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A trial to see a new technique to drain bile in patients whom standard methods of biliary drainage have failed in patients of biliary tract cancer

EUS-Guided Biliary Drainage in Patients with Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/04/003584
Enrollment
20
Registered
2013-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Inoperable cases of malignant biliary obstruction and with failed ERCP Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: EUS guided biliary drainage: EUS guided biliary duct will be punctured, guidewire will be advanced through the needle into the bile duct. The bile duct will be cannulated next to the in

Sponsors

All India Instittue of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Consecutive adult patients (18-80 years of age) with jaundice due to inoperable (by EUS and/or CT criteria or due to health status) malignant distal (more than 2cm distal to hilum) biliary obstruction and who have failed prior ERCP attempt. Failure is considered to be 2 unsuccessful attempts, according to each institutionâ??s definition of â??failedâ?? procedure (patients may be consented for EGBD prior to repeat ERCP due to higher likelihood of failure). One failure at outside institution and one failure at our institution can be considered as total of two failures. 2. Ability to give informed consent

Exclusion criteria

Exclusion criteria: 1. Unable to give informed consent 2. Life expectancy 3. Pregnant or breastfeeding women 4. Acute gastrointestinal bleeding 5. Coagulopathy defined by prothrombin time 50 sec, or INR > 1.5), on chronic anticoagulation, or platelet count 6. Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy 7. Prior total gastrectomy, Roux-en-Y gastric bypass, esophagectomy and sleeve gastrectomy 8. Cirrhosis with portal hypertension, varices, and/or ascites 9. Liver metastases burden > 30%

Design outcomes

Primary

MeasureTime frame
Safety of the procedureTimepoint: 1 week—

Secondary

MeasureTime frame
1.Effectiveness 2.Quality of life (QOL) 3.Procedure-related costs 4.Number of required procedures 5.Technical success 6.Stent patency Timepoint: 4 weeks—

Countries

India, United States of America

Contacts

Public ContactDr Pramod Garg

AIIMS, New Delhi

pgarg10@gmail.com011-26593556

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026