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

Société Française d'Endoscopie Digestive

Status and phase: Completed; Phase 3

Conditions: Large Common Bile Duct Stone; Choledocholithiasis

Treatments: Device: Large Balloon Dilatation of Oddi Sphincter; Procedure: ERCP; Procedure: Stone extraction; Procedure: Endoscopic Sphincterotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02592811

SocieteFranceED

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with CBD stones with a smaller diameter ≥ 13mm on cholangiogram

Exclusion criteria

• Active or history of acute pancreatitis
• Presence of intrahepatic stones
• History of Billroth II or roux-en-Y reconstruction
• Coagulation disorder (partial thromboplastin time > 42 seconds, prothrombin time (Quick value) < 50% and platelet count of <50 000/mm3)
• Current anticoagulation or clopidogrel treatment
• Pregnancy
• Inability to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

ESLBD

Active Comparator group

Description:

Endoscopic Sphincterotomy plus Large Balloon Dilatation +/- lithotripsy 1. ERCP with deep cancellation of BDS 2. Endoscopic large sphincterotomy 3. Large Balloon Dilatation of Oddi Sphincter: with the HERCULES, Cook 12, 15, 18 or 20 mm of diameter (adapted to stone diameter) 4. Stone extraction with dormia basket or extraction balloon 5. Mechanical Lithotripsy if needed

Treatment:

Procedure: Endoscopic Sphincterotomy

Procedure: ERCP

Procedure: Stone extraction

Device: Large Balloon Dilatation of Oddi Sphincter

CONV

Active Comparator group

Description:

Conventional treatment associating Endoscopic Sphincterotomy +/- Mechanical Lithotripsy (ES+/-LM) 1. ERCP with deep cancellation of BDS 2. Endoscopic large sphincterotomy 3. Stone extraction with dormia basket or extraction balloon 4. Mechanical Lithotripsy if needed

Treatment:

Procedure: Endoscopic Sphincterotomy

Procedure: ERCP

Procedure: Stone extraction