| CTRI Number |
CTRI/2026/02/104752 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clearing Bile Duct Blockages After Living Donor Liver Transplants: Surgery vs. Stents in a Head-to-Head Trial |
|
Scientific Title of Study
|
Post living donor liver transplant biliary stricture resolution in primary
hepaticojejunostomy vs ERCP stenting - A randomized control study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harit Vora |
| Designation |
DrNB Senior Resident |
| Affiliation |
Max Super Specialty Hospital |
| Address |
Room no- CLBS office, fifth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area,
South
DELHI
South
DELHI
110017
India |
| Phone |
9712995155 |
| Fax |
|
| Email |
haritvora77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harit Vora |
| Designation |
DrNB Senior Resident |
| Affiliation |
Max Super Specialty Hospital |
| Address |
Room no- CLBS office, fifth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area,
South
DELHI
DELHI
110017
India |
| Phone |
9712995155 |
| Fax |
|
| Email |
haritvora77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harit Vora |
| Designation |
DrNB Senior Resident |
| Affiliation |
Max Super Specialty Hospital |
| Address |
Room no- CLBS office, fifth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area,
South
DELHI
DELHI
110017
India |
| Phone |
9712995155 |
| Fax |
|
| Email |
haritvora77@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Max Super Specialty Hospital |
| Address |
Room- CLBS office, fifth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area, S
South
DELHI
110017
India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Dr Peush Sahni |
Max Super Specialty Hospital |
Room number- Centre for Liver and Biliary Sciences (CLBS) department office, fifth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area, South
DELHI
110017
India
South
DELHI |
9999646488
peush.sahni@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T864||Complications of liver transplant, (2) ICD-10 Condition: T864||Complications of liver transplant, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endoscopic Retrograde Cholangiopancreatography assisted stenting |
Ercp with side viewing endoscope with balloon dilatation with 6-10mm, with/without sphincterotomy: 1 stent initially in each duct, increasing to 4+ stents by week 12, removal/ exchange at week 24 depending on stricture resolution. |
| Intervention |
Open Roux-en-Y hepaticojejunostomy
|
Open surgical reconstruction: side-to-side duct-to-mucosa anastomosis with PDS 4-0/5-0/6-0, jejuno-jejunostomy 40-50cm distal, intraoperative cholangiogram
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age of the patient more than 18 years.
2. LDLT recipients with MRCP proven biliary stricture meeting
MDT consensus for eligibility for both ERCP and HJ.
3. Patients providing informed consent.
4. Patients presenting first time with biliary stricture picture within
1 year post LDLT.
5. Patient should be of Indian nationality. |
|
| ExclusionCriteria |
| Details |
1. Any other pathology present apart from biliary stricture.
2. Non anastomotic biliary strictures.
3. Any significant active bile leaks defined by more than Clavien-Dindo IIIA.
4. Prior HJ, ERCP or PTBD already done for same stricture.
5. Inability/unwillingness to complete follow-up.
6. ABO incompatibility transplant patients.
7. Pregnancy.
8. Likelihood of chronic rejection.
9. Refusal for consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome of the study will be to determine the patency rates at 6 months after
procedure. This will be determined by 3 parameters- clinical signs and symptoms
assessment, laboratory parameters (liver function test) and radiological imaging
(MRCP). |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Technical/clinical success (symptom/lab resolution during hospital stay) |
Immediate post-procedure (hospital stay)
|
| Number of procedures needed post-diagnosis |
6 months
|
| Time to stricture resolution |
6 months
|
| Stricture recurrence rate |
6 months
|
| Time to recurrence |
6 months
|
| Procedure-related morbidity (detailed complications) |
Immediate post-procedure to 6 months
|
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
24/03/2026 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
Post living donor liver transplant biliary stricture resolution in primary hepaticojejunostomy vs ERCP stenting A randomized control study. This prospective open label parallel group RCT will randomize 64 adult LDLT recipients with anastomotic biliary strictures 1 1 to primary Roux-en-Y hepaticojejunostomy or ERCP stenting. Primary outcome is 6 month stricture free patency assessed by clinical signs LFT and MRCP.
|