CTRI/2024/02/062850
Not yet recruiting
Phase 3
EUS versus ERCP guided biliary drainage for primary palliation of malignant biliary obstruction: A Randomized Clinical Trial - nil
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: K831- Obstruction of bile duct
- Sponsor
- All India Institute of Medical Sciences Rishikesh
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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