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Lucas Franki is an associate editor for MDedge News, and has been with the company since 2014. He has a BA in English from Penn State University and is an Eagle Scout.
FDA approves first duodenoscope with disposable distal cap
, according to an FDA press release.
A disposable distal cap will improve the ability to clean and reprocess the duodenoscope. Without being thoroughly cleaned and disinfected, contaminated tissue can remain and potentially can be transmitted to other patients.
A previous version of the Pentax duodenoscope, the ED-3490TK, was subject to a January 2017 FDA Safety Alert, because of the potential for cracks and gaps to develop in the adhesive sealing the duodenoscope’s distal cap.
“Since the issue of duodenoscope-associated transmission of infections first received widespread attention in 2015, the AGA Center for GI Innovation and Technology has been working closely with regulators and endoscope manufacturers to identify and address problems in scope design and develop a path forward to ensure zero device-associated infections,” said V. Raman Muthusamy, MD, AGAF, FACG, FASGE, chair, AGA Center for GI Innovation and Technology. “We applaud Pentax for answering our call for innovation to improve patient safety for this common and life-saving GI procedure. We encourage all device manufacturers to continue on a path of innovation to better support gastroenterologists and, most importantly, the patients we serve.”
, according to an FDA press release.
A disposable distal cap will improve the ability to clean and reprocess the duodenoscope. Without being thoroughly cleaned and disinfected, contaminated tissue can remain and potentially can be transmitted to other patients.
A previous version of the Pentax duodenoscope, the ED-3490TK, was subject to a January 2017 FDA Safety Alert, because of the potential for cracks and gaps to develop in the adhesive sealing the duodenoscope’s distal cap.
“Since the issue of duodenoscope-associated transmission of infections first received widespread attention in 2015, the AGA Center for GI Innovation and Technology has been working closely with regulators and endoscope manufacturers to identify and address problems in scope design and develop a path forward to ensure zero device-associated infections,” said V. Raman Muthusamy, MD, AGAF, FACG, FASGE, chair, AGA Center for GI Innovation and Technology. “We applaud Pentax for answering our call for innovation to improve patient safety for this common and life-saving GI procedure. We encourage all device manufacturers to continue on a path of innovation to better support gastroenterologists and, most importantly, the patients we serve.”
, according to an FDA press release.
A disposable distal cap will improve the ability to clean and reprocess the duodenoscope. Without being thoroughly cleaned and disinfected, contaminated tissue can remain and potentially can be transmitted to other patients.
A previous version of the Pentax duodenoscope, the ED-3490TK, was subject to a January 2017 FDA Safety Alert, because of the potential for cracks and gaps to develop in the adhesive sealing the duodenoscope’s distal cap.
“Since the issue of duodenoscope-associated transmission of infections first received widespread attention in 2015, the AGA Center for GI Innovation and Technology has been working closely with regulators and endoscope manufacturers to identify and address problems in scope design and develop a path forward to ensure zero device-associated infections,” said V. Raman Muthusamy, MD, AGAF, FACG, FASGE, chair, AGA Center for GI Innovation and Technology. “We applaud Pentax for answering our call for innovation to improve patient safety for this common and life-saving GI procedure. We encourage all device manufacturers to continue on a path of innovation to better support gastroenterologists and, most importantly, the patients we serve.”
FDA approves nivolumab for HCC patients
The Food and Drug Administration has granted accelerated approval to nivolumab (Optivo) for the treatment of patients with hepatocellular carcinoma (HCC) who have been treated previously with sorafenib.
Approval was based on tumor response rate and durability of response from the phase 1/2 Checkmate 040 trial. Of 154 patients with HCC in the trial who received nivolumab following progression on sorafenib, 3 experienced complete response, and 19 experienced partial response. Median time to response was 2.8 months, and 91% of patients who responded to treatment had a response length longer than 6 months, with 55% of patients having a response length longer than 1 year.
“In recent years, there has been growing interest in leveraging immuno-oncology knowledge and discoveries to add to the treatment options available for patients with advanced-stage liver cancer. The approval of Opdivo provides us with an encouraging approach and a new treatment option for appropriate patients with HCC following prior systemic therapy,” Anthony B. El-Khoueiry, MD, a medical oncologist and phase 1 program director at the University of Southern California, Los Angeles, and the USC Norris Comprehensive Cancer Center, said in the press release.
