A Multi-center, Randomized, Open-label, Prospective, Compared, Investigator-Initiated and Feasibility Clinical Study to evaluate the safety and efficacy of ERCP procedure stenting Uncovered SEMS after balloon dilation-laser ablation using Nd;YAG Laser surgical ‘Inbris’ compared to ERCP procedure stenting Uncovered SEMS in patients with unresectable malignant extrahepatic biliary stricture

Inha University Hospital0 个研究点目标入组 14 人开始时间: 待定最近更新: 2023年5月30日

适应症

试验速览

暂无简介。

•1. Adult males and females aged 19 years or older who voluntarily gave written consent after hearing the explanation of the purpose and method of this clinical trial and the foreseeable risks and inconveniences caused by the clinical trial
•2. When malignant extrahepatic bile duct stricture is confirmed histopathologically
•? Malignant bile duct stenosis due to bile duct cancer, gallbladder cancer, pancreatic cancer, or other malignant tumors is also applicable.
•3. Malignant extrahepatic bile duct stenosis that cannot be surgically resected, a high-risk group for surgery, or the patient does not want surgery
•4. When the bile duct stricture segment is at least 1 cm away from the port of the liver
•5. If the predicted survival period is more than 3 months as of the screening date
•6. If KPS (Karnofsky Performance Status) = 60%
•7. If you are willing to participate in a clinical trial, adhere to treatment and procedures, and visit the hospital for all follow-up evaluations

•1. Those who are unsuitable or uncooperative with endoscopic retrograde cholangio-pancreatography (ERCP)
•2. In case of uncontrolled blood clotting disorder (Criteria for blood clotting disorder: PT-INR (Prothrombin Time-International Normalized Ratio) > 1.5, Platelet Count < 60,000/mm3)
•3. Cases with altered bile duct anatomy due to surgical operation
•4. A person who cannot stop taking dual anti-platelet agent
•5. Patients with decompensated cirrhosis of grade C based on the Child-Pugh Class
•6. Patients with end-stage renal failure
•7. If you are pregnant or lactating
•8. Implanted cardiac pacemaker
•9. Patients with malignant tumors not related to bile duct stricture
•10. In case of intraductal papillary neoplasm of the bile duct (IPN-B), a precancerous lesion of cholangiocarcinoma
•11. Those who are currently participating in other clinical trials or who have participated in other clinical trials within 90 days of the screening date
•12. Other cases where the investigator judges that participation in the clinical trial is inappropriate due to ethical reasons or may affect the results of the clinical trial

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