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
- Conditions
- Health Condition 1: null- Inoperable cases of malignant biliary obstruction and with failed ERCPHealth Condition 2: O- Medical and Surgical
- Registration Number
- CTRI/2013/04/003584
- Lead Sponsor
- All India Instittue of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
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
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
- Secondary Outcome Measures
Name Time Method