Same-admission versus interval cholecystectomy for mild gallstone pancreatitis (PONCHO): a multicentre randomised controlled trial

• Published in: The Lancet (British edition) 2015-09, Vol.386 (10000), p.1261-1268
• Main Authors: da Costa, David W, MD, Bouwense, Stefan A, MD, Schepers, Nicolien J, MD, Besselink, Marc G, PhD, van Santvoort, Hjalmar C, PhD, van Brunschot, Sandra, MD, Bakker, Olaf J, PhD, Bollen, Thomas L, MD, Dejong, Cornelis H, Prof, van Goor, Harry, Prof, Boermeester, Marja A, Prof, Bruno, Marco J, Prof, van Eijck, Casper H, Prof, Timmer, Robin, PhD, Weusten, Bas L, Prof, Consten, Esther C, PhD, Brink, Menno A, PhD, Spanier, B W Marcel, PhD, Bilgen, Ernst Jan Spillenaar, PhD, Nieuwenhuijs, Vincent B, PhD, Hofker, H Sijbrand, PhD, Rosman, Camiel, PhD, Voorburg, Annet M, MD, Bosscha, Koop, PhD, van Duijvendijk, Peter, PhD, Gerritsen, Jos J, PhD, Heisterkamp, Joos, PhD, de Hingh, Ignace H, PhD, Witteman, Ben J, Prof, Kruyt, Philip M, MD, Scheepers, Joris J, PhD, Molenaar, I Quintus, PhD, Schaapherder, Alexander F, PhD, Manusama, Eric R, PhD, van der Waaij, Laurens A, PhD, van Unen, Jacco, MD, Dijkgraaf, Marcel G, PhD, van Ramshorst, Bert, PhD, Gooszen, Hein G, Prof, Boerma, Djamila, Dr
• Format: Article
• Language: English
• Subjects: Adult; Aged; Alcohols; Analgesics; Bile; Bile ducts; Bleeding; C-reactive protein; Calculi; Cholangitis; Cholecystectomy; Cholecystectomy - methods; Cholecystitis; Clinical trials; Colic; Digestive system diseases; Endoscopy; Evidence-based medicine; Family medical history; Female; Gallbladder diseases; Gallstones; Gallstones - complications; Gallstones - surgery; Gastroenterology; Hospitals; Humans; Internal Medicine; Leakage; Male; Middle Aged; Mortality; Opioids; Pancreas; Pancreatitis; Pancreatitis - etiology; Pancreatitis - surgery; Patient admissions; Patients; Randomization; Risk; Safety; Studies; Surgery; Surgical outcomes; Systematic review; Systemic diseases; Time Factors; Treatment Outcome
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(15)00274-3

Summary Background In patients with mild gallstone pancreatitis, cholecystectomy during the same hospital admission might reduce the risk of recurrent gallstone-related complications, compared with the more commonly used strategy of interval cholecystectomy. However, evidence to support same-admission cholecystectomy is poor, and concerns exist about an increased risk of cholecystectomy-related complications with this approach. In this study, we aimed to compare same-admission and interval cholecystectomy, with the hypothesis that same-admission cholecystectomy would reduce the risk of recurrent gallstone-related complications without increasing the difficulty of surgery. Methods For this multicentre, parallel-group, assessor-masked, randomised controlled superiority trial, inpatients recovering from mild gallstone pancreatitis at 23 hospitals in the Netherlands (with hospital discharge foreseen within 48 h) were assessed for eligibility. Adult patients (aged ≥18 years) were eligible for randomisation if they had a serum C-reactive protein concentration less than 100 mg/L, no need for opioid analgesics, and could tolerate a normal oral diet. Patients with American Society of Anesthesiologists (ASA) class III physical status who were older than 75 years of age, all ASA class IV patients, those with chronic pancreatitis, and those with ongoing alcohol misuse were excluded. A central study coordinator randomly assigned eligible patients (1:1) by computer-based randomisation, with varying block sizes of two and four patients, to cholecystectomy within 3 days of randomisation (same-admission cholecystectomy) or to discharge and cholecystectomy 25–30 days after randomisation (interval cholecystectomy). Randomisation was stratified by centre and by whether or not endoscopic sphincterotomy had been done. Neither investigators nor participants were masked to group assignment. The primary endpoint was a composite of readmission for recurrent gallstone-related complications (pancreatitis, cholangitis, cholecystitis, choledocholithiasis needing endoscopic intervention, or gallstone colic) or mortality within 6 months after randomisation, analysed by intention to treat. The trial was designed to reduce the incidence of the primary endpoint from 8% in the interval group to 1% in the same-admission group. Safety endpoints included bile duct leakage and other complications necessitating re-intervention. This trial is registered with Current Controlled Trials, number ISRCT