Magnetic Resonance Cholangiopancreatography in Living Liver Donors and Its Relationship With Post Operative Recipient Biliary Complications

Magnetic Resonance Cholangiopancreatography in Living Liver Donors and Its Relationship With Post Operative Recipient Biliary Complications - Open Label Randomised Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Liver Transplant; Complications; Chronic Liver Disease and Cirrhosis; Donor Hepatectomy
• Intervention / Treatment: Diagnostic test: Magnetic Resonance Cholangiopancreatography

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Atul Renjit, MBBS, MS, DNB; Phone Number: +91 9632060230; Email: atulrenjit@gmail.com
• Study Contact Backup: Name: Dr Nilesh Sadashiv Patil, MCH

Study Locations

• India
  • New Delhi, India, 110070
    • Recruiting
    • ILBS
    • Contact: Dr Atul Renjit, MBBS, MS, DNB; Phone Number: +91 9632060230; Email: atulrenjit@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All prospective voluntary healthy liver donor of age 18-55

Exclusion Criteria:

• Type C/D Portal vein anatomy
• Left sided Gallbladder
• Right Posterior Graft
• Recipients undergoing Hepaticojejunostomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No MRCP GROUP; Magnetic Resonance Cholangiopancreatography is not done as part of Routine Liver donor workup
Experimental: MRCP GROUP; Magnetic Resonance Cholangiopancreatography is done as part of Routine Liver donor workup	Diagnostic test: Magnetic Resonance Cholangiopancreatography; Magnetic Resonance Cholangiopancreatography is being excluded from list of Investigation as part of Non inferiority trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To identify factors causing early biliary complications like type and number of arterial & biliary reconstruction, type of graft, number & size of Bile ducts in donor in both groups	6 month of postop

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Donor biliary complications in both group	Bile leak or strictures in Liver Donors	1 month of postoperative period
Identify Risk factors for early Biliary complications in recipients	Identify Risk factors for early Biliary complications in recipients	till 6 months of Post operative period of Liver transplant

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: January 1, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Liver Transplantation; Liver donors; Magnetic Resonance Cholangiopancreatography
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Tomography; Diagnostic Imaging; Magnetic Resonance Imaging; Cholangiopancreatography, Magnetic Resonance
• Other Study ID Numbers: IEC/2025/119/MA04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No