The Food and Drug Administration has granted accelerated approval to nivolumab (Optivo) for the treatment of patients with hepatocellular carcinoma (HCC) who have been treated previously with sorafenib.
Approval was based on tumor response rate and durability of response from the phase 1/2 Checkmate 040 trial. Of 154 patients with HCC in the trial who received nivolumab following progression on sorafenib, 3 experienced complete response, and 19 experienced partial response. Median time to response was 2.8 months, and 91% of patients who responded to treatment had a response length longer than 6 months, with 55% of patients having a response length longer than 1 year.
“In recent years, there has been growing interest in leveraging immuno-oncology knowledge and discoveries to add to the treatment options available for patients with advanced-stage liver cancer. The approval of Opdivo provides us with an encouraging approach and a new treatment option for appropriate patients with HCC following prior systemic therapy,” Anthony B. El-Khoueiry, MD, a medical oncologist and phase 1 program director at the University of Southern California, Los Angeles, and the USC Norris Comprehensive Cancer Center, said in the press release.
The Food and Drug Administration has granted accelerated approval to nivolumab (Optivo) for the treatment of patients with hepatocellular carcinoma (HCC) who have been treated previously with sorafenib.
Approval was based on tumor response rate and durability of response from the phase 1/2 Checkmate 040 trial. Of 154 patients with HCC in the trial who received nivolumab following progression on sorafenib, 3 experienced complete response, and 19 experienced partial response. Median time to response was 2.8 months, and 91% of patients who responded to treatment had a response length longer than 6 months, with 55% of patients having a response length longer than 1 year.
“In recent years, there has been growing interest in leveraging immuno-oncology knowledge and discoveries to add to the treatment options available for patients with advanced-stage liver cancer. The approval of Opdivo provides us with an encouraging approach and a new treatment option for appropriate patients with HCC following prior systemic therapy,” Anthony B. El-Khoueiry, MD, a medical oncologist and phase 1 program director at the University of Southern California, Los Angeles, and the USC Norris Comprehensive Cancer Center, said in the press release.
Rapid genomic testing can diagnose critically ill infants
Rapid, targeted genomic sequencing shows promise in quickly diagnosing critically ill infants for whom standard clinical work-ups were unsuccessful, according to Cleo C. van Diemen, PhD, of the University of Groningen (the Netherlands), and associates.
Over the course of 1 year, 23 critically ill infants younger than 12 months who had no clear diagnosis after standard clinical work-ups underwent rapid, targeted genomics, with 7 receiving a genetic diagnosis. The median turnaround time was 12 days, falling from roughly 3 weeks at the beginning of the study to a maximum of 8 days by the end of the study.
Compound heterozygous mutations in the EPG5, RMND1, and EIF2B5 genes allowed for diagnoses of Vici syndrome, combined oxidative phosphorylation deficiency-11, and vanishing white matter, respectively. Homozygous mutations in the KLHL41, GFER, and GLB1 genes allowed for diagnoses of nemaline myopathy, progressive mitochondrial myopathy, and GM1-gangliosidosis, respectively. In addition, a 1p36.33p36.32 microdeletion was discovered in an infant with cardiomyopathy.
“The clinical relevance of rapid genome diagnostics lies in the fact that these results can be used in the clinical decisions made in caring for critically ill children in ICUs, in better genetic counseling of the parents, and in guiding their future reproductive choices,” the investigators noted.
Find the full study in Pediatrics (2017 Sep 22. doi: 10.1542/ peds.2016-2854).
Rapid, targeted genomic sequencing shows promise in quickly diagnosing critically ill infants for whom standard clinical work-ups were unsuccessful, according to Cleo C. van Diemen, PhD, of the University of Groningen (the Netherlands), and associates.
Over the course of 1 year, 23 critically ill infants younger than 12 months who had no clear diagnosis after standard clinical work-ups underwent rapid, targeted genomics, with 7 receiving a genetic diagnosis. The median turnaround time was 12 days, falling from roughly 3 weeks at the beginning of the study to a maximum of 8 days by the end of the study.
Compound heterozygous mutations in the EPG5, RMND1, and EIF2B5 genes allowed for diagnoses of Vici syndrome, combined oxidative phosphorylation deficiency-11, and vanishing white matter, respectively. Homozygous mutations in the KLHL41, GFER, and GLB1 genes allowed for diagnoses of nemaline myopathy, progressive mitochondrial myopathy, and GM1-gangliosidosis, respectively. In addition, a 1p36.33p36.32 microdeletion was discovered in an infant with cardiomyopathy.
