Chronic Liver Disease and CirrhosisNCT07715500
Magnetic Resonance Cholangiopancreatography in Living Liver Donors and Its Relationship With Post Operative Recipient Biliary Complications
A study testing Magnetic Resonance Cholangiopancreatography in people with Chronic Liver Disease and Cirrhosis and Liver Transplant; Complications, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Liver Disease and Cirrhosis, Liver Transplant; Complications, Donor Hepatectomy
- What is being tested?
- Magnetic Resonance Cholangiopancreatography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All prospective voluntary healthy liver donor of age 18-55
Who cannot join
- Type C/D Portal vein anatomy
- Left sided Gallbladder
- Right Posterior Graft
- Recipients undergoing Hepaticojejunostomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr Nilesh Sadashiv Patil, MCH contact
India1 site, 1 recruiting
- Recruiting
ILBS
New Delhi, 110070
Dr Atul Renjit, MBBS, MS, DNB, +91 9632060230, atulrenjit@gmail.com
About this study
Official title: 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
Read the 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
- Being tested
- Magnetic Resonance Cholangiopancreatography
- Keywords
- Liver Transplantation, Magnetic Resonance Cholangiopancreatography, Liver donors
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance CholangiopancreatographyDiagnostic test
Magnetic Resonance Cholangiopancreatography is being excluded from list of Investigation as part of Non inferiority trial
| Study group | Role | What they receive |
|---|---|---|
| No MRCP GROUP | No intervention | Magnetic Resonance Cholangiopancreatography is not done as part of Routine Liver donor workup |
| MRCP GROUP | Experimental | Magnetic Resonance Cholangiopancreatography is done as part of Routine Liver donor workup Receives: Diagnostic Test: Magnetic Resonance Cholangiopancreatography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month of postop
Secondary outcomes (2)
Donor biliary complications in both group
Bile leak or strictures in Liver Donors
Measured: 1 month of postoperative period
Identify Risk factors for early Biliary complications in recipients
Identify Risk factors for early Biliary complications in recipients
Measured: till 6 months of Post operative period of Liver transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Jul 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver Disease and CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715500
- Sponsor's protocol ID
- IEC/2025/119/MA04
- Status last verified
- Jan 2026
- First submitted
- 1 Jan 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Cholangiopancreatography in Living Liver Donors and Its Relationship With Post Operative Recipient Biliary Complications - Open Label Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07715500
- Acronym / sponsor ID
- IEC/2025/119/MA04
- Keywords
- Liver Transplantation, Magnetic Resonance Cholangiopancreatography, Liver donors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No MRCP GROUP | No intervention | –Magnetic Resonance Cholangiopancreatography is not done as part of Routine Liver donor workup |
| MRCP GROUP | Experimental | Diagnostic Test: Magnetic Resonance CholangiopancreatographyMagnetic Resonance Cholangiopancreatography is done as part of Routine Liver donor workup |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All prospective voluntary healthy liver donor of age 18-55
Key exclusion criteria (4 listed)
- Type C/D Portal vein anatomy
- Left sided Gallbladder
- Right Posterior Graft
- Recipients undergoing Hepaticojejunostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance CholangiopancreatographyMagnetic Resonance Cholangiopancreatography is being excluded from list of Investigation as part of Non inferiority trial | Diagnostic test | MRCP GROUP |
Primary outcome
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
Time frame: 6 month of postop
2 secondary outcomes
Donor biliary complications in both group
Time frame: 1 month of postoperative period
Identify Risk factors for early Biliary complications in recipients
Time frame: till 6 months of Post operative period of Liver transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Nilesh Sadashiv Patil, MCH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Cholangiopancreatography in people with Chronic Liver Disease and Cirrhosis and Liver Transplant; Complications, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Atul Renjit, MBBS, MS, DNB (+91 9632060230, atulrenjit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 month of postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.