Laparoscopic Cholecystectomy in Idiopathic Pancreatitis

Idiopathic Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00784355
• Other study ID #: KUH5200616
• Status: Recruiting
• Phase: N/A
• Start date: January 2009
• Est. completion date: December 2018

Study information

• Verified date: August 2018
• Source: Kuopio University Hospital
• Contact: Hannu EK Paajanen, MD, PhD
• Phone: +358-44-3512220
• Email: hannu.paajanen[@]kuh.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• idiopathic pancreatitis

Exclusion Criteria:

• age < 18 years old

• patients' refusal

• high operative risks

• alcohol overuse

Related Conditions & MeSH terms

• Idiopathic Pancreatitis
• Pancreatitis

Intervention

Procedure:
• Laparoscopic cholecystectomy
Surgery

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Karne S, Gorelick FS. Etiopathogenesis of acute pancreatitis. Surg Clin North Am. 1999 Aug;79(4):699-710. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of acute pancreatitis		2 years
Secondary	etiology of acute pancreatitis in Finland in 2009-10		2 years