Endoscopic Sphincterotomy Plus Large-Balloon Dilatation (ESLBD) Versus Conventional Endoscopic Treatment for Removal of Large Common Bile Duct Stones : A Prospective Comparative Multi Center Randomized Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Primary Endpoint
- Success of common bile duct clearance in one session of ERCP (endoscopic retrograde cholangiopancreatography)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Success of common bile duct clearance in one session of ERCP (endoscopic retrograde cholangiopancreatography)
Time Frame: 1 month
Secondary Outcomes
- Number of patients with mild or severe BLEEDING (Morbidity) after ERCP(1 month)
- Number of patients with mild or severe ACUTE PANCREATITIS (Morbidity) after ERCP(1 month)
- Number of patients with PERFORATION (Morbidity of ERCP)(1 day)
- Number of patients with post ERCP INFECTION as angiocholitis, cholecystitis or urine infection, septicemia (Morbidity of ERCP)(1 month)
- Cost of procedure(Day one)
- GLOBAL MORBIDITY of ERCP (number of patients with bleeding and/or acute pancreatistis and/or perforation and/or infection)(1 month)
- MORTALITY of ERCP(1 month)
- Number of patients with recurrence of BDS(1 month)
- Length of procedure(Day one)
- comparison of the frequency of mechanical lithotripsy of both groups(Day one)
Investigators
KARSENTI
MD
Société Française d'Endoscopie Digestive