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Laparoscopic Cholecystectomy in Idiopathic Pancreatitis

This study is currently recruiting participants.
Verified March 2016 by Hannu Paajanen, Kuopio University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00784355
First Posted: November 3, 2008
Last Update Posted: March 9, 2017
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.
Information provided by (Responsible Party):
Hannu Paajanen, Kuopio University Hospital
  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
Idiopathic Pancreatitis Procedure: Laparoscopic cholecystectomy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hannu Paajanen, Kuopio University Hospital:

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

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

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hannu Paajanen, MD, PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00784355     History of Changes
Other Study ID Numbers: KUH5200616
First Submitted: October 31, 2008
First Posted: November 3, 2008
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:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases


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