Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial
<p>Abstract</p> <p>Background</p> <p>After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after...
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| Format: | Article |
| Language: | English |
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BMC
2012-11-01
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| Series: | Trials |
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| Online Access: | http://www.trialsjournal.com/content/13/1/225 |
| _version_ | 1818565135049949184 |
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| author | Bouwense Stefan A Besselink Marc G van Brunschot Sandra Bakker Olaf J van Santvoort Hjalmar C Schepers Nicolien J Boermeester Marja A Bollen Thomas L Bosscha Koop Brink Menno A Bruno Marco J Consten Esther C Dejong Cornelis H van Duijvendijk Peter van Eijck Casper H Gerritsen Jos J van Goor Harry Heisterkamp Joos de Hingh Ignace H Kruyt Philip M Molenaar I Nieuwenhuijs Vincent B Rosman Camiel Schaapherder Alexander F Scheepers Joris J Spanier Marcel BW Timmer Robin Weusten Bas L Witteman Ben J van Ramshorst Bert Gooszen Hein G Boerma Djamila |
| author_facet | Bouwense Stefan A Besselink Marc G van Brunschot Sandra Bakker Olaf J van Santvoort Hjalmar C Schepers Nicolien J Boermeester Marja A Bollen Thomas L Bosscha Koop Brink Menno A Bruno Marco J Consten Esther C Dejong Cornelis H van Duijvendijk Peter van Eijck Casper H Gerritsen Jos J van Goor Harry Heisterkamp Joos de Hingh Ignace H Kruyt Philip M Molenaar I Nieuwenhuijs Vincent B Rosman Camiel Schaapherder Alexander F Scheepers Joris J Spanier Marcel BW Timmer Robin Weusten Bas L Witteman Ben J van Ramshorst Bert Gooszen Hein G Boerma Djamila |
| author_sort | Bouwense Stefan A |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy.</p> <p>Methods/Design</p> <p>PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy), and uncomplicated biliary colics) occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs.</p> <p>Discussion</p> <p>The PONCHO trial is designed to show that early laparoscopic cholecystectomy (within 72 hours) reduces the combined endpoint of mortality and re-admissions for biliary events as compared with interval laparoscopic cholecystectomy (between 25 and 30 days) after recovery of a first episode of mild biliary pancreatitis.</p> <p>Trial registration</p> <p>Current Controlled Trials: ISRCTN72764151</p> |
| first_indexed | 2024-12-14T01:37:20Z |
| format | Article |
| id | doaj.art-406d28cc66034008a533a7ad8af94856 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T01:37:20Z |
| publishDate | 2012-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-406d28cc66034008a533a7ad8af948562022-12-21T23:21:51ZengBMCTrials1745-62152012-11-0113122510.1186/1745-6215-13-225Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trialBouwense Stefan ABesselink Marc Gvan Brunschot SandraBakker Olaf Jvan Santvoort Hjalmar CSchepers Nicolien JBoermeester Marja ABollen Thomas LBosscha KoopBrink Menno ABruno Marco JConsten Esther CDejong Cornelis Hvan Duijvendijk Petervan Eijck Casper HGerritsen Jos Jvan Goor HarryHeisterkamp Joosde Hingh Ignace HKruyt Philip MMolenaar INieuwenhuijs Vincent BRosman CamielSchaapherder Alexander FScheepers Joris JSpanier Marcel BWTimmer RobinWeusten Bas LWitteman Ben Jvan Ramshorst BertGooszen Hein GBoerma Djamila<p>Abstract</p> <p>Background</p> <p>After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy.</p> <p>Methods/Design</p> <p>PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy), and uncomplicated biliary colics) occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs.</p> <p>Discussion</p> <p>The PONCHO trial is designed to show that early laparoscopic cholecystectomy (within 72 hours) reduces the combined endpoint of mortality and re-admissions for biliary events as compared with interval laparoscopic cholecystectomy (between 25 and 30 days) after recovery of a first episode of mild biliary pancreatitis.</p> <p>Trial registration</p> <p>Current Controlled Trials: ISRCTN72764151</p>http://www.trialsjournal.com/content/13/1/225Acute pancreatitisGallstonesTrialCommon bile ductCholecystitisEndoscopic retrograde cholangiopancreaticographySurgeryCholecystectomyTimingMortality |
| spellingShingle | Bouwense Stefan A Besselink Marc G van Brunschot Sandra Bakker Olaf J van Santvoort Hjalmar C Schepers Nicolien J Boermeester Marja A Bollen Thomas L Bosscha Koop Brink Menno A Bruno Marco J Consten Esther C Dejong Cornelis H van Duijvendijk Peter van Eijck Casper H Gerritsen Jos J van Goor Harry Heisterkamp Joos de Hingh Ignace H Kruyt Philip M Molenaar I Nieuwenhuijs Vincent B Rosman Camiel Schaapherder Alexander F Scheepers Joris J Spanier Marcel BW Timmer Robin Weusten Bas L Witteman Ben J van Ramshorst Bert Gooszen Hein G Boerma Djamila Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial Trials Acute pancreatitis Gallstones Trial Common bile duct Cholecystitis Endoscopic retrograde cholangiopancreaticography Surgery Cholecystectomy Timing Mortality |
| title | Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial |
| title_full | Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial |
| title_fullStr | Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial |
| title_full_unstemmed | Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial |
| title_short | Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial |
| title_sort | pancreatitis of biliary origin optimal timing of cholecystectomy poncho trial study protocol for a randomized controlled trial |
| topic | Acute pancreatitis Gallstones Trial Common bile duct Cholecystitis Endoscopic retrograde cholangiopancreaticography Surgery Cholecystectomy Timing Mortality |
| url | http://www.trialsjournal.com/content/13/1/225 |
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