Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere
Conditions
Interventions
Intervention1: Fully covered self expanding metal stent (FC-SEMS): Patients with unresectable maliganacy with biliary obstruction, fulfilling inclusion criteria will be taken up EUS guided hepatico-ga
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed malignant biliary obstruction 2. Patients with unresectable or locally advanced malignancy 3. Patients in whom ERCP has failed or not feasible
Exclusion criteria
Exclusion criteria: 1. Patients with prior biliary ductal plastic or metal stent placement 2. Patients in whom intrahepatic biliary radicles are not dilated 3. Patients with poor (more than ECOG 3) performance status 4. Patients with hilar involvement (less than 2cm from hilum) 5. Patients with uncorrectable coagulopathy 6. Patients with multiple intra-hepatic metastasis (more than 30% of liver parenchyma) 7. Patients who refuse to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of stent dysfunction (due to migration or stent blockage) requiring re-interventionTimepoint: Till mortality or 12 months follow-up whichever is earlier | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical success across both the groupsTimepoint: Till mortality or 12 months follow-up whichever is earlier;2. Procedure related adverse events across both the groupsTimepoint: Till mortality or 12 months follow-up whichever is earlier;3. Time for recurrent biliary obstructionTimepoint: Till mortality or 12 months follow-up whichever is earlier | — |
Countries
India
Contacts
Public ContactDr Jimil Shah
Postgraduate Institute of Medical Education and Research
Outcome results
None listed