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Clinical Trials/CTRI/2024/02/062850
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

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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