“The clinical relevance of rapid genome diagnostics lies in the fact that these results can be used in the clinical decisions made in caring for critically ill children in ICUs, in better genetic counseling of the parents, and in guiding their future reproductive choices,” the investigators noted.
Find the full study in Pediatrics (2017 Sep 22. doi: 10.1542/ peds.2016-2854).
Rapid, targeted genomic sequencing shows promise in quickly diagnosing critically ill infants for whom standard clinical work-ups were unsuccessful, according to Cleo C. van Diemen, PhD, of the University of Groningen (the Netherlands), and associates.
Over the course of 1 year, 23 critically ill infants younger than 12 months who had no clear diagnosis after standard clinical work-ups underwent rapid, targeted genomics, with 7 receiving a genetic diagnosis. The median turnaround time was 12 days, falling from roughly 3 weeks at the beginning of the study to a maximum of 8 days by the end of the study.
Compound heterozygous mutations in the EPG5, RMND1, and EIF2B5 genes allowed for diagnoses of Vici syndrome, combined oxidative phosphorylation deficiency-11, and vanishing white matter, respectively. Homozygous mutations in the KLHL41, GFER, and GLB1 genes allowed for diagnoses of nemaline myopathy, progressive mitochondrial myopathy, and GM1-gangliosidosis, respectively. In addition, a 1p36.33p36.32 microdeletion was discovered in an infant with cardiomyopathy.
“The clinical relevance of rapid genome diagnostics lies in the fact that these results can be used in the clinical decisions made in caring for critically ill children in ICUs, in better genetic counseling of the parents, and in guiding their future reproductive choices,” the investigators noted.
Find the full study in Pediatrics (2017 Sep 22. doi: 10.1542/ peds.2016-2854).
FROM PEDIATRICS
FDA approves first duodenoscope with disposable distal cap
, according to an FDA press release.
A disposable distal cap will improve the ability to clean and reprocess the duodenoscope. Without being thoroughly cleaned and disinfected, contaminated tissue can remain and potentially can be transmitted to other patients.
A previous version of the Pentax duodenoscope, the ED-3490TK, was subject to a January 2017 FDA Safety Alert, because of the potential for cracks and gaps to develop in the adhesive sealing the duodenoscope’s distal cap.
, according to an FDA press release.
A disposable distal cap will improve the ability to clean and reprocess the duodenoscope. Without being thoroughly cleaned and disinfected, contaminated tissue can remain and potentially can be transmitted to other patients.
A previous version of the Pentax duodenoscope, the ED-3490TK, was subject to a January 2017 FDA Safety Alert, because of the potential for cracks and gaps to develop in the adhesive sealing the duodenoscope’s distal cap.
, according to an FDA press release.
A disposable distal cap will improve the ability to clean and reprocess the duodenoscope. Without being thoroughly cleaned and disinfected, contaminated tissue can remain and potentially can be transmitted to other patients.
A previous version of the Pentax duodenoscope, the ED-3490TK, was subject to a January 2017 FDA Safety Alert, because of the potential for cracks and gaps to develop in the adhesive sealing the duodenoscope’s distal cap.
Clinical trial: Understanding the Genetic Predisposition to the Development of Primary Biliary Cirrhosis
Understanding the Genetic Predisposition to the Development of Primary Biliary Cirrhosis is an observational study recruiting people with a history of PBC and their family members.
The trial will investigate whether or not there is a genetic factor in the development of PBC. Blood and stool samples will be taken from PBC patients and family members of PBC patients and analyzed. If a genetic component is discovered, it will add to current knowledge of how PBC and other adult chronic cholestatic liver diseases develop, as well as suggest new approaches for prevention, diagnosis, and treatment.
Individuals will be included in the study if they are aged 18-90 years old and have a history of PBC or if they are first-degree relatives of someone with PBC. Patients with PBC who have undergone a liver transplant are not excluded.
The primary outcome measure of the study is the mapping of genes that may make patients susceptible to adult chronic cholestatic liver diseases such as PBC.
The study will be completed in December 2025. About 1,500 people are expected to be included in the final analysis.
Find more information at the study page on Clinicaltrials.gov.
