earlier with a better health-related quality of life, and treatment can be delivered at a lower cost," the investigators said.
The authors reported having no disclosures.
There has been marked evolution in the understanding and management of acute and chronic pancreatitis over the last decade. Walled-off necroses and pseudocysts are consequences of pancreatitis that may be intrapancreatic, extrapancreatic, or both. These two entities are often confused. Fortunately, a recent international consensus has clarified that pseudocysts are liquid-filled, are almost always extrapancreatic, and rarely occur as the consequence of severe pancreatitis or involve "disconnected duct" (Gut 2013;62:102-11).
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| Dr. Martin L. Freeman |
Dr. Varadarajulu and his colleagues are to be congratulated for performing a landmark study comparing surgery and endoscopy for internal drainage of pseudocysts (Gastroenterology 2013 May 31 [doi: 10.1053/j.gastro.2013.05.046]). They covered all the bases for an outstanding efficacy trial, including performance by experts at a tertiary center, and careful definitions of endpoints. Although the title of the paper is "Equal efficacy … [of the two approaches]," based on the primary endpoint of recurrence at 24 months, they addressed cost, hospital stay, and quality of life measures, all increasingly important in the current health care environment. In the latter regard, endoscopic ultrasound-guided cystgastrostomy emerged to be clearly superior to open surgery. If patients with more comorbidity such as portal hypertension were included, the differences would likely have been even more striking.
Thus, for pseudocysts, as for walled-off necroses, the picture is becoming increasingly clear: Minimally invasive and in particular endoscopic techniques are superior to open surgical approaches. This represents a paradigm shift in clinical practice. However, to be effective and safe in widespread applicability, it is incumbent that endoscopists attempting to manage these conditions have highly specialized expertise in pancreatic diseases and techniques, and manage these complex patients in close collaboration with their colleagues in surgery and interventional radiology.
Dr. Martin L. Freeman, FACG, FASGE, is professor of medicine at the University of Minnesota, Minneapolis. He disclosed receiving speaking honoraria from Boston Scientific and Cook, and consulting for Boston Scientific.
There has been marked evolution in the understanding and management of acute and chronic pancreatitis over the last decade. Walled-off necroses and pseudocysts are consequences of pancreatitis that may be intrapancreatic, extrapancreatic, or both. These two entities are often confused. Fortunately, a recent international consensus has clarified that pseudocysts are liquid-filled, are almost always extrapancreatic, and rarely occur as the consequence of severe pancreatitis or involve "disconnected duct" (Gut 2013;62:102-11).
|
| Dr. Martin L. Freeman |
Dr. Varadarajulu and his colleagues are to be congratulated for performing a landmark study comparing surgery and endoscopy for internal drainage of pseudocysts (Gastroenterology 2013 May 31 [doi: 10.1053/j.gastro.2013.05.046]). They covered all the bases for an outstanding efficacy trial, including performance by experts at a tertiary center, and careful definitions of endpoints. Although the title of the paper is "Equal efficacy … [of the two approaches]," based on the primary endpoint of recurrence at 24 months, they addressed cost, hospital stay, and quality of life measures, all increasingly important in the current health care environment. In the latter regard, endoscopic ultrasound-guided cystgastrostomy emerged to be clearly superior to open surgery. If patients with more comorbidity such as portal hypertension were included, the differences would likely have been even more striking.
Thus, for pseudocysts, as for walled-off necroses, the picture is becoming increasingly clear: Minimally invasive and in particular endoscopic techniques are superior to open surgical approaches. This represents a paradigm shift in clinical practice. However, to be effective and safe in widespread applicability, it is incumbent that endoscopists attempting to manage these conditions have highly specialized expertise in pancreatic diseases and techniques, and manage these complex patients in close collaboration with their colleagues in surgery and interventional radiology.
Dr. Martin L. Freeman, FACG, FASGE, is professor of medicine at the University of Minnesota, Minneapolis. He disclosed receiving speaking honoraria from Boston Scientific and Cook, and consulting for Boston Scientific.
There has been marked evolution in the understanding and management of acute and chronic pancreatitis over the last decade. Walled-off necroses and pseudocysts are consequences of pancreatitis that may be intrapancreatic, extrapancreatic, or both. These two entities are often confused. Fortunately, a recent international consensus has clarified that pseudocysts are liquid-filled, are almost always extrapancreatic, and rarely occur as the consequence of severe pancreatitis or involve "disconnected duct" (Gut 2013;62:102-11).
|
| Dr. Martin L. Freeman |
Dr. Varadarajulu and his colleagues are to be congratulated for performing a landmark study comparing surgery and endoscopy for internal drainage of pseudocysts (Gastroenterology 2013 May 31 [doi: 10.1053/j.gastro.2013.05.046]). They covered all the bases for an outstanding efficacy trial, including performance by experts at a tertiary center, and careful definitions of endpoints. Although the title of the paper is "Equal efficacy … [of the two approaches]," based on the primary endpoint of recurrence at 24 months, they addressed cost, hospital stay, and quality of life measures, all increasingly important in the current health care environment. In the latter regard, endoscopic ultrasound-guided cystgastrostomy emerged to be clearly superior to open surgery. If patients with more comorbidity such as portal hypertension were included, the differences would likely have been even more striking.
