Clinical utility of endobiliary radiofrequency ablation for the treatment of malignant extrahepatic biliary stricture: A multicenter randomized controlled trial
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 83
研究概览
简要总结
This prospective, multicenter, randomized controlled clinical study compared the clinical utility of endoscopic biliary radiofrequency ablation combined with metallic stent implantation (test group) and stent implantation alone (control group) in patients with unresectable malignant extrahepatic bile duct. The goal was to do this. lim. Over a period of approximately 4 years from 2019 to April 2023, 82 out of 147 eligible subjects were registered, recording a registration rate of 56.5%. Despite extending the study period several times, the registration rate for clinical participation was low and the number of subjects registered was slow. Due to poor performance, it was judged impossible to reach the target number of subjects in the future, and the study was terminated in early April 2023 after consultation with all co-researchers. 1. Number of subjects registered at early termination of clinical trial: 39 in test group, 43 in control group 2. Total complication rate in the early stage of the procedure: 69% in the test group, 62% in the control group. 3. Initial mortality rate after endoscopic procedure: 0% in both groups 4. Average stent opening period: 75 days in the experimental group, 102 days in the control group. 5. Average survival period: test group 60 days, control group 196 days
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 100(Year)（—）
- 性别
- All
入选标准
- •1. Malignant extrahepatic bile duct stricture (histopathologically confirmed or malignant bile duct stenosis is judged through clinical course). If surgical resection is not possible, or high-risk surgical operation or patient does not want surgery
- •2. Malignant biliary stricture caused by cholangiocarcinoma, gallbladder cancer and pancreatic cancer
- •3. The bile duct stricture is at least 1 cm away from the hilar bile duct
- •4. The predicted survival period is more than 3 months
- •5. Performance status: ECOG 0 ~ 1 or Karnofsky performance> 80%
- •6. patient who agree to participate in this study and complete the patient consent form
排除标准
- •1. Inadequate for ERCP
- •2. More than 14 days after ERCP, EST, or ERBD / ENBD
- •3. Uncontrolled blood coagulation disorders (PT-INR> 1.5; normal 0.85-1.25, platelet count <60,000 / mm3; normal 150,000-450,000 / mm3)
- •4. Patients who can not stop taking dual anti-platelet agents (eg, patients with coronary artery disease undergoing coronary vascular stenting within one year)
- •5. Child C grade uncompensated cirrhosis patient
- •6. End-stage renal failure
- •7. ultered bile duct anatomy due to previous surgical operation
- •8. Failure of duodenal access to the duodenal papilla or failure of selective bile duct cannulation
- •9. pregnancy or lactating
- •10. patient who disagree with participation in this study
- •11. Uncooperative patients during ERCP procedure
- •12. Patients with poor performance status
- •13. Ampullary cancer
- •14. Intraductal papillary mucinous neoplasm in bile duct (IPN-B)