Comparison of Two Management Strategies, "Endoscopy First" and "Laparoscopic Cholecystectomy First", for Patients With Gallbladder Stones and Intermediate Risk for Choledocholithiasis
试验速览
- 阶段
- 不适用
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Duration of treatment
研究概览
简要总结
The study compares two different methods to evaluate extrahepatic bile ducts for possible stones for patients with cholecystolithiasis and intermediate risk for choledocholithiasis when laparoscopic cholecystectomy is indicated.
Endosonoscopic evaluation of bile ducts and endoscopic retrograde cholangiography (ERCP) on demand are performed before laparoscopic cholecystectomy for one arm. Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative ERCP on demand are administered in another arm.
详细描述
Use of ERCP as a diagnostic tool should be minimized as it carries considerable risk (5 to 10%) of post-procedural complications. It is noticed that adverse events occur more often to patients with low risk of choledocholithiasis. Therefore the best possible patient selection for ERCP procedure is needed.
At the Centre of Abdominal Surgery of Vilnius University Hospital Santaros klinikos an original prognostic index (Vilnius University Hospital index (VUHI)) is used for evaluation of risk of choledocholithiasis. It is calculated by formula VUHI = A/30 + 0.4×B, where A - total bilirubin concentration (µmol/l), B - common bile duct (CBD) diameter measured by ultrasound exam. A retrospective study evaluated its accuracy and determined threshold values for low, intermediate and high risk groups. The intermediate risk group (risk for choledocholithiasis 25-75%) would benefit from additional examination before ERCP. Endoscopic ultrasound (EUS) and intraoperative cholangiography are less invasive procedures with high accuracy identifying common bile duct stones. Main hypothesis of the trial is that intraoperative cholangiography with ERCP on demand can shorten the duration and costs of treatment and avoid diagnostic ERCPs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with cholecystolithiasis when laparoscopic cholecystectomy is indicated
- •intermediate risk for choledocholithiasis (VUHI 2,6 - 6,9 and one of the predictors: dilated common bile duct, elevated total bilirubin or suspected stone in CBD on ultrasound)
排除标准
- •pregnancy;
- •acute cholangitis;
- •biliary pancreatitis;
- •acute cholecystitis, degree II-III by Tokyo guidelines 2013;
- •anastomosis in upper gastrointestinal tract;
- •other known cholestatic hepatopancreatobiliary disease;
- •known or suspected hepatitis of another origin (viral, toxic, etc.);
- •contraindications for general anaesthesia or surgery;
- •IV-VI class of American Society of Anesthesiologists physical status classification;
- •morbid obesity (body mass index > 40);
- •patient's refusal to participate in the study.
结局指标
主要结局
Duration of treatment
时间窗: up to one month
duration from admission to hospital or decision to perform laparoscopic cholecystectomy to discharge in days
次要结局
- Accuracy of different management strategies(6 to 7 months)
- Costs of treatment(up to one month)
- Technical success of interventions (IOC, EUS, ERCP)(up to one month)
- Adverse events of interventions(up to one month)
研究者
Ausra Aleknaite
Investigator
Vilnius University