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Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis

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ClinicalTrials.gov Identifier: NCT02630433
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Gabriel Sandblom, Karolinska Institutet

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatitis Procedure: Index cholecystectomy Procedure: Scheduled cholecystectomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis
Study Start Date : August 2009
Actual Primary Completion Date : November 12, 2017
Actual Study Completion Date : November 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Index cholecystectomy
Cholecystectomy within 48 hours after inclusion.
Procedure: Index cholecystectomy
Cholecystectomy performed within 48 hours after inclusion, before discharge after admission for acute biliary pancreatitis.

Active Comparator: Scheduled cholecystectomy
Cholecystectomy 6 weeks after inclusion.
Procedure: Scheduled cholecystectomy
Cholecystectomy performed as a scheduled procedure 6 weeks after the first admission.




Primary Outcome Measures :
  1. Recurrent acute pancreatitis [ Time Frame: 6 weeks ]
    Relapse of acute pancreatitis in the scheduled cholecystectomy arm


Secondary Outcome Measures :
  1. Complications related to the cholecystectomy [ Time Frame: 30 days ]
    Complications according to the Clavien-Dindo classification

  2. Markers of inflammatory activity [ Time Frame: 3 days ]
    Inflammatory response measured with CRP and interleukins

  3. Health-related quality of life measured with SF-36 [ Time Frame: 6 weeks ]
    Health-related quality of life measured with SF-36 the day of inclusion and 6 weeks after inclusion

  4. Cost-effectiveness [ Time Frame: 6 weeks ]
    Costs from hospital stay, the surgical procedure and sick leave.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • S-Amylase >3 microkat/L
  • One or more gallstones with diameter < 2 cm
  • S-CRP < 150 mg/L the first 24 hours

Exclusion Criteria:

  • Multiple organ failure
  • Solitary gallstone with diameter >2 cm
  • Concurrent cholangitis
  • Hospital stay exceeding 72 hours before screening for inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630433


Locations
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Sweden
Karolinska University Hospital, Center for Digestive Diseases
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Gabriel Sandblom, Ass prof Karolinska Institutet, CLINTEC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gabriel Sandblom, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02630433     History of Changes
Other Study ID Numbers: Gallstenspancreatitistudien
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Gabriel Sandblom, Karolinska Institutet:
Biliary pancreatitis
Cholecystectomy
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases