Post living donor liver transplant biliary stricture resolution in primary hepaticojejunostomy vs ERCP stenting - A randomized control study.

Max Super Specialty Hospital1 个研究点分布在 1 个国家目标入组 64 人开始时间: 2026年3月24日最近更新: 2026年2月25日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Max Super Specialty Hospital
入组人数: 64
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

Post living donor liver transplant biliary stricture resolution in primary hepaticojejunostomy vs ERCP stenting A randomized control study. This prospective open label parallel group RCT will randomize 64 adult LDLT recipients with anastomotic biliary strictures 1 1 to primary Roux-en-Y hepaticojejunostomy or ERCP stenting. Primary outcome is 6 month stricture free patency assessed by clinical signs LFT and MRCP.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•Age of the patient more than 18 years.
•LDLT recipients with MRCP proven biliary stricture meeting MDT consensus for eligibility for both ERCP and HJ.
•Patients providing informed consent.
•Patients presenting first time with biliary stricture picture within 1 year post LDLT.
•Patient should be of Indian nationality.

排除标准

•Any other pathology present apart from biliary stricture.
•Non anastomotic biliary strictures.
•Any significant active bile leaks defined by more than Clavien-Dindo IIIA.
•Prior HJ, ERCP or PTBD already done for same stricture.
•Inability/unwillingness to complete follow-up.
•ABO incompatibility transplant patients.
•Likelihood of chronic rejection.
•Refusal for consent.

研究者

发起方

Max Super Specialty Hospital

申办方类型

Private hospital/clinic

责任方

Principal Investigator

主要研究者

Dr Harit Vora

Max Super Specialty Hospital

研究点 (1)

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