MedTrace Logo

Comparison of Endoscopic Sphincterotomy Plus Large-balloon Dilatation and Conventional Treatment for Large CBD Stones

NCT02592811 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-10-30

No results posted yet for this study

Summary

Bile duct stone extraction is impossible after endoscopic sphincterotomy (ES) alone in approximatively 10% of cases (mostly because of stones' size). Adjunction of a mechanical lithotripsy (ML) is well established to improve clearance of common bile duct (CBD) stones. Because of inconstant success, high cost, and length of procedure, an alternative method was proposed in 2003: endoscopic sphincterotomy plus large balloon dilatation (ESLBD). If the safety of ESLBD is accepted in all recent published studies, it remains controversial wether ESLBD is superior to conventional endoscopic treatment associating ES± ML for CBD stones. Procedure treatment and place of ESLBD in CBD stones therapeutic strategy is unclear.

The purpose of this prospective comparative multi center randomized study is to evaluate the superiority or not of ESLBD on conventional treatment (ES±ML) for the treatment of large bile duct stone (≥13mm) after standard ES, and to propose a new CBD stones therapeutic strategy.

Conditions

  • Choledocholithiasis
  • Large Common Bile Duct Stone

Interventions

PROCEDURE

ERCP

Common bile duct cannulation with a cannulation catheter

PROCEDURE

Endoscopic Sphincterotomy

Endoscopic large sphincterotomy

DEVICE

Large Balloon Dilatation of Oddi Sphincter

Large Balloon Dilatation : with the HERCULES, Cook 12, 15, 18 or 20 mm of diameter (adapted to stone diameter)

PROCEDURE

Stone extraction

After dilatation, extraction of stones is done with dormia basket or extraction balloon and if not possible a mechanical lithotripsy is performed

Sponsors & Collaborators

  • Société Française d'Endoscopie Digestive

    lead OTHER

Principal Investigators

  • David KARSENTI, MD · Société Française d'Endoscopie Digestive

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2015-03-31
Completion
2015-03-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02592811 on ClinicalTrials.gov