Laparoscopic Cholecystectomy in Idiopathic Pancreatitis

Kuopio University Hospital

Status: Unknown

Conditions: Idiopathic Pancreatitis

Treatments: Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00784355

KUH5200616

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• idiopathic pancreatitis

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

1:Laparoscopic cholecystectomy

Experimental group

Description:

Surgery

Treatment:

Procedure: Laparoscopic cholecystectomy

2:controls

No Intervention group

Description:

non-surgical control group