Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis
Primary Purpose
Pancreatitis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Index cholecystectomy
Scheduled cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatitis focused on measuring Biliary pancreatitis, Cholecystectomy
Eligibility 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
Sites / Locations
- Karolinska University Hospital, Center for Digestive Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Index cholecystectomy
Scheduled cholecystectomy
Arm Description
Cholecystectomy within 48 hours after inclusion.
Cholecystectomy 6 weeks after inclusion.
Outcomes
Primary Outcome Measures
Recurrent acute pancreatitis
Relapse of acute pancreatitis in the scheduled cholecystectomy arm
Secondary Outcome Measures
Complications related to the cholecystectomy
Complications according to the Clavien-Dindo classification
Markers of inflammatory activity
Inflammatory response measured with CRP and interleukins
Health-related quality of life measured with SF-36
Health-related quality of life measured with SF-36 the day of inclusion and 6 weeks after inclusion
Cost-effectiveness
Costs from hospital stay, the surgical procedure and sick leave.
Full Information
NCT ID
NCT02630433
First Posted
December 6, 2015
Last Updated
November 12, 2017
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02630433
Brief Title
Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis
Official Title
Randomised Controlled Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 12, 2017 (Actual)
Study Completion Date
November 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
Biliary pancreatitis, Cholecystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Index cholecystectomy
Arm Type
Experimental
Arm Description
Cholecystectomy within 48 hours after inclusion.
Arm Title
Scheduled cholecystectomy
Arm Type
Active Comparator
Arm Description
Cholecystectomy 6 weeks after inclusion.
Intervention Type
Procedure
Intervention Name(s)
Index cholecystectomy
Intervention Description
Cholecystectomy performed within 48 hours after inclusion, before discharge after admission for acute biliary pancreatitis.
Intervention Type
Procedure
Intervention Name(s)
Scheduled cholecystectomy
Intervention Description
Cholecystectomy performed as a scheduled procedure 6 weeks after the first admission.
Primary Outcome Measure Information:
Title
Recurrent acute pancreatitis
Description
Relapse of acute pancreatitis in the scheduled cholecystectomy arm
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Complications related to the cholecystectomy
Description
Complications according to the Clavien-Dindo classification
Time Frame
30 days
Title
Markers of inflammatory activity
Description
Inflammatory response measured with CRP and interleukins
Time Frame
3 days
Title
Health-related quality of life measured with SF-36
Description
Health-related quality of life measured with SF-36 the day of inclusion and 6 weeks after inclusion
Time Frame
6 weeks
Title
Cost-effectiveness
Description
Costs from hospital stay, the surgical procedure and sick leave.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Sandblom, Ass prof
Organizational Affiliation
Karolinska Institutet, CLINTEC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital, Center for Digestive Diseases
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29703649
Citation
Noel R, Arnelo U, Lundell L, Hammarqvist F, Jumaa H, Enochsson L, Sandblom G. Index versus delayed cholecystectomy in mild gallstone pancreatitis: results of a randomized controlled trial. HPB (Oxford). 2018 Oct;20(10):932-938. doi: 10.1016/j.hpb.2018.03.016. Epub 2018 Apr 25.
Results Reference
derived
Learn more about this trial
Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis
We'll reach out to this number within 24 hrs