| CTRI Number |
CTRI/2026/04/108017 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
20/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Developing a tool to rate how complex a living donors liver graft is, helping to predict short-term results after living donor liver transplant |
|
Scientific Title of Study
|
Development and Validation of a Living Donor Graft Complexity Score to Predict Early Outcomes After LDLT PRECISE-LDLT Study.Predict Early Outcomes After Living Donor Liver Transplantation |
| 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 Sonal Asthana |
| Designation |
Lead Consultant- HPB and Liver transplant Surgery |
| Affiliation |
Aster CMI |
| Address |
43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA
560092
India |
| Phone |
09686976379 |
| Fax |
|
| Email |
drsonal.asthana@asterhospital.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Asthana |
| Designation |
Lead Consultant- HPB and Liver transplant Surgery |
| Affiliation |
Aster CMI |
| Address |
43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
KARNATAKA
560092
India |
| Phone |
09686976379 |
| Fax |
|
| Email |
drsonal.asthana@asterhospital.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Asthana |
| Designation |
Lead Consultant- HPB and Liver transplant Surgery |
| Affiliation |
Aster CMI |
| Address |
43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
KARNATAKA
560092
India |
| Phone |
09686976379 |
| Fax |
|
| Email |
drsonal.asthana@asterhospital.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aster CMI Hospital |
| Address |
43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092 |
| 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 Sonal Asthana |
Aster CMI Hospital |
43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA |
09686976379
drsonal.asthana@asterhospital.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aster CMI Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K768||Other specified diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
•Liver Transplant recipients (Living and Deceased)
• Patients with Hepato-cellular carcinoma
• All Chronic liver disease patients
• All Acute liver disease patients |
|
| ExclusionCriteria |
| Details |
• All vulnerable patient population(Pregnant,Mentally unstable etc)
• Other organ transplant recipients( Heart,Lung,Kidney) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop and validate a Living Donor Graft Complexity Score for LDLT that predicts early post-transplant outcomes. |
3months,6 months ,12 months, 2 years ,5 years ,10 years, 15 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To assess the association between graft complexity score and:
• Early allograft dysfunction (EAD)
• Biliary complications
• Vascular complications
• ICU and hospital length of stay
• To stratify LDLT recipients into low-, intermediate-, and high-complexity risk groups
• To evaluate the discriminatory performance of the score for predicting early graft failure and mortality
• To provide a simple, clinically applicable tool for donor assessment and surgical planning |
3 months |
|
|
Target Sample Size
|
Total Sample Size="8000"
Sample Size from India="8000"
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)
|
17/04/2026 |
| 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="4"
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
|
Currently,
no standardized, LDLT-specific graft complexity score exists, leaving
clinical assessment subjective and center-dependent, reliant on
surgeon experience rather than objective metrics. A simple,
objective, reproducible complexity score—incorporating anatomical
variants, volumetric parameters, steatosis grading, and donor
factors—is urgently needed to standardize preoperative donor
assessment, accurately predict early outcomes, facilitate
risk-stratified surgical planning, and improve informed counseling
for both recipients and living donors in high-LDLT volume regions. |