Understanding the Genetic Predisposition to the Development of Primary Biliary Cirrhosis is an observational study recruiting people with a history of PBC and their family members.
The trial will investigate whether or not there is a genetic factor in the development of PBC. Blood and stool samples will be taken from PBC patients and family members of PBC patients and analyzed. If a genetic component is discovered, it will add to current knowledge of how PBC and other adult chronic cholestatic liver diseases develop, as well as suggest new approaches for prevention, diagnosis, and treatment.
Individuals will be included in the study if they are aged 18-90 years old and have a history of PBC or if they are first-degree relatives of someone with PBC. Patients with PBC who have undergone a liver transplant are not excluded.
The primary outcome measure of the study is the mapping of genes that may make patients susceptible to adult chronic cholestatic liver diseases such as PBC.
The study will be completed in December 2025. About 1,500 people are expected to be included in the final analysis.
Find more information at the study page on Clinicaltrials.gov.
Understanding the Genetic Predisposition to the Development of Primary Biliary Cirrhosis is an observational study recruiting people with a history of PBC and their family members.
The trial will investigate whether or not there is a genetic factor in the development of PBC. Blood and stool samples will be taken from PBC patients and family members of PBC patients and analyzed. If a genetic component is discovered, it will add to current knowledge of how PBC and other adult chronic cholestatic liver diseases develop, as well as suggest new approaches for prevention, diagnosis, and treatment.
Individuals will be included in the study if they are aged 18-90 years old and have a history of PBC or if they are first-degree relatives of someone with PBC. Patients with PBC who have undergone a liver transplant are not excluded.
The primary outcome measure of the study is the mapping of genes that may make patients susceptible to adult chronic cholestatic liver diseases such as PBC.
The study will be completed in December 2025. About 1,500 people are expected to be included in the final analysis.
Find more information at the study page on Clinicaltrials.gov.
FDA approves triple-therapy inhaler for COPD
The Food and Drug Administration has approved Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), a triple-therapy inhaler for the treatment of chronic obstructive pulmonary disease (COPD) in adult patients, according to a press release from GlaxoSmithKline and Innoviva.
Trelegy Ellipta combines an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist into an inhaler meant for once-daily use in people with COPD. Chronic bronchitis and/or emphysema patients are also indicated for treatment. The FDA-approved dosage is 100 mcg of fluticasone furoate, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol.
“This approval represents a significant therapeutic convenience for those appropriate patients already on Breo Ellipta, that require additional bronchodilation or for those patients already on a combination of Breo Ellipta and Incruse Ellipta,” Mike Aguiar, CEO of Innoviva said in the press release.
In results supporting the FDA approval, the IMPACT study, a 52-week phase 3 clinical trial including 10,355 COPD patients sponsored by GSK, found that patients receiving Trelegy Ellipta experienced a 25% reduction in moderate to severe exacerbations compared to patients receiving Anoro Ellipta, and a 15% reduction in moderate to severe exacerbations, compared with patients receiving Relvar/Breo Ellipta. Change from baseline FEV1, change from baseline scores on the St George’s Respiratory Questionnaire, and time to first moderate/severe COPD exacerbation also were improved in the Trelegy Ellipta study group compared to the others.
“This is the first study to report a comparison of a single inhaler triple therapy with two dual therapies, providing much needed clinical evidence about the ability of a single inhaler triple therapy to reduce exacerbations,” Patrick Vallance, President of R&D at GSK, noted in a press release announcing the results of the IMPACT study.
The Food and Drug Administration has approved Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), a triple-therapy inhaler for the treatment of chronic obstructive pulmonary disease (COPD) in adult patients, according to a press release from GlaxoSmithKline and Innoviva.
Trelegy Ellipta combines an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist into an inhaler meant for once-daily use in people with COPD. Chronic bronchitis and/or emphysema patients are also indicated for treatment. The FDA-approved dosage is 100 mcg of fluticasone furoate, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol.
“This approval represents a significant therapeutic convenience for those appropriate patients already on Breo Ellipta, that require additional bronchodilation or for those patients already on a combination of Breo Ellipta and Incruse Ellipta,” Mike Aguiar, CEO of Innoviva said in the press release.
