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Comparison of ESWL Alone and ESWL + Endoscopy for Painful Chronic Pancreatitis

Primary Purpose

Pancreatitis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Extracorporeal shock wave lithotripsy
Endoscopic drainage of the main pancreatic duct
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring Randomized controlled trial, Lithotripsy, Cholangiopancreatography, Endoscopic Retrograde, Abdominal pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gastroenterology and Hepatopancretology; Erasme University Hospital
  • Digestive Endoscopy Unit, Department of Surgery, Catholic University

Outcomes

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

Full Information

First Posted
August 22, 2005
Last Updated
February 21, 2022
Sponsor
Erasme University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00133835
Brief Title
Comparison of ESWL Alone and ESWL + Endoscopy for Painful Chronic Pancreatitis
Official Title
Comparison of ESWL Alone and ESWL Combined With Endoscopic Drainage of the Main Pancreatic Duct for Painful Chronic Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
February 21, 2022 (Actual)
Study Completion Date
February 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erasme University Hospital

4. Oversight

5. Study Description

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.
Detailed Description
Endoscopic drainage of the main pancreatic duct is an established method of treatment of painful obstructive calcified chronic pancreatitis (CP). It involves 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 in calcified CP is followed by spontaneous elimination of stone fragments and pain relief, without sphincterotomy. After ESWL alone, the exocrine function was found to return to normal values in some cases. Potential benefits include lower costs and morbidity as well as wider availability compared to endoscopic techniques. The primary outcome of this randomized controlled trial is to compare the relapse of pain at 2 years after treatment with ESWL alone or endoscopic treatment, consisting of ESWL followed by endoscopic stone extraction. Secondary outcomes include a comparison of technical results (as assessed by abdominal CT Scan 1 week after the last intervention and secretin-enhanced magnetic resonance at 1 month), complication rates, and treatment-related costs in both groups. Patients are eligible to participate in the study according to the following criteria: Inclusion criteria : painful chronic pancreatitis (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 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. Pretherapeutic work-up will include detailed medical history (including date of the first episode of typical abdominal pain, date of diagnosis of CP, number of episodes of pain during the last year, alcohol intake, pain continuous or intermittent during the last episode, medication, intensity of the last episode of pain on a 10-point scale as previously described), blood chemistry, stool sampling (for elastase measurement), triolein breath test, plain abdominal film taken in four classical positions (left anterior oblique, right anterior oblique, lateral, and supine), CT Scan without contrast medium injection, and secretin-enhanced magnetic resonance cholangiopancreatography (S-MRCP). After informed consent of the referring physician has been obtained, patients will be asked to participate in the study. If the patient accepts, after oral and written consent, he (or she) will be randomized to the ESWL or endoscopy group by opening an opaque sealed envelope numbered according to a table of random numbers. ESWL will be performed in all patients using a electromagnetic lithotriptor as previously described. Shock-waves will be focused on the obstructing stones (if multiple stones are present, those responsible for MPD obstruction will be identified by comparing plain abdominal film, CT Scan and S-MRCP). ESWL sessions will be repeated if necessary, until stone fragmentation is obtained, as confirmed by abdominal plain film centered on the targeted area of the pancreas. At this time, treatment will be considered terminated in the ESWL group, patients in the endoscopy group will undergo endoscopy immediately, for endoscopic extraction of stone fragments possibly associated to stent insertion according to previously published criteria and techniques. Cross-over: in the ESWL group, if no elimination of the fragments is observed one week after the last ESWL, endoscopic drainage of the main pancreatic duct will be carried out at this time in case of continuous pain. For patients without continuous pain, delayed spontaneous elimination of the fragments will be sought by CT Scan and S-MRCP 2 months after the last ESWL. Endoscopic drainage of the main pancreatic duct will be proposed during follow-up only to the patients presenting a painful attack of CP. Follow-up will consist of clinical examination 1 month after treatment and every 6 months thereafter. Data collected will include pain relapses, ESWL, endoscopic and surgical procedures, weight change, plus any other seemingly unrelated medical treatments. In addition to this, a S-MRCP will be performed 1 month after treatment. Triolein breath test will be performed at 1 month and 1 year. Sampling of stools (for elastase measurement) will be obtained every year. Costs will be calculated starting on the day of first treatment as previously described. Costs not directly related to the treatment of pain or of procedure-related complications (e.g., diabetes) will be disregarded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
Randomized controlled trial, Lithotripsy, Cholangiopancreatography, Endoscopic Retrograde, Abdominal pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Extracorporeal shock wave lithotripsy
Intervention Type
Procedure
Intervention Name(s)
Endoscopic drainage of the main pancreatic duct
Primary Outcome Measure Information:
Title
Relapse of pain at 2 years
Secondary Outcome Measure Information:
Title
Diameter of the main pancreatic duct at 1 month
Title
Complication rate at 1 month
Title
Treatment-related costs of initial intervention and during follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc Dumonceau
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacques Devière
Organizational Affiliation
Erasme University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guido Costamagna
Organizational Affiliation
Catholic University of Roma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology and Hepatopancretology; Erasme University Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Digestive Endoscopy Unit, Department of Surgery, Catholic University
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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Comparison of ESWL Alone and ESWL + Endoscopy for Painful Chronic Pancreatitis

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