Laparoscopic Cholecystectomy in Idiopathic Pancreatitis
Does Laparoscopic Cholecystectomy Prevent Recurrence in Idiopathic Pancreatitis? A Prospective Multicentre Randomized Study
1 other identifier
interventional
200
1 country
1
Brief Summary
The causes of acute pancreatitis in Finland are alcohol overuse (60%), cholecystolithiasis (20%) and idiopathic (i.e. etiology unknown)(20%). Acute pancreatitis may recur in over half of cases and may be fatal in severe cases in 30%. Majority of idiopathic pancreatitis are caused by microlithiasis in gall bladder. The purpose of this randomized study is to prevent recurrence of idiopathic pancreatitis by performing laparoscopic cholecystectomy compared to non-operative group in 2 years follow-up of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 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
First Submitted
Initial submission to the registry
October 31, 2008
CompletedFirst Posted
Study publicly available on registry
November 3, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 14, 2018
August 1, 2018
9.9 years
October 31, 2008
August 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recurrence of acute pancreatitis
2 years
Secondary Outcomes (1)
etiology of acute pancreatitis in Finland in 2009-10
2 years
Study Arms (2)
1:Laparoscopic cholecystectomy
EXPERIMENTALSurgery
2:controls
NO INTERVENTIONnon-surgical control group
Interventions
Surgery
Eligibility Criteria
You may qualify if:
- idiopathic pancreatitis
You may not qualify if:
- age \< 18 years old
- patients' refusal
- high operative risks
- alcohol overuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kuopio University Hospital
Kuopio, 70211, Finland
Related Publications (2)
Karne S, Gorelick FS. Etiopathogenesis of acute pancreatitis. Surg Clin North Am. 1999 Aug;79(4):699-710. doi: 10.1016/s0039-6109(05)70036-0.
PMID: 10470320BACKGROUNDRaty S, Pulkkinen J, Nordback I, Sand J, Victorzon M, Gronroos J, Helminen H, Kuusanmaki P, Nordstrom P, Paajanen H. Can Laparoscopic Cholecystectomy Prevent Recurrent Idiopathic Acute Pancreatitis?: A Prospective Randomized Multicenter Trial. Ann Surg. 2015 Nov;262(5):736-41. doi: 10.1097/SLA.0000000000001469.
PMID: 26583660DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
- MD, PhD
Study Record Dates
First Submitted
October 31, 2008
First Posted
November 3, 2008
Study Start
January 1, 2009
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
August 14, 2018
Record last verified: 2018-08