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临床试验/CTRI/2024/12/077586
CTRI/2024/12/077586尚未招募2/3 期

Comparison of percutaneous transhepatic biliary drainage (PTBD) versus endoscopic ultrasonography (EUS) guided hepaticogastrostomy (HGS) in malignant hilar biliary obstruction: a randomized controlled trial

Jayanta Samanta1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2024年12月16日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
95
试验地点
1
主要终点
Rate of clinical success between the two arms of EUS-HGS and PTBD

研究概览

简要总结

The primary treatment of jaundice secondary to a malignancy hilar biliary obstruction (MHBO) is stenting during endoscopic retrograde cholangiopancreatography. However, ERCP can fail or sometimes not feasible due to duodenal obstruction or  difficulty in passing guidewire across the stricture. In such cases, percutaneous transhepatic biliary drainage (PTBD) is most commonly performed for decades and is recommended second line in most guidelines.  EUS guided biliary drainage procedures have been recognized as an appealing alternative to PTBD. Amongst them, EUS Hepaticogastrostomy (HGS) is the only technically possible method available for MHBO. Both EU-HGS and PTBD are technically available alternatives in MHBO cases with failed ERCP. But in literature, there are only retrospective studies with heterogenous cohort. Hence, we plan to conduct a prospective randomized study with a homogenous cohort comparing the outcomes between EUS guided hepaticogastrostomy and PTBD, as a second line management for biliary drainage in MHBO cases with failed primary ERCP.

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 90.00 Year(s)(—)
性别
All

入选标准

  • malignant hilar biliary obstruction with type I and II block requiring biliary drainage Failed or non-feasible ERCP cases informed consent.

排除标准

  • Malignant Hilar obstruction with type IIIa, IIIb and IV block benign cause of biliary obstruction atrophied left lobe unfit for endoscopic procedure Non-correctable coagulopathy, thrombocytopenia pregnant female.

结局指标

主要结局

Rate of clinical success between the two arms of EUS-HGS and PTBD

时间窗: at 1 month post procedure

次要结局

  • 1. To compare technical success between both the groups(2. Re-intervention rates between both the groups)

研究者

申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Jayanta Samanta

Postgraduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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