Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis
Condition: Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      There are controversies optimal timing for cholecystectomy in patients with mild biliary
      pancreatitis. The safety of cholecystectomy performed during an episode of pancreatitis has
      been questioned. The aim of the present randomized controlled trial is to compare the outcome
      in terms of recurrent pancreatitis and gallstone-related events between index
      cholecystectomy, performed during the first admission for acute pancreatitis, and scheduled
      cholecystectomy, performed 4-6 weeks after discharge.
    

Detailed description: 
      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.

      The IC and SC are protocolled to be performed within 24-48 hours from randomization, and
      after 6 weeks from discharge respectively. Daily blood samples, pain and well-being scores
      are obtained during index admission until discharge, at 1-month follow-up for SC group and at
      the scheduled cholecystectomy. Quality of life is assessed with SF-36 prior to randomization
      and 4 weeks after inclusion. Pain is measured with the McGill Pain Questionnaire before
      randomization and daily until discharge of two days after inclusion.

      Sample size estimation If IC reduces the risk of gallstone- or treatment-related adverse
      events from 40% to 10%, a total sample of 32 patients in each group is required in order to
      reach a chance of 80% of detecting a significant difference at the p<0.05 level. In order to
      compensate of drop-outs, a total sample of 70 is stipulated.
    

Intervention name(s): Index cholecystectomy; Scheduled cholecystectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Cholecystectomy performed within 48 hours after inclusion, before discharge after admission for acute biliary pancreatitis.; Cholecystectomy performed as a scheduled procedure 6 weeks after the first admission.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Biliary pancreatitis; Cholecystectomy