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Study to compare the difference between the outcomes of liver transplant between usage of synthetic graft(PTFE) vs native tissue graft(portal vein)

Randomized Controlled Trial to compare Early Postoperative Outcomes of Polytetrafluoroethylene Graft Vs. Native Recipient Portal Vein fro Middle Hepatic Vein Reconstruction in the Recipient following Live Donor Liver Transplantation - RePoVer Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/11/016315
Enrollment
60
Registered
2018-11-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- DECOMPENSATED CHRONIC LIVER DISEASE PATIENTS REQUIRING LIVER TRANSPLANTATION

Interventions

Intervention1: POLYTETRAFLUOROEHTYLENE GRAFT: USE OF PTFE GRAFT FOR RECONSTRUCTION OF MIDDLE HEPATIC VEIN IN THE MODIFIED RIGHT LOBE GRAFT IN A LIVE DONOR LIVER TRANSPLANTATION Control Intervention1:

Sponsors

Amrita Institute of Medical Sciences Research Centre
Lead Sponsor
DEPARTMENT OF GI SURGERY AND LIVER TRANSPLANTATION
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: ADULT to ADULT LIVE DONOR LIVER TRANSPLANT PATIENTS with Decompensated Liver Disease (Acute/Subacute/Chronic) Live Donor suitable for Right lobe donation with 1. Functional Liver Reserve > 30% 2. Adequate Segment 4 drainage to the Left Hepatic Vein 3. Steatosis < 20% assesses by Plain CT

Exclusion criteria

Exclusion criteria: PORTAL VEIN THROMBOSIS IN THE RECIPIENT HEPATOCELLULAR CARCINOMA IN THE RECIPIENT ABO Incompatible Transplants DONOR - TYPE II or TYPE III Portal vein anatomy

Design outcomes

Primary

MeasureTime frame
GRAFT PATENCY RATE assessed by DUPLEX ULTRASONOGRAM and confirmed with cross sectional imaging either CT or MRI in the event of thrombosis detected by DuplexTimepoint: First two weeks (daily doppler in the first week and alternate day doppler in the second week) at weekly intervals till 90 days—

Secondary

MeasureTime frame
GRAFT FUNCTION : EARLY ALLOGRAFT DYSFUNCTION PRIMARY NON FUNCTION SMALL FOR SIZE DYSFUNCTION Timepoint: First two weeks;ICU Stay Hospital Stay 90 Day mortality Between patent vs thrombosed group Sepsis specific mortality 90 day mortalityTimepoint: 90 days ;MORBIDITY : Complications : Infections (intra-abdominal and blood borne) Vascular : Hepatic Artery thrombosis Portal vein thrombosis Biliary : Bile leak Immunological : Acute cellular rejection Interventions : Reexploration Percutaneous drainage of collectionTimepoint: First 2 weeks—

Countries

India

Contacts

Public ContactSUDHINDRAN SURRENDRAN

DEPARTMENT OF G.I SURGERY AND ORGAN TRANSPLANTATION

sudhisalini@icloud.com919388623851

Outcome results

None listed

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