Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis
Randomised Controlled Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis
1 other identifier
interventional
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 6, 2015
CompletedFirst Posted
Study publicly available on registry
December 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2017
CompletedNovember 14, 2017
November 1, 2017
8.3 years
December 6, 2015
November 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrent acute pancreatitis
Relapse of acute pancreatitis in the scheduled cholecystectomy arm
6 weeks
Secondary Outcomes (4)
Complications related to the cholecystectomy
30 days
Markers of inflammatory activity
3 days
Health-related quality of life measured with SF-36
6 weeks
Cost-effectiveness
6 weeks
Study Arms (2)
Index cholecystectomy
EXPERIMENTALCholecystectomy within 48 hours after inclusion.
Scheduled cholecystectomy
ACTIVE COMPARATORCholecystectomy 6 weeks after inclusion.
Interventions
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.
Eligibility Criteria
You may qualify if:
- S-Amylase \>3 microkat/L
- One or more gallstones with diameter \< 2 cm
- S-CRP \< 150 mg/L the first 24 hours
You may not qualify if:
- Multiple organ failure
- Solitary gallstone with diameter \>2 cm
- Concurrent cholangitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska University Hospital, Center for Digestive Diseases
Stockholm, 14186, Sweden
Related Publications (1)
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.
PMID: 29703649DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel Sandblom, Ass prof
Karolinska Institutet, CLINTEC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 6, 2015
First Posted
December 15, 2015
Study Start
August 1, 2009
Primary Completion
November 12, 2017
Study Completion
November 12, 2017
Last Updated
November 14, 2017
Record last verified: 2017-11