Thus, for pseudocysts, as for walled-off necroses, the picture is becoming increasingly clear: Minimally invasive and in particular endoscopic techniques are superior to open surgical approaches. This represents a paradigm shift in clinical practice. However, to be effective and safe in widespread applicability, it is incumbent that endoscopists attempting to manage these conditions have highly specialized expertise in pancreatic diseases and techniques, and manage these complex patients in close collaboration with their colleagues in surgery and interventional radiology.
Dr. Martin L. Freeman, FACG, FASGE, is professor of medicine at the University of Minnesota, Minneapolis. He disclosed receiving speaking honoraria from Boston Scientific and Cook, and consulting for Boston Scientific.
Endoscopic cystogastrostomy was as effective as surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial comparing the two approaches.
None of the 20 patients randomized to undergo endoscopic treatment, and 1 of 20 patients randomized to undergo surgery, experienced pseudocyst recurrence within 24 months of follow-up, Dr. Shyam Varadarajulu of the University of Alabama at Birmingham and his colleagues reported online May 31, ahead of print in Gastroenterology.
Source: American Gastroenterological Association
Moreover, those in the endoscopy group had a shorter hospital length of stay than did the patients in the surgery group (median of 2 vs. 6 days) and a lower mean cost of care ($7,011 vs. $15,052), the investigators reported (Gastroenterology 2013 May 31 [doi: 10.1053/j.gastro.2013.05.046]).
Patients included in the study were adults with intrapancreatic or extrapancreatic pseudocysts who were enrolled between Jan. 20 and Dec. 28, 2009, following evaluation by a gastroenterologist or surgeon in an outpatient clinic or inpatient setting.
The 20 patients in the endoscopy group underwent cystogastrostomy using endoscopic ultrasound guidance and fluoroscopy while they were under conscious sedation.
"Once the pseudocyst was identified, it was accessed using a 19-gauge needle, and the gastric wall was dilated up to 15 mm using a wire-guided balloon. Two plastic stents then were deployed to facilitate the drainage of pseudocyst contents into the stomach," the investigators explained, noting that endoscopy patients were discharged following the procedure.
No procedural complications occurred in any of the 20 patients. However, one patient presented to the hospital 13 days later with persistent abdominal pain; a computed tomography scan showed a residual 7-cm pseudocyst, which was successfully treated by deployment of additional stents. At 8-week follow-up, abdominal CT scans showed pseudocyst resolution in all 20 patients.
Endoscopic retrograde cholangiopancreatography (ERCP), which was performed in all of the endoscopy patients to assess and treat any pancreatic duct leaks, was successful in 18 of the 20 patients. Magnetic resonance cholangiopancreatography (MRCP), performed in those two patients, showed a normal pancreatic duct in one and a disconnected duct in the other, the investigators said.
The 20 patients in the surgery group were all treated by the same pancreatic surgeon, who used an endovascular stapler to create at least a 6-cm cystogastrostomy after obtaining entry to the pseudocyst.
"A nasogastric tube then was left in the stomach and passed into the pseudocyst cavity to allow for intermittent irrigation until postoperative day 1 ... the nasogastric tube was removed on postoperative day 1 and clear liquids were started on day 2," they said.
Patients were discharged once a soft diet was tolerated and pain adequately controlled.
One patient with ongoing alcohol consumption developed pseudocyst recurrence at 4 months and was managed by endoscopic cystogastrostomy.
Two surgery patients experienced complications, including a wound infection treated by local debridement and antibiotics in one patient, and a case of hematemesis in one patient who was on anticoagulation and who was readmitted 9 days after discharge. "At endoscopy, a visible clot was noted at the site of surgical anastomosis, and hemostasis was achieved by application of electrocautery," the investigators said.
Two other patients were not able to tolerate oral intake postoperatively; one of them was managed conservatively, and one required surgical placement of a temporary enteral feeding tube. In addition, one patient presented at 6 months with abdominal pain and was found on ERCP to have a stricture in the pancreatic tail that required management by distal pancreatectomy.
Overall, there were no differences in the rates of treatment success, treatment failure, complications, or reinterventions between the endoscopy and surgery groups.
However, in addition to the shorter hospital stay and lower costs in the endoscopy group, patients in that group had significantly greater improvement over time in physical and mental health component scores on the Medical Outcomes Study 36-Item Short-Form General Survey. Although the scores improved for both cohorts, they were 4.48 points and 4.41 points lower, respectively, in the surgery group than the endoscopy group, the investigators said.
