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CTRI Number  CTRI/2013/04/003584 [Registered on: 26/04/2013] Trial Registered Prospectively
Last Modified On: 16/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Prospective feasibility trial]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   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 
Scientific Title of Study   EUS-Guided Biliary Drainage in Patients with Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pramod Garg 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Gastroenterology, AIIMS

South
DELHI
110029
India 
Phone  011-26593556  
Fax    
Email  pgarg10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pramod Garg 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Gastroenterology, AIIMS

South
DELHI
110029
India 
Phone  011-26593556  
Fax    
Email  pgarg10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pramod Garg 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Gastroenterology, AIIMS

South
DELHI
110029
India 
Phone  011-26593556  
Fax    
Email  pgarg10@gmail.com  
 
Source of Monetary or Material Support  
AIIMS 
 
Primary Sponsor  
Name  All India Instittue of Medical Sciences 
Address  Ansari Nagar, New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
United States of America  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pramod Garg  All India Institute of Medical Sciences  Department of Gastroenterology, Ansari Nagar
South
DELHI 		 011-26593556

pgarg10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institution Ethics Committee, All India Institute of Medical Sciences  Approved 
JHM-IRB 3  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Inoperable cases of malignant biliary obstruction and with failed ERCP, (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 situ wire using a sphicterotome preloaded with another wire. Sphincterotomy will be done. A stent will be advanced over the wire into the bile duct and deployed under fluoroscopic and endoscopic guidance.  
Comparator Agent  None  No comparotor arm used 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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%
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Safety of the procedure  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
1.Effectiveness
2.Quality of life (QOL)
3.Procedure-related costs
4.Number of required procedures
5.Technical success
6.Stent patency
 		 4 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/04/2013 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/04/2013 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.  
 
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