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Open Access 01-12-2012 | Study protocol

Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial

Authors: Stefan A Bouwense, Marc G Besselink, Sandra van Brunschot, Olaf J Bakker, Hjalmar C van Santvoort, Nicolien J Schepers, Marja A Boermeester, Thomas L Bollen, Koop Bosscha, Menno A Brink, Marco J Bruno, Esther C Consten, Cornelis H Dejong, Peter van Duijvendijk, Casper H van Eijck, Jos J Gerritsen, Harry van Goor, Joos Heisterkamp, Ignace H de Hingh, Philip M Kruyt, I Quintus Molenaar, Vincent B Nieuwenhuijs, Camiel Rosman, Alexander F Schaapherder, Joris J Scheepers, Marcel BW Spanier, Robin Timmer, Bas L Weusten, Ben J Witteman, Bert van Ramshorst, Hein G Gooszen, Djamila Boerma, for the Dutch Pancreatitis Study Group

Published in: Trials | Issue 1/2012

Abstract

Background

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.

Methods/Design

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.

Discussion

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.

Trial registration

Current Controlled Trials: ISRCTN72764151

Available only for authorised users

Shaheen NJ, Hansen RA, Morgan DR, Gangarosa LM, Ringel Y, Thiny MT, Russo MW, Sandler RS: The burden of gastrointestinal and liver diseases, 2006. Am J Gastroenterol. 2006, 101: 2128-2138. 10.1111/j.1572-0241.2006.00723.x.CrossRefPubMed

Fagenholz PJ, Fernandez-del Castillo C, Harris NS, Pelletier AJ, Camargo CA: Direct medical costs of acute pancreatitis hospitalizations in the United States. Pancreas. 2007, 35: 302-307. 10.1097/MPA.0b013e3180cac24b.CrossRefPubMed

Yadav D, Lowenfels AB: Trends in the epidemiology of the first attack of acute pancreatitis: a systematic review. Pancreas. 2006, 33: 323-330. 10.1097/01.mpa.0000236733.31617.52.CrossRefPubMed

UK Working Party on Acute Pancreatitis: UK guidelines for the management of acute pancreatitis. Gut. 2005, 54 (Suppl 3): iii1-iii9.

Forsmark CE, Baillie J: AGA institute technical review on acute pancreatitis. Gastroenterology. 2007, 132: 2022-2044. 10.1053/j.gastro.2007.03.065.CrossRefPubMed

Banks PA, Freeman ML: Practice guidelines in acute pancreatitis. Am J Gastroenterol. 2006, 101: 2379-2400. 10.1111/j.1572-0241.2006.00856.x.CrossRefPubMed

Uhl W, Warshaw A, Imrie C, Bassi C, McKay CJ, Lankisch PG, Carter R, Di Magno E, Banks PA, Whitcomb DC, Dervenis C, Ulrich CD, Satake K, Ghaneh P, Hartwig W, Werner J, McEntee G, Neoptolemos JP, Büchler MW, International Association of Pancreatology: IAP Guidelines for the Surgical Management of Acute Pancreatitis. Pancreatology. 2002, 2: 565-573. 10.1159/000071269.CrossRefPubMed

Gullo L, Migliori M, Pezzilli R, Olah A, Farkas G, Levy P, Arvanitakis C, Lankisch P, Beger H: An update on recurrent acute pancreatitis: data from five European countries. Am J Gastroenterol. 2002, 97: 1959-1962. 10.1111/j.1572-0241.2002.05907.x.CrossRefPubMed

Nealon WH, Bawduniak J, Walser EM: Appropriate timing of cholecystectomy in patients who present with moderate to severe gallstone-associated acute pancreatitis with peripancreatic fluid collections. Ann Surg. 2004, 239: 741-749. 10.1097/01.sla.0000128688.97556.94.CrossRefPubMedPubMedCentral

10.

