Comparison of Endoscopic ultrasound and ERCP guided biliary drainage
Phase 3
- Conditions
- Health Condition 1: K831- Obstruction of bile duct
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
11-Moderate to severe ascites on imaging
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: baseline (preprocedure)and immediately after placement of stent
- Secondary Outcome Measures
Name Time Method