NCT00133835

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 1998

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
16.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2022

Completed
Last Updated

March 9, 2022

Status Verified

July 1, 2005

Enrollment Period

24 years

First QC Date

August 22, 2005

Last Update Submit

February 21, 2022

Conditions

Pancreatitis

Keywords

Randomized controlled trialLithotripsyCholangiopancreatography, Endoscopic RetrogradeAbdominal pain

Outcome Measures

Primary Outcomes (1)

  • Relapse of pain at 2 years

Secondary Outcomes (3)

  • Diameter of the main pancreatic duct at 1 month

  • Complication rate at 1 month

  • Treatment-related costs of initial intervention and during follow-up

Interventions

Extracorporeal shock wave lithotripsyPROCEDURE
Endoscopic drainage of the main pancreatic ductPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Gastroenterology and Hepatopancretology; Erasme University Hospital

Brussels, 1070, Belgium

Location

Digestive Endoscopy Unit, Department of Surgery, Catholic University

Rome, 00168, Italy

Location

MeSH Terms

Conditions

PancreatitisAbdominal Pain

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

TherapeuticsUltrasonic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jean-Marc Dumonceau

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

  • Jacques Devière

    Erasme University Hospital

    PRINCIPAL INVESTIGATOR

  • Guido Costamagna

    Catholic University of Roma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

March 1, 1998

Primary Completion

February 21, 2022

Study Completion

February 21, 2022

Last Updated

March 9, 2022

Record last verified: 2005-07

Locations

IT(1)BE(1)