In results supporting the FDA approval, the IMPACT study, a 52-week phase 3 clinical trial including 10,355 COPD patients sponsored by GSK, found that patients receiving Trelegy Ellipta experienced a 25% reduction in moderate to severe exacerbations compared to patients receiving Anoro Ellipta, and a 15% reduction in moderate to severe exacerbations, compared with patients receiving Relvar/Breo Ellipta. Change from baseline FEV1, change from baseline scores on the St George’s Respiratory Questionnaire, and time to first moderate/severe COPD exacerbation also were improved in the Trelegy Ellipta study group compared to the others.
“This is the first study to report a comparison of a single inhaler triple therapy with two dual therapies, providing much needed clinical evidence about the ability of a single inhaler triple therapy to reduce exacerbations,” Patrick Vallance, President of R&D at GSK, noted in a press release announcing the results of the IMPACT study.
The Food and Drug Administration has approved Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), a triple-therapy inhaler for the treatment of chronic obstructive pulmonary disease (COPD) in adult patients, according to a press release from GlaxoSmithKline and Innoviva.
Trelegy Ellipta combines an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist into an inhaler meant for once-daily use in people with COPD. Chronic bronchitis and/or emphysema patients are also indicated for treatment. The FDA-approved dosage is 100 mcg of fluticasone furoate, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol.
“This approval represents a significant therapeutic convenience for those appropriate patients already on Breo Ellipta, that require additional bronchodilation or for those patients already on a combination of Breo Ellipta and Incruse Ellipta,” Mike Aguiar, CEO of Innoviva said in the press release.
In results supporting the FDA approval, the IMPACT study, a 52-week phase 3 clinical trial including 10,355 COPD patients sponsored by GSK, found that patients receiving Trelegy Ellipta experienced a 25% reduction in moderate to severe exacerbations compared to patients receiving Anoro Ellipta, and a 15% reduction in moderate to severe exacerbations, compared with patients receiving Relvar/Breo Ellipta. Change from baseline FEV1, change from baseline scores on the St George’s Respiratory Questionnaire, and time to first moderate/severe COPD exacerbation also were improved in the Trelegy Ellipta study group compared to the others.
“This is the first study to report a comparison of a single inhaler triple therapy with two dual therapies, providing much needed clinical evidence about the ability of a single inhaler triple therapy to reduce exacerbations,” Patrick Vallance, President of R&D at GSK, noted in a press release announcing the results of the IMPACT study.
Aptiom approved for pediatric partial-onset seizures
The Food and Drug Administration has approved Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in children aged 4-17 years, according to an announcement from Sunovion Pharmaceuticals.
The approval was based on results of three clinical trials where eslicarbazepine was shown to be safe and well tolerated in pediatric populations. The efficacy of eslicarbazepine has been illustrated in clinical trials in adult populations, and data were extrapolated to support usage in pediatric patients. Eslicarbazepine has previously been approved to treat partial-onset seizures in adults.
Pediatric dosing of eslicarbazepine is based on weight, and the tablets, available in 200-mg, 400-mg, 600-mg, and 800-mg strengths, can be taken whole or crushed, with or without food, according to the prescribing information.
“The unpredictable nature of seizures can be disruptive in the lives of these young people and their families, friends, and community. It is important that physicians have additional treatment options that address patient needs,” Steven Wolf, MD, director of pediatric epilepsy at Mount Sinai Health System, said in the announcement.
The Food and Drug Administration has approved Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in children aged 4-17 years, according to an announcement from Sunovion Pharmaceuticals.
The approval was based on results of three clinical trials where eslicarbazepine was shown to be safe and well tolerated in pediatric populations. The efficacy of eslicarbazepine has been illustrated in clinical trials in adult populations, and data were extrapolated to support usage in pediatric patients. Eslicarbazepine has previously been approved to treat partial-onset seizures in adults.
Pediatric dosing of eslicarbazepine is based on weight, and the tablets, available in 200-mg, 400-mg, 600-mg, and 800-mg strengths, can be taken whole or crushed, with or without food, according to the prescribing information.
“The unpredictable nature of seizures can be disruptive in the lives of these young people and their families, friends, and community. It is important that physicians have additional treatment options that address patient needs,” Steven Wolf, MD, director of pediatric epilepsy at Mount Sinai Health System, said in the announcement.
The Food and Drug Administration has approved Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in children aged 4-17 years, according to an announcement from Sunovion Pharmaceuticals.
The approval was based on results of three clinical trials where eslicarbazepine was shown to be safe and well tolerated in pediatric populations. The efficacy of eslicarbazepine has been illustrated in clinical trials in adult populations, and data were extrapolated to support usage in pediatric patients. Eslicarbazepine has previously been approved to treat partial-onset seizures in adults.