Nederlandse Internisten Vereniging: Richtlijn Acute Pancreatitis.http://www.pancreatitis.nl,

11.

Toouli J, Brooke-Smith M, Bassi C, Carr-Locke D, Telford J, Freeny P, Imrie C, Tandon R: Guidelines for the management of acute pancreatitis. J Gastroenterol Hepatol. 2002, 17 (Suppl 1): 15-39.CrossRef

12.

Lankisch PG, Weber-Dany B, Lerch MM: Clinical perspectives in pancreatology: compliance with acute pancreatitis guidelines in Germany. Pancreatology. 2005, 5: 591-593. 10.1159/000087501.CrossRefPubMed

13.

Monkhouse SJ, Court EL, Dash I, Coombs NJ: Two-week target for laparoscopic cholecystectomy following gallstone pancreatitis is achievable and cost neutral. Br J Surg. 2009, 96: 751-755. 10.1002/bjs.6644.CrossRefPubMed

14.

Nguyen GC, Boudreau H, Jagannath SB: Hospital volume as a predictor for undergoing cholecystectomy after admission for acute biliary pancreatitis. Pancreas. 2010, 39: e42-e47. 10.1097/MPA.0b013e3181bd6387.CrossRefPubMed

15.

Pezzilli R, Uomo G, Gabbrielli A, Zerbi A, Frulloni L, De Rai P, Castoldi L, Cavallini G, Di Carlo V: A prospective multicentre survey on the treatment of acute pancreatitis in Italy. Dig Liver Dis. 2007, 39: 838-846. 10.1016/j.dld.2007.05.014.CrossRefPubMed

16.

Bakker OJ, van Santvoort HC, Hagenaars JC, Besselink MG, Bollen TL, Gooszen HG, Schaapherder AF: Dutch Pancreatitis Study Group: Timing of cholecystectomy after mild biliary pancreatitis. Br J Surg. 2011, 98: 1446-1454. 10.1002/bjs.7587.CrossRefPubMed

17.

van Baal MC, Besselink MG, Bakker OJ, van Santvoort HC, Schaapherder AF, Nieuwenhuijs VB, Gooszen HG, van Ramshorst B, Boerma D: Dutch Pancreatitis Study Group: timing of cholecystectomy after mild biliary pancreatitis: a systematic review. Ann Surg. 2012, 255: 860-866. 10.1097/SLA.0b013e3182507646.CrossRefPubMed

18.

Sinha R: Early laparoscopic cholecystectomy in acute biliary pancreatitis: the optimal choice?. HPB (Oxford). 2008, 10: 332-335. 10.1080/13651820802247078.CrossRef

19.

Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS, Acute Pancreatitis Classification Working Group: Classification of acute pancreatitis—2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2012

20.

van Santvoort HC, Besselink MG, de Vries AC, Boermeester MA, Fischer K, Bollen TL, Cirkel GA, Schaapherder AF, Nieuwenhuijs VB, van Goor H, Dejong CH, van Eijck CH, Witteman BJ, Weusten BL, van Laarhoven CJ, Wahab PJ, Tan AC, Schwartz MP, van der Harst E, Cuesta MA, Siersema PD, Gooszen HG, van Erpecum KJ, Dutch Acute Pancreatitis Study Group: Early endoscopic retrograde cholangiopancreatography in predicted severe acute biliary pancreatitis: a prospective multicenter study. Ann Surg. 2009, 250: 68-75. 10.1097/SLA.0b013e3181a77bb4.CrossRefPubMed

21.

Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ: Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis 904. Cochrane Database Syst Rev. 2006, 4: CD006231-PubMed

22.

Mayumi T, Takada T, Kawarada Y, Nimura Y, Yoshida M, Sekimoto M, Miura F, Wada K, Hirota M, Yamashita Y, Nagino M, Tsuyuguchi T, Tanaka A, Gomi H, Pitt HA: Results of the Tokyo Consensus Meeting Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007, 14: 114-121. 10.1007/s00534-006-1163-8.CrossRefPubMedPubMedCentral

23.

