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Comparison of Extracorporeal Shock Wave Lithotripsy (ESWL) Alone and ESWL Plus Endoscopy for Painful Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT00133835
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : October 25, 2005
Sponsor:
Information provided by:
Erasme University Hospital

Brief Summary:
Endoscopy is an established method of treatment for painful obstructive calcified pancreatitis. It involves the disintegration of calcifications using extracorporeal shock wave lithotripsy (ESWL) followed by endoscopic removal of stone fragments possibly associated with stent insertion. A pilot study suggests that ESWL alone relieves pain in calcified chronic pancreatitis (CP). The aim of this study is to compare both techniques in a randomized controlled trial.

Condition or disease Intervention/treatment Phase
Pancreatitis Procedure: Extracorporeal shock wave lithotripsy Procedure: Endoscopic drainage of the main pancreatic duct Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of ESWL Alone and ESWL Combined With Endoscopic Drainage of the Main Pancreatic Duct for Painful Chronic Pancreatitis
Study Start Date : March 1998
Study Completion Date : July 2005

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Primary Outcome Measures :
  1. Relapse of pain at 2 years

Secondary Outcome Measures :
  1. Diameter of the main pancreatic duct at 1 month
  2. Complication rate at 1 month
  3. Treatment-related costs of initial intervention and during follow-up


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

Inclusion Criteria:

  • Painful chronic pancreatitis (>1 abdominal pain attack during the preceding 12 months)
  • At least 1 calcified stone greater than 4 mm in one of its axes in the cephalic or corporeal portion of the main pancreatic duct (MPD) with upstream duct dilation
  • Written informed consent obtained from the patient

Exclusion Criteria:

  • History of treatment of the pancreas using ESWL, endoscopy, or surgery
  • Pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT scan
  • Alkaline phosphatase levels greater than twice the upper limit of normal values or signs of cholangitis
  • Age below 18 years
  • Pregnancy or lactation

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): NCT00133835


Locations
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Belgium
Department of Gastroenterology and Hepatopancretology; Erasme University Hospital
Brussels, Belgium, 1070
Italy
Digestive Endoscopy Unit, Department of Surgery, Catholic University
Rome, Italy, 00168
Sponsors and Collaborators
Erasme University Hospital
Investigators
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Principal Investigator: Jean-Marc Dumonceau University Hospital, Geneva
Principal Investigator: Jacques Devière Erasme University Hospital
Principal Investigator: Guido Costamagna Catholic University of Roma

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ClinicalTrials.gov Identifier: NCT00133835     History of Changes
Other Study ID Numbers: 97.187
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: October 25, 2005
Last Verified: July 2005
Keywords provided by Erasme University Hospital:
Randomized controlled trial
Lithotripsy
Cholangiopancreatography, Endoscopic Retrograde
Abdominal pain
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases