Laparoscopic Cholecystectomy in Idiopathic Pancreatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Kuopio University Hospital
Sponsor:
Information provided by (Responsible Party):
Hannu Paajanen, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00784355
First received: October 31, 2008
Last updated: September 10, 2014
Last verified: September 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Laparoscopic Cholecystectomy Prevent Recurrence in Idiopathic Pancreatitis? A Prospective Multicentre Randomized Study

Resource links provided by NLM:


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 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1:Laparoscopic cholecystectomy
Surgery
Procedure: Laparoscopic cholecystectomy
Surgery
Other Names:
  • idiopathic pancreatitis
  • cholecystectomy
No Intervention: 2:controls
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
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, see Learn About Clinical Studies.

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

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

Locations
Finland
Kuopio University Hospital Recruiting
Kuopio, Finland, 70211
Contact: Hannu Paajanen, MD, PhD       hannu.paajanen@esshp.fi   
Contact: Sari Gronlund, MD, PhD       sari.gronlund@kuh.fi   
Sub-Investigator: Sari Gronlund, MD, PhD         
Principal Investigator: Hannu EK Paajanen, MD, PhD         
Sponsors and Collaborators
Kuopio University Hospital
  More Information

Publications:
Responsible Party: Hannu Paajanen, MD, PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00784355     History of Changes
Other Study ID Numbers: KUH5200616
Study First Received: October 31, 2008
Last Updated: September 10, 2014
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

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 14, 2014