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

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2013/04/003584
• Lead Sponsor: All India Instittue of Medical Sciences

Brief Summary

EUS guided biliary drainage (EGBD) is a less invasive approach compared to radiologic or surgical methods of biliary drainage. This study is a done to prove the feasibility of EGBD with the future goal of comparing it with percutaneous transhepatic biliary drainage in a randomized trial.

The study hypothesis is that EGBD is equally effective and safe to PTBD and is associated with better quality of life than PTBD in patients with inoperable malignant distal biliary obstruction who have failed prior ERCP. EGBD may be associated with decreased procedure related costs. Patients who undergo PTBD usually require multiple procedures for stent exchange/ upsize.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-29
• Last Update Posted: 2019-11-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

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 institution’s definition of “failed†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

1.Unable to give informed consent 2.Life expectancy < 1month 3.Pregnant or breastfeeding women 4.Acute gastrointestinal bleeding 5.Coagulopathy defined by prothrombin time < 50% of control; PTT > 50 sec, or INR > 1.5), on chronic anticoagulation, or platelet count <50,000 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%.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of the procedure	1 week

Secondary Outcome Measures

Name	Time	Method
1.Effectiveness	2.Quality of life (QOL)

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences

🇮🇳South, DELHI, India

Dr Pramod Garg

Principal investigator

011-26593556

pgarg10@gmail.com