Health Condition 1: null- Distal biliary obstruction
Conditions
Interventions
None listed
Sponsors
VINAY DHIR
Eligibility
Inclusion criteria
Inclusion criteria: Consecutive patients with jaundice due to inoperable (by CT and/or EUS criteria or due to poor health status) malignant distal (more than 3cm distal to liver hilum) biliary obstruction
Exclusion criteria
Exclusion criteria: Age b. Unable to give informed consent c. Pregnant or breast feeding women d. Coagulopathy (INR >1.6, Thrombocytopenia with platelet count e. Altered surgical anatomy (Billroth II/Roux-en-Y, gastric bypass) f. Liver metastasis burden >30% g. Cirrhosis with portal hypertension and/or ascites. h. Duodenal stricture that preclude passage of the scope to the duodenum despite adequate dilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rates of clinical adverse events between patients undergoing EUS-BD and ERCP for distal malignant biliary obstruction Timepoint: Review will be at 2, 4, 6, 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment success: Clinical success is defined as decrease in direct bilirubin by 50% at 2 weeks and to below 3 mg/dL at 4 weeks (level that enables administration of chemotherapy).Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactVinay Dhir
Global Hospital, Mumbai
Outcome results
None listed