Bergman JJ, van den Brink GR, Rauws EA, de Wit L, Obertop H, Huibregtse K, Tytgat GN, Gouma DJ: Treatment of bile duct lesions after laparoscopic cholecystectomy. Gut. 1996, 38: 141-147. 10.1136/gut.38.1.141.CrossRefPubMedPubMedCentral

24.

Schulz KF, Altman DG, Moher D: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010, 340: c332-10.1136/bmj.c332.CrossRefPubMedPubMedCentral

25.

Ammori BJ, Boreham B, Lewis P, Roberts SA: The biochemical detection of biliary etiology of acute pancreatitis on admission: a revisit in the modern era of biliary imaging. Pancreas. 2003, 26: e32-e35. 10.1097/00006676-200303000-00023.CrossRefPubMed

26.

Levy P, Boruchowicz A, Hastier P, Pariente A, Thevenot T, Frossard JL, Buscail L, Mauvais F, Duchmann JC, Courrier A, Bulois P, Gineston JL, Barthet M, Licht H, O’Toole D, Ruszniewski P: Multicentre prospective evaluation of 213 patients. Pancreatology. 2005, 5: 450-456. 10.1159/000086547.CrossRefPubMed

27.

Tenner S, Dubner H, Steinberg W: Predicting gallstone pancreatitis with laboratory parameters: a meta-analysis. Am J Gastroenterol. 1994, 89: 1863-1866.PubMed

28.

Neoptolemos JP, Carr-Locke DL, London NJ, Bailey IA, James D, Fossard DP: Controlled trial of urgent endoscopic retrograde cholangiopancreatography and endoscopic sphincterotomy versus conservative treatment for acute pancreatitis due to gallstones. Lancet. 1988, 2: 979-983.CrossRefPubMed

29.

Folsch UR, Nitsche R, Ludtke R, Hilgers RA, Creutzfeldt W: Early ERCP and papillotomy compared with conservative treatment for acute biliary pancreatitis. N Engl J Med. 1997, 336: 237-242. 10.1056/NEJM199701233360401.CrossRefPubMed

30.

White IR, Altmann DR, Nanchanal K: Alcohol consumption and mortality: modelling risks for men and women at different ages. BMJ. 2002, 325: 191-194. 10.1136/bmj.325.7357.191.CrossRefPubMedPubMedCentral

31.

van Geenen EJ, van der Peet DL, Mulder CJ, Cuesta MA, Bruno MJ: Recurrent acute biliary pancreatitis: the protective role of cholecystectomy and endoscopic sphincterotomy. Surg Endosc. 2009, 23: 950-956. 10.1007/s00464-009-0339-0.CrossRefPubMed

32.

Strasberg SM, Hertl M, Soper NJ: An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995, 180: 101-125.PubMed

33.

Tonouchi H, Ohmori Y, Kobayashi M, Kusunoki M: Trocar site hernia. Arch Surg. 2004, 139: 1248-1256. 10.1001/archsurg.139.11.1248.CrossRefPubMed

34.

Lange JF, Stassen LPS: Best Practice: De techniek van de laparoscopische cholecystectomie (Critical View of Safety [CVS]; Werkgroep Endoscopische Chirurgie van de Nederlandse Vereniging voor Heelkunde). 2006, 2006

35.

Venneman NG, Besselink MG, Keulemans YC, van Berge-Henegouwen GP, Boermeester MA, Broeders IA, Go PM, van Erpecum KJ: Ursodeoxycholic acid exerts no beneficial effect in patients with symptomatic gallstones awaiting cholecystectomy. Hepatology. 2006, 43: 1276-1283. 10.1002/hep.21182.CrossRefPubMed

36.

van Roijen L, Essink-Bot ML, Koopmanschap MA, Bonsel G, Rutten FF: Labor and health status in economic evaluation of health care. The Health and Labor Questionnaire. Int J Technol Assess Health Care. 1996, 12: 405-415. 10.1017/S0266462300009764.CrossRefPubMed

37.

