| CTRI Number |
CTRI/2025/12/099367 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare risk of Post operative biliary complications in Liver transplant recipients in MRCP vs Non MRCP group in Living liver donors |
|
Scientific Title of Study
|
Magnetic Resonance Cholangiopancreatography in Living Liver Donors and its relationship with post operative Recipient biliary complications - Open Label Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Atul Renjit |
| Designation |
Senior Resident Hepatopancreaticobiliary surgery and Liver Transplantation |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of HPB surgery, 4th floor Phase 1
ILBS hospital, D1, Sector D, Vasant Kunj, New Delhi, 110070
South West
DELHI
110070
India |
| Phone |
1146300000 |
| Fax |
|
| Email |
atulrenjit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh Sadashiv Patil |
| Designation |
Associate Professor, Department of HPB surgery and Liver transplant |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of HPB surgery, 4th floor Phase 1
ILBS hospital, D1, Sector D, Vasant Kunj, New Delhi, 110070
South West
DELHI
110070
India |
| Phone |
1146300000 |
| Fax |
|
| Email |
dr.nils.p@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilesh Sadashiv Patil |
| Designation |
Associate Professor, Department of HPB surgery and Liver transplant |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of HPB surgery, 4th floor Phase 1
ILBS hospital, D1, Sector D, Vasant Kunj, New Delhi, 110070
Kozhikode
DELHI
110070
India |
| Phone |
1146300000 |
| Fax |
|
| Email |
dr.nils.p@gmail.com |
|
|
Source of Monetary or Material Support
|
| ILBS Hospital, D1, Vasant Kunj, New Delhi |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
ILBS hospital, D1 , Sector D, Vasant Kunj, New Delhi, 110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Atul Renjit |
Institute of Liver and Biliary Sciences |
Department of HPB surgery, 4th floor , Phase 1,
ILBS Hospital, D1, Sector D, Vasant Kunj, New Delhi, India 110070
New Delhi
DELHI |
9632060230
atulrenjit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Institute of Liver and Biliary Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Voluntary Healthy Liver Donors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MRCP |
MRCP will be done single time at baseline along with Liver donor workup |
| Comparator Agent |
No MRCP |
MRCP is not done along with Liver donor workup |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
All prospective voluntary healthy liver donor of age 18-55 |
|
| ExclusionCriteria |
| Details |
1.Type C/D Portal vein anatomy
2.Left sided Gallbladder
3.Right Posterior Graft
4.Recipients undergoing Hepaticojejunostomy
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare early biliary complications in Liver transplant recipient within first 6 months (Bile Leak, Biliary anastomotic stricture) |
3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Donor biliary complications in both group
|
1 month, 3 months, 6 months |
Identify Risk factors for early Biliary complications in recipients
|
1 month, 3 month, 6 month |
Change of operative plan- Left vs Right Lobe
|
1 month |
| Prevalence of biliary duct variations |
1 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
28/12/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Living donor liver transplantation is widely accepted as an life-saving treatment for patients with end-stage liver diseases. Careful donor selection is essential to maximize the success and minimize the risk of postoperative complications in donors and recipients. Mapping of biliary anatomy is one of the critical assessments for donor selection and surgical planning ,Biliary reconstruction is considered as the “Achilles heel” of liver transplantation and adequate imaging assessment of biliary anatomy can largely benefit the biliary anastomosis. Preoperative imaging assessment of biliary anatomy is good for the selection of donors but may not indispensable for surgical planning and Intraoperative confirmative assessment of biliary anatomy with IOC was essential
|