The findings are of note because although endoscopic drainage of pancreatic pseudocysts is increasingly performed, surgical cystogastrostomy is still considered the gold standard for treatment, as randomized trials comparing the two approaches had not previously been performed.
"The clinical relevance of this study is substantial because it shows that endoscopically managed patients can be discharged home earlier with a better health-related quality of life, and treatment can be delivered at a lower cost," the investigators said.
The authors reported having no disclosures.
Endoscopic cystogastrostomy was as effective as surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial comparing the two approaches.
None of the 20 patients randomized to undergo endoscopic treatment, and 1 of 20 patients randomized to undergo surgery, experienced pseudocyst recurrence within 24 months of follow-up, Dr. Shyam Varadarajulu of the University of Alabama at Birmingham and his colleagues reported online May 31, ahead of print in Gastroenterology.
Source: American Gastroenterological Association
Moreover, those in the endoscopy group had a shorter hospital length of stay than did the patients in the surgery group (median of 2 vs. 6 days) and a lower mean cost of care ($7,011 vs. $15,052), the investigators reported (Gastroenterology 2013 May 31 [doi: 10.1053/j.gastro.2013.05.046]).
Patients included in the study were adults with intrapancreatic or extrapancreatic pseudocysts who were enrolled between Jan. 20 and Dec. 28, 2009, following evaluation by a gastroenterologist or surgeon in an outpatient clinic or inpatient setting.
The 20 patients in the endoscopy group underwent cystogastrostomy using endoscopic ultrasound guidance and fluoroscopy while they were under conscious sedation.
"Once the pseudocyst was identified, it was accessed using a 19-gauge needle, and the gastric wall was dilated up to 15 mm using a wire-guided balloon. Two plastic stents then were deployed to facilitate the drainage of pseudocyst contents into the stomach," the investigators explained, noting that endoscopy patients were discharged following the procedure.
No procedural complications occurred in any of the 20 patients. However, one patient presented to the hospital 13 days later with persistent abdominal pain; a computed tomography scan showed a residual 7-cm pseudocyst, which was successfully treated by deployment of additional stents. At 8-week follow-up, abdominal CT scans showed pseudocyst resolution in all 20 patients.
Endoscopic retrograde cholangiopancreatography (ERCP), which was performed in all of the endoscopy patients to assess and treat any pancreatic duct leaks, was successful in 18 of the 20 patients. Magnetic resonance cholangiopancreatography (MRCP), performed in those two patients, showed a normal pancreatic duct in one and a disconnected duct in the other, the investigators said.
The 20 patients in the surgery group were all treated by the same pancreatic surgeon, who used an endovascular stapler to create at least a 6-cm cystogastrostomy after obtaining entry to the pseudocyst.
"A nasogastric tube then was left in the stomach and passed into the pseudocyst cavity to allow for intermittent irrigation until postoperative day 1 ... the nasogastric tube was removed on postoperative day 1 and clear liquids were started on day 2," they said.
Patients were discharged once a soft diet was tolerated and pain adequately controlled.
One patient with ongoing alcohol consumption developed pseudocyst recurrence at 4 months and was managed by endoscopic cystogastrostomy.
Two surgery patients experienced complications, including a wound infection treated by local debridement and antibiotics in one patient, and a case of hematemesis in one patient who was on anticoagulation and who was readmitted 9 days after discharge. "At endoscopy, a visible clot was noted at the site of surgical anastomosis, and hemostasis was achieved by application of electrocautery," the investigators said.
Two other patients were not able to tolerate oral intake postoperatively; one of them was managed conservatively, and one required surgical placement of a temporary enteral feeding tube. In addition, one patient presented at 6 months with abdominal pain and was found on ERCP to have a stricture in the pancreatic tail that required management by distal pancreatectomy.
Overall, there were no differences in the rates of treatment success, treatment failure, complications, or reinterventions between the endoscopy and surgery groups.
However, in addition to the shorter hospital stay and lower costs in the endoscopy group, patients in that group had significantly greater improvement over time in physical and mental health component scores on the Medical Outcomes Study 36-Item Short-Form General Survey. Although the scores improved for both cohorts, they were 4.48 points and 4.41 points lower, respectively, in the surgery group than the endoscopy group, the investigators said.
The findings are of note because although endoscopic drainage of pancreatic pseudocysts is increasingly performed, surgical cystogastrostomy is still considered the gold standard for treatment, as randomized trials comparing the two approaches had not previously been performed.
"The clinical relevance of this study is substantial because it shows that endoscopically managed patients can be discharged home earlier with a better health-related quality of life, and treatment can be delivered at a lower cost," the investigators said.
The authors reported having no disclosures.
FROM GASTROENTEROLOGY
Major finding: Pseudocysts recurred in 0 of 20 endoscopy patients, and 1 of 20 surgery patients.
Data source: An open-label randomized trial involving 40 patients.
Disclosures: The authors reported having no disclosures.
