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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- Success of common bile duct clearance in one session of ERCP (endoscopic retrograde cholangiopancreatography)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with CBD stones with a smaller diameter ≥ 13mm on cholangiogram
排除标准
- •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
结局指标
主要结局
Success of common bile duct clearance in one session of ERCP (endoscopic retrograde cholangiopancreatography)
时间窗: 1 month
次要结局
- 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)
研究者
KARSENTI
MD
Société Française d'Endoscopie Digestive