CTRI/2024/02/062850尚未招募Phase 3 4
EUS versus ERCP guided biliary drainage for primary palliation of malignant biliary obstruction: A Randomized Clinical Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To compare the technical success of ERCP and EUS guided biliary drainage for primary drainage of unresectable subhilar malignant biliary obstruction. Technical success is defined as placement of metal stent and visual confirmation of flow of bile immediately after placing stent.
研究概览
简要总结
The trial is to compare the technical success rate of both ERCP guided and EUS guided biliary drainage in patients of malignant inoperable biliary obstruction. additional objectives will also be studied like stent patency rate of metal stents between two groups and stent dysfunction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Radiological diagnosis (with or without pathological confirmation) of malignancy and presence of a malignant subhilar (at least 2cm distal to hilum) biliary obstruction and dilation of the upstream bile duct that is unresectable or the patient is inoperable due to high surgical risk as decided by the treating surgeon.
排除标准
- •1-Age less than 18 years 2-Hilar biliary obstruction 3-Grade 3 cholangitis 4-Poor performance status 5-Pregnancy 6-Post biliary sphincterotomy status 7-Prior duodenal self-expanding metal stent 8-Liver metastasis of more than 30 % of liver volume 9-Gastric outlet obstruction 10-Prior ERCP and EUS with a stent in situ 11-Moderate to severe ascites on imaging.
结局指标
主要结局
To compare the technical success of ERCP and EUS guided biliary drainage for primary drainage of unresectable subhilar malignant biliary obstruction. Technical success is defined as placement of metal stent and visual confirmation of flow of bile immediately after placing stent.
时间窗: baseline (preprocedure)and immediately after placement of stent
次要结局
- 1-Procedure time-time (in mins) from the puncture of the bile duct to stent placement in the EUS-BD group, & from the time of biliary cannulation to stent placement in the ERCP group.(2-Clinical success- improvement in T-Bilirubin to less than 50% of the highest pretreatment values within 14 days after stent placement or less than 25% of the highest pretreatment values within 4 weeks and/or resolution of cholangitis if present preprocedure.)
研究者
Rahul Yadav
AIIMS RISHIKESH
研究点 (1)
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