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Clearing Bile Duct Blockages After Living Donor Liver Transplants: Surgery vs. Stents in a Head-to-Head Trial

Post living donor liver transplant biliary stricture resolution in primary hepaticojejunostomy vs ERCP stenting - A randomized control study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104752
Enrollment
64
Registered
2026-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: T864- Complications of liver transplant Health Condition 2: T864- Complications of liver transplant

Interventions

Intervention1: 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 cholan

Sponsors

Max Super Specialty Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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).Timepoint: 18 months—

Secondary

MeasureTime frame
Technical/clinical success (symptom/lab resolution during hospital stay) Timepoint: Immediate post-procedure (hospital stay) ;Number of procedures needed post-diagnosis Timepoint: 6 months ;Time to stricture resolution Timepoint: 6 months ;Stricture recurrence rate Timepoint: 6 months ;Time to recurrence Timepoint: 6 months ;Procedure-related morbidity (detailed complications) Timepoint: Immediate post-procedure to 6 months—

Countries

India

Contacts

Public ContactDr Harit Vora

Max Super Specialty Hospital

haritvora77@gmail.com9712995155

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026