Laparoscopic Cholecystectomy in Idiopathic Pancreatitis

NCT ID: NCT00784355

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Idiopathic Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1:Laparoscopic cholecystectomy

Surgery

Group Type EXPERIMENTAL

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Surgery

2:controls

non-surgical control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Laparoscopic cholecystectomy

Surgery

Intervention Type PROCEDURE

Other Intervention Names

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idiopathic pancreatitis cholecystectomy

Eligibility Criteria

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Inclusion Criteria

* idiopathic pancreatitis

Exclusion Criteria

* age \< 18 years old
* patients' refusal
* high operative risks
* alcohol overuse
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hannu Paajanen

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kuopio University Hospital

Kuopio, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Hannu EK Paajanen, MD, PhD

Role: CONTACT

+358-44-3512220

Sari Paajanen, MD, PhD

Role: CONTACT

Facility Contacts

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Hannu Paajanen, MD, PhD

Role: primary

Sari Gronlund, MD, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 10470320 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26583660 (View on PubMed)

Other Identifiers

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KUH5200616

Identifier Type: -

Identifier Source: org_study_id

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