| CTRI Number |
CTRI/2026/03/106418 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
14/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
How Safe and Possible Are Living Donor Liver Transplants for People with Acute-on-Chronic Liver Failure? |
|
Scientific Title of Study
|
Clinical Feasibility of Living Donor Liver Transplantation in Patients
with Acute-on-Chronic Liver Failure: An International Multicenter 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 |
Prof Dr Subhash Gupta |
| Designation |
Consultant |
| Affiliation |
Max Super Specialty Hospital |
| Address |
Room- CLBS office, firth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area, Saket, New Delhi, Delhi 110017
South DELHI 110017 India |
| Phone |
9811075683 |
| Fax |
|
| Email |
drSubhash.Gupta@maxhealthcare.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Peush Sahni |
| Designation |
Consultant |
| Affiliation |
Max Super Specialty Hospital |
| Address |
Room- CLBS office, firth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area, Saket, New Delhi, Delhi 110017
South DELHI 110017 India |
| Phone |
9999646488 |
| Fax |
|
| Email |
peush.sahni@maxhealthcare.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Peush Sahni |
| Designation |
Consultant |
| Affiliation |
Max Super Specialty Hospital |
| Address |
Room- CLBS office, firth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area, Saket, New Delhi, Delhi 110017
South DELHI 110017 India |
| Phone |
9999646488 |
| Fax |
|
| Email |
peush.sahni@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KOREA UNIVERSITY COLLEGE OF MEDICINE |
| Address |
Room no-(02841)73, Goryeodae-ro, Seongbuk-gu, Seoul Republic of Korea |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sadhana Shankar |
Dr. Rela Institute and Medical Centre |
HPB surgery and Liver transplant department, DR. RELA INSTITUTE & MEDICAL CENTER, 7, CLC Works Rd, Nagappa Nagar, Chromepet, Chennai, Tamil Nadu 600044 Chennai TAMIL NADU |
9940291975
sadhushankar@gmail.com |
| Dr Subhash Gupta |
Max Super Specialty Hospital |
Room – CLBS Office, fifth floor, West Block, Max Super Speciality Hospital, 1 Press Enclave Marg, Saket Institutional Area, Saket, New Delhi, Delhi 110017 South DELHI |
9811075683
drSubhash.Gupta@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr Rela Institute and Medical Center |
Approved |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K721||Chronic hepatic failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
ACLF patients who underwent LDLT between 2013 and 2023
Definition of ACLF: A clinical syndrome characterized by acute decompensation in patients with chronic liver disease (typically cirrhosis), accompanied by failure of one or more major organ systems |
|
| ExclusionCriteria |
| Details |
Patients with fulminant hepatic failure or acute liver failure without underlying chronic liver disease
Patients lost to follow-up within 1 year after LDLT
Patients with incomplete or insufficient medical records, making data analysis impossible
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Short-term and long-term clinical outcomes of ACLF patients undergoing LDLT and assess its clinical efficacy.
|
Research Planning & IRB Approval: 2 months
Data Collection & Analysis: 9 months
Results Reporting & Manuscript Writing: 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Risk factors identified for futility (defined as death within 3 months post-transplant or in-hospital mortality) in ACLF patients receiving LDLT and to develop predictive models for transplant outcomes. |
Research Planning & IRB Approval: 2 months
Data Collection & Analysis: 9 months
Results Reporting & Manuscript Writing: 3 months
|
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
04/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/04/2026 |
| 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)
|
Open to Recruitment |
| 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
|
This is an international multicenter retrospective study evaluating the
clinical feasibility and outcomes of living donor liver transplantation (LDLT)
in patients with acute-on-chronic liver failure (ACLF). The study will analyze
medical records of ACLF patients who underwent LDLT between 2013 and 2023
across multiple participating institutions, including Max Super Specialty
Hospital, Saket. The primary objective is to assess short-term and long-term
clinical outcomes, including graft and patient survival rates at 90 days, 1
year, and 3 years post-transplantation. Secondary objectives include
identifying risk factors for futility (death within 3 months or in-hospital
mortality) and developing predictive models for transplant outcomes. Data will
be classified according to ACLF severity (Grade 1, 2, 3) using EASL-CLIF
criteria, and statistical analysis will be performed to compare outcomes and
validate predictive models. The study poses no direct risk to patients as it
involves retrospective analysis of anonymized medical records, ensuring
confidentiality and compliance with ethical standards. The findings will
contribute to evidence-based guidelines for LDLT in ACLF patients and improve
personalized prognosis assessment and survival rates. |