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CTRI Number  CTRI/2025/04/083940 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 28/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Outcome of endosopic ultrasound guided biliary stenting to relieve jaundice due to cancer. 
Scientific Title of Study   Feasibility study of EUS-guided dual direction biliary drainage with a long, small diameter partially covered metal stent 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinay Dhir 
Designation  Chairman, Department of Gastroenetrology, Institute of Digestive and Liver Care, S. L. Raheja hospital - A Fortis associate 
Affiliation  Institute of Digestive and Liver Care 
Address  Institute of Digestive and Liver Care, 5th floor, S. L. Raheja hospital - A Fortis associate, Mahim, Mumbai.

Mumbai
MAHARASHTRA
400016
India 
Phone  9819920266  
Fax    
Email  vinaydhir@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vinay Dhir 
Designation  Chairman, Department of gastroenterology, , Institute of Digestive and Liver Care, S. L. Raheja hospital - A Fortis associate 
Affiliation  Institute of Digestive and Liver Care 
Address  Institute of Digestive and Liver Care, 5th floor, S. L. Raheja hospital - A Fortis associate, Mahim, Mumbai.

Mumbai
MAHARASHTRA
400016
India 
Phone  9819920266  
Fax    
Email  vinaydhir@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vinay Dhir 
Designation  Chairman, Department of gastroenterology, Institute of Digestive and Liver Care, S. L. Raheja hospital - A Fortis associate 
Affiliation  Institute of Digestive and Liver Care 
Address  Institute of Digestive and Liver Care, 5th floor, S. L. Raheja hospital - A Fortis associate, Mahim, Mumbai.

Mumbai
MAHARASHTRA
400016
India 
Phone  9819920266  
Fax    
Email  vinaydhir@gmail.com  
 
Source of Monetary or Material Support  
EUS Educational foundation, Mumbai. A 905, Ashok gardens, T J road, Sewri, Mumbai 400015 
 
Primary Sponsor  
Name  EUS Educational foundation 
Address  A 905, Ashok gardens, T J Road, Sewri, Mumbai 400015 
Type of Sponsor  Other [Non-profit foundation for Endoscopy research] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vinay Dhir  Department of gastroenterology, Institute of Digestive and Liver Care  5th floor, S. L. Raheja Hospital - A Fortis associate, Mahim, Mumbai 400016
Mumbai
MAHARASHTRA 
9819920266

vinaydhir@gamil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional review board, S.L.Raheja (A Fortis Associate)hospital,Mahim(West),Mumbai 400016  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Biliary drainage  Using a curved linear array echoendoscope (Olympus GF-UCT 180, Tokyo, Japan), the left hepatic duct will be identified from the proximal gastric body and punctured with a 19-gauge FNA needle (EZ Shot 3 plus [Olympus Medical, Tokyo, Japan]). Colour Doppler will be used to detect any intervening vessel. After confirming bile aspiration, contrast will injected to obtain a cholangiogram. A hydrophilic 0.025/0.035-inch guidewire will be advanced into the duodenum via the papilla. The needle will be removed followed by the track dilation by using a 6F cystotome. Guidewire will be exchanged to a stiff wire (0.025-inch guidewire (VisiGlide [Olympus Medical]), followed by cystotome removal and passage of the ArVi stent. The position of the stent in the duodenum will be confirmed by contrast injection, and that in the stomach will be confirmed endoscopically. If the middle of the stent is not seen to expand on fluoroscopy, a 4mm balloon will be used to dilate the stent. The procedure will taken approximately 60mins.  
Comparator Agent  NIL  Single arm study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Unresectable malignant biliary obstruction (malignant distal biliary obstruction and Type I hilar block) with failed ERCP 
 
ExclusionCriteria 
Details  Previous history of ERCP with plastic or metal stent in-situ or PTBD, hilar block II-IV, patients on neo-adjuvant chemotherapy, pregnancy, participation in another investigational trial within 180 days, bleeding tendencies, ascites and benign biliary strictures 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Technical and clinical success  2 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events in the from of stent migration, stent block, cholangitis  4 weeks  
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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   Phase 2 
Date of First Enrollment (India)   21/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vinaydhir@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

EUS-guided biliary drainage is an effective modality for management of malignant obstructive jaundice. Randomized studies and meta-analyses have shown EUS-BD to be equivalent to ERCP in patients with distal malignant obstructive jaundice. The main advantage of EUS-BD is its ability to access the biliary tree from the stomach, duodenum, and also the papilla. The two main routes of drainage are trans-luminal and Tans-papillary. The trans-luminal route creates an anastomosis between the bile duct and duodenum (choledocho-duodenostomy, CDS) or between stomach and left intrahepatic biliary radical( Hepatico-gastrostomy, HGS). The trans-papillary route accesses the biliary system from the left intra-hepatic biliary radical, and places a stent across the papilla (antegrade, AG). A randomized study and a meta analysis has shown CDS and HGS to be equally effective. In a recent randomized study, we have shown that trans-papillary route results in longer stent patency. We have postulated that areas of bile stasis in the distal bile duct may promote early stent block in CDS and HGS. Recent studies have shown that a combination of HGS and AG produce longer stent patency compared to HGS alone. This may be due to better drainage from the distal bile duct by the trans-papillary stent, thus avoiding stasis. A combination of HGS and AG requires two stents, and takes longer procedure time. It is possible that a single long stent combining properties of both HGS and AG will provide longer stent patency and will be easier to place.

Hypothesis

We hypothesized that a long stent extending from proximal stomach across the left intrahepatic biliary radical, liver hilum, common bile duct and papilla into the duodenum should provide long term relief of malignant obstructive jaundice. We also hypothesized that since this stent has dual bile drainage in the stomach as well as duodenum, a smaller diameter than the existing stent may be sufficient.

 
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