Protocol for a randomized trial of the effect of timing of cholecystectomy during initial admission for predicted mild gallstone pancreatitis at a safety-net hospital

BACKGROUND: There is evidence-based consensus for laparoscopic cholecystectomy during index admission for predicted mild gallstone pancreatitis, defined by the absence of organ failure and of local or systemic complications. However, the optimal timing for surgery within that admission is controversial. Early cholecystectomy may shorten hospital length of stay (LOS) and increase patient satisfaction. Alternatively, it may increase operative difficulty and complications resulting in readmissions. METHODS: This trial is a single-center randomized trial of patients with predicted mild gallstone pancreatitis comparing laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) at index admission within 24 hours of presentation versus after clinical resolution on clinical and patient-reported outcomes (PROs). The primary endpoint is 30-day LOS (hours) after initial presentation, which includes the index admission and readmissions. Secondary outcomes are conversion to open, complications, time from admission to cholecystectomy, initial hospital LOS, number of procedures within 30 days, 30-day readmissions, and PROs (change in Gastrointestinal Quality-of-Life Index). DISCUSSION: The primary goal of this research is to obtain the least biased estimate of effect of timing of cholecystectomy for mild gallstone pancreatitis on clinical and PROs; the results of this trial will be used to inform patient care locally as well as to design future multicenter effectiveness and implementation trials. This trial will provide data regarding PROs including health-related quality of life that can be used in cost-utility and cost-effectiveness analyses. TRIAL REGISTRATION NUMBER: NCT02806297, ClinicalTrials.gov.