Pediatric dosing of eslicarbazepine is based on weight, and the tablets, available in 200-mg, 400-mg, 600-mg, and 800-mg strengths, can be taken whole or crushed, with or without food, according to the prescribing information.
“The unpredictable nature of seizures can be disruptive in the lives of these young people and their families, friends, and community. It is important that physicians have additional treatment options that address patient needs,” Steven Wolf, MD, director of pediatric epilepsy at Mount Sinai Health System, said in the announcement.
Clinical trial: Complex VHR using biologic or synthetic mesh
The Study Comparing the Efficacy, Safety, and Cost of a Permanent, Synthetic Prosthetic Versus a Biologic Prosthetic in the One-Stage Repair of Ventral Hernias in Clean and Contaminated Wounds is an interventional trial currently recruiting patients with ventral hernias.
The trial will compare results of ventral hernia repair in patients who have received a biologic mesh made from pig skin with those who received a synthetic mesh made in a laboratory. Both study groups will include patients with and without infection near the hernia. Synthetic mesh is hypothesized to have a higher rate of early postoperative infection, while biologic mesh is hypothesized to have a higher rate of recurrence.
Patients will be included in the trial if they have a ventral hernia; are older than 21 years; are not pregnant; and have no allergic, religious, or ethical objections to polypropylene or porcine prosthetics. Reasons for exclusion include severe malnutrition, pre-existing parenchymal liver disease, immunocompromisation, and refractory ascites.
The primary outcome measure is recurrence within 24 months of surgery, and the secondary outcome measure is wound events within 24 months of surgery. Other outcome measures include early postoperative complications within 1 month of surgery and quality of life, pain, activity level, and overall cost with 24 months of surgery.
The study will end in June 2019. About 330 people are expected to be included in the final analysis.
Find more information at the study page on Clinicaltrials.gov.
The Study Comparing the Efficacy, Safety, and Cost of a Permanent, Synthetic Prosthetic Versus a Biologic Prosthetic in the One-Stage Repair of Ventral Hernias in Clean and Contaminated Wounds is an interventional trial currently recruiting patients with ventral hernias.
The trial will compare results of ventral hernia repair in patients who have received a biologic mesh made from pig skin with those who received a synthetic mesh made in a laboratory. Both study groups will include patients with and without infection near the hernia. Synthetic mesh is hypothesized to have a higher rate of early postoperative infection, while biologic mesh is hypothesized to have a higher rate of recurrence.
Patients will be included in the trial if they have a ventral hernia; are older than 21 years; are not pregnant; and have no allergic, religious, or ethical objections to polypropylene or porcine prosthetics. Reasons for exclusion include severe malnutrition, pre-existing parenchymal liver disease, immunocompromisation, and refractory ascites.
The primary outcome measure is recurrence within 24 months of surgery, and the secondary outcome measure is wound events within 24 months of surgery. Other outcome measures include early postoperative complications within 1 month of surgery and quality of life, pain, activity level, and overall cost with 24 months of surgery.
The study will end in June 2019. About 330 people are expected to be included in the final analysis.
Find more information at the study page on Clinicaltrials.gov.
The Study Comparing the Efficacy, Safety, and Cost of a Permanent, Synthetic Prosthetic Versus a Biologic Prosthetic in the One-Stage Repair of Ventral Hernias in Clean and Contaminated Wounds is an interventional trial currently recruiting patients with ventral hernias.
The trial will compare results of ventral hernia repair in patients who have received a biologic mesh made from pig skin with those who received a synthetic mesh made in a laboratory. Both study groups will include patients with and without infection near the hernia. Synthetic mesh is hypothesized to have a higher rate of early postoperative infection, while biologic mesh is hypothesized to have a higher rate of recurrence.
Patients will be included in the trial if they have a ventral hernia; are older than 21 years; are not pregnant; and have no allergic, religious, or ethical objections to polypropylene or porcine prosthetics. Reasons for exclusion include severe malnutrition, pre-existing parenchymal liver disease, immunocompromisation, and refractory ascites.
The primary outcome measure is recurrence within 24 months of surgery, and the secondary outcome measure is wound events within 24 months of surgery. Other outcome measures include early postoperative complications within 1 month of surgery and quality of life, pain, activity level, and overall cost with 24 months of surgery.
