Laparoscopic Cholecystectomy in Idiopathic Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00784355
Recruitment Status : Recruiting
First Posted : November 3, 2008
Last Update Posted : March 9, 2017
Information provided by (Responsible Party):
Hannu Paajanen, 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.

Condition or disease Intervention/treatment Phase
Idiopathic Pancreatitis Procedure: Laparoscopic cholecystectomy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Laparoscopic Cholecystectomy Prevent Recurrence in Idiopathic Pancreatitis? A Prospective Multicentre Randomized Study
Study Start Date : January 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: 1:Laparoscopic cholecystectomy
Procedure: Laparoscopic cholecystectomy
Other Names:
  • idiopathic pancreatitis
  • cholecystectomy

No Intervention: 2:controls
non-surgical control group

Primary Outcome Measures :
  1. recurrence of acute pancreatitis [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. etiology of acute pancreatitis in Finland in 2009-10 [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • idiopathic pancreatitis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00784355

Contact: Hannu EK Paajanen, MD, PhD +358-44-3512220
Contact: Sari Paajanen, MD, PhD

Kuopio University Hospital Recruiting
Kuopio, Finland, 70211
Contact: Hannu Paajanen, MD, PhD   
Contact: Sari Gronlund, MD, PhD   
Sub-Investigator: Sari Gronlund, MD, PhD         
Principal Investigator: Hannu EK Paajanen, MD, PhD         
Sponsors and Collaborators
Kuopio University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hannu Paajanen, MD, PhD, Kuopio University Hospital Identifier: NCT00784355     History of Changes
Other Study ID Numbers: KUH5200616
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hannu Paajanen, Kuopio University Hospital:
recurrence of idiopathic pancreatitis
laparoscopic cholecystectomy
etiology of pancreatitis

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases