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临床试验/CTRI/2026/04/108065
CTRI/2026/04/108065尚未招募不适用

Partially covered vs Fully covered metal stent for endoscopic ultrasound guided hepatico-enterostomy: A randomized control trial

Not applicable1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年4月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
68
试验地点
1

研究概览

简要总结

Biliary obstruction remains one of the most cause for increasing morbidity in patients with carcinoma pancreas, carcinoma gall bladder, cholangiocarcinoma or peri-ampullary carcinoma. Various methods including endoscopic retrograde cholangio-pancreatography (ERCP), endoscopic ultrasound guided biliary drainage (EUS-BD), percutaneous transhepatic biliary drainage (PTBD) etc. can be used. Though traditionally, ERCP was used as a first line modality for drainage of obstructed biliary system, in around 15% to 20% of patients, ERCP attempt gets failed either due to concurrent gastric outlet obstruction or due to difficult biliary canulation. In recent times, EUS guided biliary drainage has emerged as a feasible option in this difficult cases. In a recent meta-analysis, it has shown to be associated with better clinical success (OR, .45; 95% CI, .23-.89; I2 = 0%), fewer postprocedure adverse events (OR, .23; 95% CI, .12-.47; I2 = 57%), and lower rate of reintervention (OR, .13; 95% CI, .07-.24; I2 = 0%) compared to PTBD. Amongst EUS guided biliary drainage, EUS guided hepatico-gastrostomy is feasible even in hilar block as well as in presence of gastric outlet obstruction along with lower rates of stent dysfunction compared to EUS guided choledochoduodenostomy. Technique of EUS guided hepatico-gastrostomy has also undergone more standardised in last decade with better clinical outcomes and lower adverse event rates. Regarding stent selection, dedicated partially covered stent was developed to prevent the blockage of side branches of the biliary ducts. However, the uncovered portion is associated with risk of tissue hyperplasia, stent block by biliary stasis or by food obstruction. Despite initial retrospective studies has shown reduction in risk of segmental cholangitis, risk of recurrent stent obstruction remains high. Recently, Cho S H et al., did a propensity matched analysis of two different types of stent which are being used in EUS guided hepatico-gastrostomy. In that study, patients in whom fully covered stent was used had higher stent patency (76%) compared to patients in whom partially covered metal stent (43%) was used (p=0.03). Moreover, patients in fully covered group required less re-interventions compared to patients in partially covered group (20% vs 38%; p=0.084).(7) However, in absence of any dedicated prospective study, we are planning to perform a randomized controlled trial comparing fully covered vs partially covered metal stent in patients undergoing EUS guided hepatico-gastrostomy.

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

  • Patients with histologically confirmed malignant biliary obstruction
  • Patients with unresectable or locally advanced malignancy
  • Patients in whom ERCP has failed or not feasible.

排除标准

  • Patients with prior biliary ductal plastic or metal stent placement
  • Patients in whom intrahepatic biliary radicles are not dilated
  • Patients with poor (more than ECOG 3) performance status
  • Patients with hilar involvement (less than 2cm from hilum)
  • Patients with uncorrectable coagulopathy
  • Patients with multiple intra-hepatic metastasis (more than 30% of liver parenchyma)
  • Patients who refuse to participate in the trial.

研究者

申办方类型
Other [Not applicable]
责任方
Principal Investigator
主要研究者

Dr Jimil Shah

Postgraduate Institute of Medical Education and Research

研究点 (1)

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