ToetsingOnline:https://toetsingonline.ccmo.nl,

38.

Besselink MG, van Santvoort HC, Buskens E, Boermeester MA, van Goor H, Timmerman HM, Nieuwenhuijs VB, Bollen TL, van Ramshorst B, Witteman BJ, Rosman C, Ploeg RJ, Brink MA, Schaapherder AF, Dejong CH, Wahab PJ, van Laarhoven CJ, van der Harst E, van Eijck CH, Cuesta MA, Akkermans LM, Gooszen HG, Dutch Acute Pancreatitis Study Group: Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial. Lancet. 2008, 371: 651-659. 10.1016/S0140-6736(08)60207-X.CrossRefPubMed

39.

van Santvoort HC, Besselink MG, Bakker OJ, Hofker HS, Boermeester MA, Dejong CH, van Goor H, Schaapherder AF, van Eijck CH, Bollen TL, van Ramshorst B, Nieuwenhuijs VB, Timmer R, Laméris JS, Kruyt PM, Manusama ER, van der Harst E, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, van Leeuwen MS, Buskens E, Gooszen HG, Dutch Pancreatitis Study Group: A step-up approach or open necrosectomy for necrotizing pancreatitis. N Engl J Med. 2010, 362: 1491-1502. 10.1056/NEJMoa0908821.CrossRefPubMed

40.

Ellenberg SS, Fleming TR, de Mets DL: Data Monitoring Committees in Clinical Trials. 2002, Chichester: WileyCrossRef

41.

Reinders JS, Goud A, Timmer R, Kruyt PM, Witteman BJ, Smakman N, Breumelhof R, Donkervoort SC, Jansen JM, Heisterkamp J, Grubben M, van Ramshorst B, Boerma D: Early laparoscopic cholecystectomy improves outcomes after endoscopic sphincterotomy for choledochocystolithiasis. Gastroenterology. 2010, 138: 2315-2320. 10.1053/j.gastro.2010.02.052.CrossRefPubMed

42.

Hazzan D, Geron N, Golijanin D, Reissman P, Shiloni E: Laparoscopic cholecystectomy in octogenarians. Surg Endosc. 2003, 17: 773-776. 10.1007/s00464-002-8529-z.CrossRefPubMed

43.

Leandros E, Alexakis N, Archontovasilis F, Albanopoulos K, Dardamanis D, Menenakos E, Tsigris C, Giannopoulos A: Outcome analysis of laparoscopic cholecystectomy in patients aged 80 years and older with complicated gallstone disease. J Laparoendosc Adv Surg Tech A. 2007, 17: 731-735. 10.1089/lap.2007.0018.CrossRefPubMed

Title: Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial
Authors: Stefan A Bouwense
Marc G Besselink
Sandra van Brunschot
Olaf J Bakker
Hjalmar C van Santvoort
Nicolien J Schepers
Marja A Boermeester
Thomas L Bollen
Koop Bosscha
Menno A Brink
Marco J Bruno
Esther C Consten
Cornelis H Dejong
Peter van Duijvendijk
Casper H van Eijck
Jos J Gerritsen
Harry van Goor
Joos Heisterkamp
Ignace H de Hingh
Philip M Kruyt
I Quintus Molenaar
Vincent B Nieuwenhuijs
Camiel Rosman
Alexander F Schaapherder
Joris J Scheepers
Marcel BW Spanier
Robin Timmer
Bas L Weusten
Ben J Witteman
Bert van Ramshorst
Hein G Gooszen
Djamila Boerma
for the Dutch Pancreatitis Study Group
Publication date: 01-12-2012
Publisher: BioMed Central
Published in: Trials / Issue 1/2012
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/1745-6215-13-225

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Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial

Abstract

Background

Methods/Design

Discussion

Trial registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration

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