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

This study has been completed.

Sponsored by:	Erasme University Hospital
Information provided by:	Erasme University Hospital
ClinicalTrials.gov Identifier:	NCT00133835

Purpose

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	Intervention	Phase
Pancreatitis	Procedure: Extracorporeal shock wave lithotripsy Procedure: Endoscopic drainage of the main pancreatic duct	Phase I Phase II

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Comparison of ESWL Alone and ESWL Combined With Endoscopic Drainage of the Main Pancreatic Duct for Painful Chronic Pancreatitis

Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:

Relapse of pain at 2 years

Secondary Outcome Measures:

Diameter of the main pancreatic duct at 1 month
Complication rate at 1 month
Treatment-related costs of initial intervention and during follow-up

Estimated Enrollment:	50
Study Start Date:	March 1998
Estimated Study Completion Date:	July 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133835

Locations

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

Principal Investigator:	Jean-Marc Dumonceau	University Hospital of Geneva
Principal Investigator:	Jacques Devière	Erasme University Hospital
Principal Investigator:	Guido Costamagna	Catholic University of Roma

More Information

Study ID Numbers:	97.187
Study First Received:	August 22, 2005
Last Updated:	October 24, 2005
ClinicalTrials.gov Identifier:	NCT00133835
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment; Italy: Ministry of Health

Keywords provided by Erasme University Hospital:

Randomized controlled trial
Lithotripsy
Cholangiopancreatography, Endoscopic Retrograde
Abdominal pain

Study placed in the following topic categories:

Digestive System Diseases
Shock
Abdominal Pain
Pancreatic Diseases

Pain
Pancreatitis
Pancreatitis, Chronic

ClinicalTrials.gov processed this record on January 14, 2009