Liver RegenerationNCT06091787
Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration on Right Lobe Donor Hepatectomy
A study testing Ursodeoxycholic acid and Standard Medical Treatment in people with Liver Regeneration and Ursodeoxycholic Acid, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The goal of this open label randomized trial is to understand the role of oral ursodeoxycholic acid(UDCA) supplementation in the liver regeneration (in terms of liver function and anatomical growth) following right lobe donor hepatectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Regeneration, Ursodeoxycholic Acid, Partial Liver Resection
- What is being tested?
- Ursodeoxycholic acid and Standard Medical Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All live donors undergoing Right Donor Hepatectomy in ILBS from ethical board clearance to December 2024 in the Department of HPB Surgery and Liver Transplantation, Institute of Liver and Biliary Sciences, New Delhi
Who cannot join
- Negative consent
- Hypersensitivity to UDCA
- Past history of UDCA use in the last two weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration on Right Lobe Donor Hepatectomy: An Open Label Randomised Trial
The goal of this open label randomized trial is to understand the role of oral ursodeoxycholic acid(UDCA) supplementation in the liver regeneration (in terms of liver function and anatomical growth) following right lobe donor hepatectomy. The main question it aims to answer are:
- Does Ursodeoxycholic acid supplementation on patients undergoing donor hepatectomy improve anatomical liver regeneration after partial hepatectomy as compared to control group.
- Does ursodeoxycholic acid improve liver regeneration in terms of liver function tests and biomarkers of liver regeneration(HGF, IL6, TNF Alpha, AFP, TGF Beta) as compared to control group.
Read the detailed description
This open label randomized control study aims to analyze the effect of ursodeoxycholic acid supplementation on liver regeneration following a right donor hepatectomy. All eligible live donors who undergo right donor hepatectomy during the study period will be included in the study and randomized into two groups. One group will receive Tab. UDCA 450mg twice daily for 10 days and the other group will not receive Tab UDCA. Live donors who are not willing to participate in the study, have hypersensitivity to UDCA or have used Tab UDCA in the past 2 weeks, will be excluded from the study. All live donors will be screened in the pre-operative period in the outpatient department.
Pre- operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system(PACS). The enrolled subjects will be followed up till for a period of 14 days after the donor hepatectomy till Non contrast CT Abdomen is done and regenerated liver volumes are analyzed. The anatomic(volumetric), functional(liver function tests) and regenerative biomarkers( HGF, TNF-Alpha, IL6, AFP, TGF-Beta) will be compared between the two groups.
- Being tested
- Ursodeoxycholic acid, Standard Medical Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic acidDrug
Tablet Ursodeoxycholic acid 450mg per orally twice daily from Post operative day 1 to post operative day 10.
Standard Medical TreatmentOther
Standard Medical Treatment
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | This group will recieve Tab Ursodeoxycholic acid 450mg twice daily from the day after donor hepatectomy till post operative day 10. Receives: Drug: Ursodeoxycholic acid |
| Control Arm | Active comparator | This group will receive standard medical therapy following donor hepatectomy. Receives: Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regenerated liver volume on Post-operative Day 14 between two groups.
- This will be measured by a non contrast CT Abdomen and the size of the regenerated liver after hepatectomy will be measured in millilitres
- This value will be measured in both groups to identify a difference in the intervention group (getting UDCA) versus the control group ( standard medical therapy)
Measured: 14 days after operation
Regenerated liver volume on Post-operative Day 7 between two groups.
- This will be measured by a non contrast CT Abdomen and the size of the regenerated liver after hepatectomy will be measured in millilitres
- This value will be measured in both groups to identify a difference in the intervention group (getting UDCA) versus the control group ( standard medical therapy)
Measured: 7 days after operation
Percentage of Total Liver Volume Restored on Post-operative Day 7 between two groups.
The percentage of Total liver volume restored on Post operative day 7 compared to the pre-operative total liver volume, between two groups.
Measured: 7 days after operation
Percentage of Liver Volume restored on Post-operative Day 14 between two groups.
Percentage of liver volume restored on on Post operative day 14, compared to pre-operative total liver volume, between two groups.
Measured: 14 days after the operation
Absolute Liver Volume growth on Day 7
Pre-operative remnant liver volume subtracted from regenerated liver volume on Post-operative day 7, between both groups.
Measured: 7 days after the operation
Absolute Liver volume growth on day 14
Pre-operative remnant liver volume subtracted from regenerated liver volume on Post-operative day 14, between both groups.
Measured: 14 days after the operation
Regeneration Velocity on Post operative day 14, between both groups
Rate of regeneration of liver(g/day), denoted by subtracting pre-operative remnant liver volume from regenerated liver volume on post operative day 14, divided by 14.