The study will end in June 2019. About 330 people are expected to be included in the final analysis.
Find more information at the study page on Clinicaltrials.gov.
SUMMARY FROM CLINICALTRIALS.GOV
CREST syndrome and PBC are often associated
Primary biliary cholangitis can be associated with limited cutaneous systemic sclerosis (CREST syndrome), according to a clinical communication to the editor from Amirali Kiyani, MD, and Shannon Ursu, MD.
In their case study, a 56-year-old woman presented to the emergency department with a syncopal episode. The patient’s medical history included primary biliary cholangitis (PBC), breast cancer status post lumpectomy and chemoradiation, gastroesophageal reflux disease, Raynaud’s phenomenon, and multiple episodes of gastrointestinal bleeding. Vital signs were normal at the time of admission.
After examination and testing, the patient was found to have low serum complement levels and elevated C-reactive protein. Anti-Scl 70 antibody, SSA, and SSB antibody were negative, and thyroid-stimulating hormone and antitransglutaminase antibodies were normal. No evidence of heart failure or pulmonary hypertension was seen in a transthoracic echocardiogram, and the patient was diagnosed with limited cutaneous systemic sclerosis.
Sjögren’s syndrome and autoimmune thyroiditis are the most common extrahepatic autoimmune disorders associated with PBC, but PBC is associated with CREST syndrome in 1%-6% of cases, according to the literature the investigators reviewed, they said.
“Primary biliary cholangitis is commonly associated with extrahepatic autoimmune disorders such as limited cutaneous systemic sclerosis. … Screening for these autoimmune disorders can prevent further morbidity and keep patients viable candidates for liver transplant,” they concluded.
Find the full clinical communication in the American Journal of Medicine (doi: 10.1016/j.amjmed.2017.05.019).
This story was updated on 9/13/2017.
Primary biliary cholangitis can be associated with limited cutaneous systemic sclerosis (CREST syndrome), according to a clinical communication to the editor from Amirali Kiyani, MD, and Shannon Ursu, MD.
In their case study, a 56-year-old woman presented to the emergency department with a syncopal episode. The patient’s medical history included primary biliary cholangitis (PBC), breast cancer status post lumpectomy and chemoradiation, gastroesophageal reflux disease, Raynaud’s phenomenon, and multiple episodes of gastrointestinal bleeding. Vital signs were normal at the time of admission.
After examination and testing, the patient was found to have low serum complement levels and elevated C-reactive protein. Anti-Scl 70 antibody, SSA, and SSB antibody were negative, and thyroid-stimulating hormone and antitransglutaminase antibodies were normal. No evidence of heart failure or pulmonary hypertension was seen in a transthoracic echocardiogram, and the patient was diagnosed with limited cutaneous systemic sclerosis.
Sjögren’s syndrome and autoimmune thyroiditis are the most common extrahepatic autoimmune disorders associated with PBC, but PBC is associated with CREST syndrome in 1%-6% of cases, according to the literature the investigators reviewed, they said.
“Primary biliary cholangitis is commonly associated with extrahepatic autoimmune disorders such as limited cutaneous systemic sclerosis. … Screening for these autoimmune disorders can prevent further morbidity and keep patients viable candidates for liver transplant,” they concluded.
Find the full clinical communication in the American Journal of Medicine (doi: 10.1016/j.amjmed.2017.05.019).
This story was updated on 9/13/2017.
Primary biliary cholangitis can be associated with limited cutaneous systemic sclerosis (CREST syndrome), according to a clinical communication to the editor from Amirali Kiyani, MD, and Shannon Ursu, MD.
In their case study, a 56-year-old woman presented to the emergency department with a syncopal episode. The patient’s medical history included primary biliary cholangitis (PBC), breast cancer status post lumpectomy and chemoradiation, gastroesophageal reflux disease, Raynaud’s phenomenon, and multiple episodes of gastrointestinal bleeding. Vital signs were normal at the time of admission.
After examination and testing, the patient was found to have low serum complement levels and elevated C-reactive protein. Anti-Scl 70 antibody, SSA, and SSB antibody were negative, and thyroid-stimulating hormone and antitransglutaminase antibodies were normal. No evidence of heart failure or pulmonary hypertension was seen in a transthoracic echocardiogram, and the patient was diagnosed with limited cutaneous systemic sclerosis.
Sjögren’s syndrome and autoimmune thyroiditis are the most common extrahepatic autoimmune disorders associated with PBC, but PBC is associated with CREST syndrome in 1%-6% of cases, according to the literature the investigators reviewed, they said.
“Primary biliary cholangitis is commonly associated with extrahepatic autoimmune disorders such as limited cutaneous systemic sclerosis. … Screening for these autoimmune disorders can prevent further morbidity and keep patients viable candidates for liver transplant,” they concluded.
Find the full clinical communication in the American Journal of Medicine (doi: 10.1016/j.amjmed.2017.05.019).
This story was updated on 9/13/2017.
FROM THE AMERICAN JOURNAL OF MEDICINE
No obvious choice for treating pruritus in PBC patients
While multiple options exist for the treatment of pruritus in patients with primary biliary cholangitis (PBC), none have compelling evidence regarding their long-term efficacy and safety, according to a narrative review of literature by Hirsh D. Trivedi, MD, and associates.
There are four treatments commonly used for treating pruritus in PBC patients: bile acid–binding resins, rifampicin, opioid antagonists, and sertraline. In the cases of bile acid–binding resins, rifampicin, and opioid antagonists, significant side effects and a lack of proof of long-term efficacy prevent the treatments from standing out. Sertraline seems to have no significant side effects, but research is lacking, and further investigation is required.
Several experimental treatments for refractory pruritus also exist: These include phototherapy, plasmapheresis, albumin dialysis, nasobiliary drainage, ileal bile acid transporter–inhibitors, methotrexate and colchicine, and fibrates. In extreme cases, liver transplant can also be utilized to reduce pruritus symptoms.
“Our ongoing learning [about] this multifaceted symptom will hopefully lead to the development of more effective therapies and improve the quality of life for patients with primary biliary cholangitis,” the investigators concluded.
Find the full narrative review in the American Journal of Medicine (doi: 10.1016/j.amjmed.2017.01.037).
While multiple options exist for the treatment of pruritus in patients with primary biliary cholangitis (PBC), none have compelling evidence regarding their long-term efficacy and safety, according to a narrative review of literature by Hirsh D. Trivedi, MD, and associates.
There are four treatments commonly used for treating pruritus in PBC patients: bile acid–binding resins, rifampicin, opioid antagonists, and sertraline. In the cases of bile acid–binding resins, rifampicin, and opioid antagonists, significant side effects and a lack of proof of long-term efficacy prevent the treatments from standing out. Sertraline seems to have no significant side effects, but research is lacking, and further investigation is required.
Several experimental treatments for refractory pruritus also exist: These include phototherapy, plasmapheresis, albumin dialysis, nasobiliary drainage, ileal bile acid transporter–inhibitors, methotrexate and colchicine, and fibrates. In extreme cases, liver transplant can also be utilized to reduce pruritus symptoms.
“Our ongoing learning [about] this multifaceted symptom will hopefully lead to the development of more effective therapies and improve the quality of life for patients with primary biliary cholangitis,” the investigators concluded.
Find the full narrative review in the American Journal of Medicine (doi: 10.1016/j.amjmed.2017.01.037).
While multiple options exist for the treatment of pruritus in patients with primary biliary cholangitis (PBC), none have compelling evidence regarding their long-term efficacy and safety, according to a narrative review of literature by Hirsh D. Trivedi, MD, and associates.
There are four treatments commonly used for treating pruritus in PBC patients: bile acid–binding resins, rifampicin, opioid antagonists, and sertraline. In the cases of bile acid–binding resins, rifampicin, and opioid antagonists, significant side effects and a lack of proof of long-term efficacy prevent the treatments from standing out. Sertraline seems to have no significant side effects, but research is lacking, and further investigation is required.
Several experimental treatments for refractory pruritus also exist: These include phototherapy, plasmapheresis, albumin dialysis, nasobiliary drainage, ileal bile acid transporter–inhibitors, methotrexate and colchicine, and fibrates. In extreme cases, liver transplant can also be utilized to reduce pruritus symptoms.
“Our ongoing learning [about] this multifaceted symptom will hopefully lead to the development of more effective therapies and improve the quality of life for patients with primary biliary cholangitis,” the investigators concluded.
Find the full narrative review in the American Journal of Medicine (doi: 10.1016/j.amjmed.2017.01.037).
FROM THE AMERICAN JOURNAL OF MEDICINE