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Laparoscopic Cholecystectomy in Idiopathic Pancreatitis

Does Laparoscopic Cholecystectomy Prevent Recurrence in Idiopathic Pancreatitis? A Prospective Multicentre Randomized Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00784355
Enrollment
200
Registered
2008-11-03
Start date
2009-01-31
Completion date
2018-12-31
Last updated
2018-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pancreatitis

Keywords

recurrence of idiopathic pancreatitis, laparoscopic cholecystectomy, etiology of pancreatitis

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.

Interventions

PROCEDURELaparoscopic cholecystectomy

Surgery

Sponsors

Kuopio University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* idiopathic pancreatitis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
recurrence of acute pancreatitis2 years

Secondary

MeasureTime frame
etiology of acute pancreatitis in Finland in 2009-102 years

Countries

Finland

Contacts

Primary ContactHannu EK Paajanen, MD, PhD
hannu.paajanen@kuh.fi+358-44-3512220
Backup ContactSari Paajanen, MD, PhD
hannu.paajanen@kuh.fi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026