Laparoscopic Cholecystectomy in Idiopathic Pancreatitis - Full Text View

Sponsored by:	Kuopio University Hospital
Information provided by:	Kuopio University Hospital
ClinicalTrials.gov Identifier:	NCT00784355

Purpose

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.

Condition	Intervention	Phase
Idiopathic Pancreatitis	Procedure: Laparoscopic cholecystectomy	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Does Laparoscopic Cholecystectomy Prevent Recurrence in Idiopathic Pancreatitis? A Prospective Multicentre Randomized Study

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:

recurrence of acute pancreatitis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

etiology of acute pancreatitis in Finland in 2009-10 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1:Laparoscopic cholecystectomy: Experimental Surgery	Procedure: Laparoscopic cholecystectomy Surgery
2:controls: No Intervention non-surgical control group

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

idiopathic pancreatitis

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784355

Contacts

Contact: Hannu EK Paajanen, MD, PhD	+358-44-3512220	hannu.paajanen@esshp.fi
Contact: Sari Gronlund, MD, PhD		sari.gronlund@kuh.fi

Locations

Finland
Kuopio University Hospital
Kuopio, Finland, 70211

Sponsors and Collaborators

Kuopio University Hospital

More Information

Publications:

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

Responsible Party:	Department of Surgery, Mikkeli Central Hospital, Finland ( Hannu Paajanen MD )
Study ID Numbers:	KUH5200616
Study First Received:	October 31, 2008
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00784355
Health Authority:	Finland: Ethical Comittee of Southern Savo Hospital District

Keywords provided by Kuopio University Hospital:

recurrence of idiopathic pancreatitis
laparoscopic cholecystectomy
etiology of pancreatitis

Study placed in the following topic categories:

Digestive System Diseases
Pancreatic Diseases
Recurrence
Pancreatitis

ClinicalTrials.gov processed this record on January 16, 2009