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临床试验/CTRI/2026/02/104752
CTRI/2026/02/104752尚未招募不适用

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:

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
试验地点
1

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

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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