Health Condition 1: K831- Obstruction of bile duct
Conditions
Interventions
Intervention1: Plastic stent: Arm A (Double DPT):
ERCP with placement of two DPT stents (both 7Fr or 10Fr, as per anatomy)
Control Intervention1: Plastic stent: Arm B (Single DPT)
ERCP with placement
Sponsors
Dr Hemanta Kumar Nayak
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18 to 80 years. 2.Indicated for biliary drainage by ERCP (malignant obstruction. 3.CBD diameter greater than 8 mm. 4.Distal CBD or mid-distal CBD block. 5.Written informed consent.
Exclusion criteria
Exclusion criteria: 1.Previous biliary stenting. 2.Coagulopathy (INR greater than 1.5 or platelets less than 50,000). 3.Severe comorbidities (e.g., advanced cardiac or renal disease). 4.Pregnancy. 5.Altered anatomy preventing standard ERCP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Resolution of cholestasis that is greater than equal to 50% reduction in bilirubin at 7 days or normalization within 4 weeks and improvement in symptoms.Timepoint: At Day 7 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Stent dysfunction rate at 3 months 2.Need for re-intervention 3.Procedure-related complications (bleeding, perforation, pancreatitis, infection) 4.Stent migration or occlusion 5.Patency duration (time to dysfunction) Timepoint: At 3 months and 6 months | — |
Countries
India
Contacts
Public ContactDr Hemanta Kumar Nayak
AIIMS, Bhubaneswar
Outcome results
None listed