- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02630433
Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis
Randomised Controlled Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Stockholm, Sweden, 14186
- Karolinska University Hospital, Center for Digestive Diseases
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Index cholecystectomy
Cholecystectomy within 48 hours after inclusion.
|
Cholecystectomy performed within 48 hours after inclusion, before discharge after admission for acute biliary pancreatitis.
|
Active Comparator: Scheduled cholecystectomy
Cholecystectomy 6 weeks after inclusion.
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Cholecystectomy performed as a scheduled procedure 6 weeks after the first admission.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrent acute pancreatitis
Time Frame: 6 weeks
|
Relapse of acute pancreatitis in the scheduled cholecystectomy arm
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications related to the cholecystectomy
Time Frame: 30 days
|
Complications according to the Clavien-Dindo classification
|
30 days
|
Markers of inflammatory activity
Time Frame: 3 days
|
Inflammatory response measured with CRP and interleukins
|
3 days
|
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
|
6 weeks
|
Cost-effectiveness
Time Frame: 6 weeks
|
Costs from hospital stay, the surgical procedure and sick leave.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gabriel Sandblom, Ass prof, Karolinska Institutet, CLINTEC
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gallstenspancreatitistudien
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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