Laparoscopic Cholecystectomy in Idiopathic Pancreatitis
- Conditions
- Idiopathic Pancreatitis
- Interventions
- Procedure: Laparoscopic cholecystectomy
- Registration Number
- NCT00784355
- Lead Sponsor
- Kuopio University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- idiopathic pancreatitis
- age < 18 years old
- patients' refusal
- high operative risks
- alcohol overuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1:Laparoscopic cholecystectomy Laparoscopic cholecystectomy Surgery
- Primary Outcome Measures
Name Time Method recurrence of acute pancreatitis 2 years
- Secondary Outcome Measures
Name Time Method etiology of acute pancreatitis in Finland in 2009-10 2 years
Trial Locations
- Locations (1)
Kuopio University Hospital
🇫🇮Kuopio, Finland