Randomised Controlled Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis

Background:

There is still considerable debate regarding the optimal timing of cholecystectomy in mild biliary pancreatitis. It is widely accepted to wait until the patient's clinical condition allows performing cholecystectomy in severe biliary pancreatitis with systemic or local complications. On the other hand, the recommendations are not very clear when it comes to patients with mild biliary pancreatitis. The British Society of Gastroenterology and American Gastroenterological Association guidelines recommendation is to perform cholecystectomy within 2-to 4- week interval after the initial episode. However, the safety of cholecystectomy performed during an episode of pancreatitis is also controversial.

In a systematic review the overall readmission rate was 18% after index cholecystectomy, 8% for recurrent biliary pancreatitis, 3 % for acute cholecystitis and 7 % for biliary colic.

Methods The study is performed as a Randomised controlled trials with two parallel arms and a ratio of 1:1. Patients admitted with acute pancreatitis are checked for eligibility criteria for the study. Mild pancreatitis is defined as pancreatitis without local complications such as necrosis or organ failure. Patients who are eligible obtained oral and written information about the study and invited to be included. Patients who accept participation sign a consent form and are included. The included patients are randomized into index cholecystectomy (IC) or scheduled cholecystectomy (SC).

Randomization is done with a sealed envelope system. The allocation sequence is created by an online random generator. There is no blocking. After randomization, the patient as well as the responsible are immediately informed about the allocation.