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
|
|
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
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vinaydhir@gmail.com].
- 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.
- 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. |