Comparative Study of ERCP, ERCP Plus Laparoscopic Cholecystectomy, and Conservative Management in Patients With Concomitant Choledocholithiasis and Cholecystolithiasis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Assess the clinical safety of ERCP-GPC ,LC and conservative treatments by evaluating the incidence of intraoperative,short-term and long-term postoperative complications.
研究概览
简要总结
Recruit patients with cholelithiasis with concomitant choledocholithiasis into the cohort, and assign them to undergo endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment based on patient preference. Collect clinical data and patient-reported outcomes regularly at baseline and during follow-up in the cohort. Assess the clinical safety of ERCP-GPC and LC by evaluating the clinical success rate of treatment as well as the incidence of short-term and long-term postoperative complications; investigate the efficacy differences among endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment in managing cholelithiasis with concomitant choledocholithiasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients over the age of 18 years;
- •Ultrasound, MRCP, or other imaging examination findings (CT/MRI) clearly indicate a diagnosis of cholelithiasis with concomitant choledocholithiasis;
- •Patients with no history of gastrointestinal reconstruction surgery or cholecystectomy or previous biliary tract surgery (include history of ERCP);
- •Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;
- •The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm;
- •Voluntary provision of signed informed consent.
排除标准
- •Atrophic cholecystitis; porcelain gallbladder; suspect malignant tumor of the gallbladder; stenosis of the lower segment of the common bile duct; Mirrizzi syndrome;
- •Unable to undergo endoscopic interventions for various reasons;
- •Absolute surgical contraindications, including severe hepatic, renal, cardiac and pulmonary insufficiency, history of cerebral coma and allergy to anesthesia, etc;
- •Presence of ectopic duodenal papilla or congenital pancreaticobiliary malformation;
- •Patients with severe coagulopathy, defined as an International Normalized Ratio (INR) > 1.5 or patients with significant thrombocytopenia (platelet count < 50 × 10⁹/L);
- •Pregnant women;
研究组 & 干预措施
Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy
The patients intend to receive Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy
干预措施: endoscopic transpapillary gallbladder-preserving (Procedure)
ERCP plus Laparoscopic Cholecystectomy
The patients intend to receive ERCP plus laparoscopic cholecystectomy
干预措施: ERCP plus Laparoscopic Cholecystectomy (Procedure)
Conservative Treatment
After removal of common bile duct stone via ERCP,neither ERCP nor laparoscopic cholecystectomy will be carried out to treat cholecystolithiasis.
干预措施: Conservative treatment (Drug)
结局指标
主要结局
Assess the clinical safety of ERCP-GPC ,LC and conservative treatments by evaluating the incidence of intraoperative,short-term and long-term postoperative complications.
时间窗: From enrollment to 3 years after the end of treatment
Compare the rates of intraoperative, early, and late postoperative complications include bile duct injury and recurrence of bile duct stones,etc.
次要结局
- Investigate the differences in efficacy among endoscopic transpapillary gallbladder-preserving cholecystolithotomy , ERCP plus laparoscopic cholecystectomy and conservative treament in managing cholelithiasis with concomitant choledocholithiasis.(From enrollment to 3 years after the end of treatment)
- Conduct a comparative analysis of the economic efficiency of ERCP-GPC , LC and conservative treatment.(From enrollment to 3 years after the end of treatment)