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临床试验/CTRI/2025/04/083940
CTRI/2025/04/083940尚未招募2 期

Feasibility study of EUS-guided dual direction biliary drainage with a long, small diameter partially covered metal stent

EUS Educational foundation1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年4月21日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
16
试验地点
1
主要终点
Technical and clinical success

研究概览

简要总结

EUS-guided biliary drainage is an effective modality for management of malignant obstructive jaundice. Randomized studies and meta-analyses have shown EUS-BD to be equivalent to ERCP in patients with distal malignant obstructive jaundice. The main advantage of EUS-BD is its ability to access the biliary tree from the stomach, duodenum, and also the papilla. The two main routes of drainage are trans-luminal and Tans-papillary. The trans-luminal route creates an anastomosis between the bile duct and duodenum (choledocho-duodenostomy, CDS) or between stomach and left intrahepatic biliary radical( Hepatico-gastrostomy, HGS). The trans-papillary route accesses the biliary system from the left intra-hepatic biliary radical, and places a stent across the papilla (antegrade, AG). A randomized study and a meta analysis has shown CDS and HGS to be equally effective. In a recent randomized study, we have shown that trans-papillary route results in longer stent patency. We have postulated that areas of bile stasis in the distal bile duct may promote early stent block in CDS and HGS. Recent studies have shown that a combination of HGS and AG produce longer stent patency compared to HGS alone. This may be due to better drainage from the distal bile duct by the trans-papillary stent, thus avoiding stasis. A combination of HGS and AG requires two stents, and takes longer procedure time. It is possible that a single long stent combining properties of both HGS and AG will provide longer stent patency and will be easier to place.

Hypothesis

We hypothesized that a long stent extending from proximal stomach across the left intrahepatic biliary radical, liver hilum, common bile duct and papilla into the duodenum should provide long term relief of malignant obstructive jaundice. We also hypothesized that since this stent has dual bile drainage in the stomach as well as duodenum, a smaller diameter than the existing stent may be sufficient.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Unresectable malignant biliary obstruction (malignant distal biliary obstruction and Type I hilar block) with failed ERCP.

排除标准

  • Previous history of ERCP with plastic or metal stent in-situ or PTBD, hilar block II-IV, patients on neo-adjuvant chemotherapy, pregnancy, participation in another investigational trial within 180 days, bleeding tendencies, ascites and benign biliary strictures.

结局指标

主要结局

Technical and clinical success

时间窗: 2 weeks

次要结局

  • Adverse events in the from of stent migration, stent block, cholangitis(4 weeks)

研究者

发起方
EUS Educational foundation
申办方类型
Other [Non-profit foundation for Endoscopy research]

研究点 (1)

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