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Laparoscopic Cholecystectomy in Idiopathic Pancreatitis

Primary Purpose

Idiopathic Pancreatitis

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pancreatitis focused on measuring recurrence of idiopathic pancreatitis, laparoscopic cholecystectomy, etiology of pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • idiopathic pancreatitis

Exclusion Criteria:

  • age < 18 years old
  • patients' refusal
  • high operative risks
  • alcohol overuse

Sites / Locations

  • Kuopio University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1:Laparoscopic cholecystectomy

2:controls

Arm Description

Surgery

non-surgical control group

Outcomes

Primary Outcome Measures

recurrence of acute pancreatitis

Secondary Outcome Measures

etiology of acute pancreatitis in Finland in 2009-10

Full Information

First Posted
October 31, 2008
Last Updated
August 11, 2018
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00784355
Brief Title
Laparoscopic Cholecystectomy in Idiopathic Pancreatitis
Official Title
Does Laparoscopic Cholecystectomy Prevent Recurrence in Idiopathic Pancreatitis? A Prospective Multicentre Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Etiologic investigations include serum amylase, lipase, triglyceride and calcium determination, as well as abdominal ultrasound scanning. Alcohol consumption is asked by using WHO audit test. After etiology of acute pancreatitis has been confirmed as idiopathic, 100 patients are randomized to laparoscopic cholecystectomy and 100 patients to follow-up of 2 years. Five to seven Finnish university and main central hospitals are participating the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pancreatitis
Keywords
recurrence of idiopathic pancreatitis, laparoscopic cholecystectomy, etiology of pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1:Laparoscopic cholecystectomy
Arm Type
Experimental
Arm Description
Surgery
Arm Title
2:controls
Arm Type
No Intervention
Arm Description
non-surgical control group
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Other Intervention Name(s)
idiopathic pancreatitis, cholecystectomy
Intervention Description
Surgery
Primary Outcome Measure Information:
Title
recurrence of acute pancreatitis
Time Frame
2 years
Secondary Outcome Measure Information:
Title
etiology of acute pancreatitis in Finland in 2009-10
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: idiopathic pancreatitis Exclusion Criteria: age < 18 years old patients' refusal high operative risks alcohol overuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannu EK Paajanen, MD, PhD
Phone
+358-44-3512220
Email
hannu.paajanen@kuh.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Sari Paajanen, MD, PhD
Email
hannu.paajanen@kuh.fi
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannu Paajanen, MD, PhD
Email
hannu.paajanen@esshp.fi
First Name & Middle Initial & Last Name & Degree
Sari Gronlund, MD, PhD
Email
sari.gronlund@kuh.fi
First Name & Middle Initial & Last Name & Degree
Sari Gronlund, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hannu EK Paajanen, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
10470320
Citation
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.
Results Reference
background
PubMed Identifier
26583660
Citation
Raty 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.
Results Reference
derived

Learn more about this trial

Laparoscopic Cholecystectomy in Idiopathic Pancreatitis

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