Measured: 14 days after the operation
Secondary outcomes (17)
Total bilirubin
serum total bilirubin versus control group
Measured: Post-operative day 1-7, 10 and 14
Direct bilirubin
serum Direct bilirubin versus control group
Measured: Post-operative day 1-7, 10 and 14
Alanine Aminotransferase(ALT)
serum ALT versus control group
Measured: Post-operative day 1-7, 10 and 14
Aspartate Aminotransferase(AST)
serum AST versus control group
Measured: Post-operative day 1-7, 10 and 14
Serum Alkaline Phosphatase(SAP)
serum SAP versus control group
Measured: Post-operative day 1-7, 10 and 14
Serum Gamma Glutamyl Transferase(GGT)
serum SAP versus control group
Measured: Post-operative day 1-7, 10 and 14
Serum Albumin
serum Albumin versus control group
Measured: Post-operative day 1-7, 10 and 14
International normalized ratio(INR)
INR versus control group
Measured: Post-operative day 1-7, 10 and 14
Post hepatectomy liver failure(PHLF)
Grade of PHLF as per ISGLS criteria and 50/50 criteria
Measured: Post operative day 1-14
Abdominal Drain removal
Day of abdominal drain removal
Measured: Post operative day 1-14
Post-operative ascites
Volume of ascites
Measured: Post operative day 1-14
Post-operative complications
Grade of post-operative complications as per Clavien-Dindo classification
Measured: Post operative day 1-14
Markers of liver regeneration - Serum TNF Alpha
Serum TNF Alpha vs in Control group
Measured: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day7
Markers of liver regeneration - Serum IL6
Serum IL6 vs in Control group
Measured: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
Markers of liver regeneration - Serum Alpha Fetoprotein
Serum Alpha Fetoprotein vs in Control group
Measured: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
Markers of liver regeneration - TGF Beta
TGF Beta vs in Control group
Measured: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
Markers of liver regeneration - Hepatocyte growth factor in blood
Hepatocyte growth factor vs in Control group
Measured: Pre-op Baseline , Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Sep 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver RegenerationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomised controlled trial with 2 groups. One group receiving Tablet Ursodeoxycholic acid and the other group not receiving standard medical therapy
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nihar Rn Mohapatra, MBBS,MS, MCh, Study chair, Institute of Liver and Biliary Sciences, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091787
- Sponsor's protocol ID
- IEC/2023/104/MA01
- Status last verified
- Dec 2025
- First submitted
- 5 Oct 2023
- Last updated
- 24 Dec 2025
- 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration on Right Lobe Donor Hepatectomy: An Open Label Randomised Trial
- ClinicalTrials.gov ID
- NCT06091787
- Acronym / sponsor ID
- IEC/2023/104/MA01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 19 Oct 2023 (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.
The goal of this open label randomized trial is to understand the role of oral ursodeoxycholic acid(UDCA) supplementation in the liver regeneration (in terms of liver function and anatomical growth) following right lobe donor hepatectomy. The main question it aims to answer are:
- Does Ursodeoxycholic acid supplementation on patients undergoing donor hepatectomy improve anatomical liver regeneration after partial hepatectomy as compared to control group.
- Does ursodeoxycholic acid improve liver regeneration in terms of liver function tests and biomarkers of liver regeneration(HGF, IL6, TNF Alpha, AFP, TGF Beta) as compared to control group.
Detailed description
This open label randomized control study aims to analyze the effect of ursodeoxycholic acid supplementation on liver regeneration following a right donor hepatectomy. All eligible live donors who undergo right donor hepatectomy during the study period will be included in the study and randomized into two groups. One group will receive Tab. UDCA 450mg twice daily for 10 days and the other group will not receive Tab UDCA. Live donors who are not willing to participate in the study, have hypersensitivity to UDCA or have used Tab UDCA in the past 2 weeks, will be excluded from the study. All live donors will be screened in the pre-operative period in the outpatient department.
Pre- operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system(PACS). The enrolled subjects will be followed up till for a period of 14 days after the donor hepatectomy till Non contrast CT Abdomen is done and regenerated liver volumes are analyzed. The anatomic(volumetric), functional(liver function tests) and regenerative biomarkers( HGF, TNF-Alpha, IL6, AFP, TGF-Beta) will be compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomised controlled trial with 2 groups. One group receiving Tablet Ursodeoxycholic acid and the other group not receiving standard medical therapy
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Drug: Ursodeoxycholic acidThis group will recieve Tab Ursodeoxycholic acid 450mg twice daily from the day after donor hepatectomy till post operative day 10. |
| Control Arm | Active comparator | Other: Standard Medical TreatmentThis group will receive standard medical therapy following donor hepatectomy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All live donors undergoing Right Donor Hepatectomy in ILBS from ethical board clearance to December 2024 in the Department of HPB Surgery and Liver Transplantation, Institute of Liver and Biliary Sciences, New Delhi
Key exclusion criteria (3 listed)
- Negative consent
- Hypersensitivity to UDCA
- Past history of UDCA use in the last two weeks
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 |
|---|---|---|
| Ursodeoxycholic acidTablet Ursodeoxycholic acid 450mg per orally twice daily from Post operative day 1 to post operative day 10. | Drug | Study Arm |
| Standard Medical TreatmentStandard Medical Treatment | Other | Control Arm |
Primary outcome
Regenerated liver volume on Post-operative Day 14 between two groups.
Time frame: 14 days after operation
* This will be measured by a non contrast CT Abdomen and the size of the regenerated liver after hepatectomy will be measured in millilitres * This value will be measured in both groups to identify a difference in the intervention group (getting UDCA) versus the control group ( standard medical therapy)
Regenerated liver volume on Post-operative Day 7 between two groups.
Time frame: 7 days after operation
* This will be measured by a non contrast CT Abdomen and the size of the regenerated liver after hepatectomy will be measured in millilitres * This value will be measured in both groups to identify a difference in the intervention group (getting UDCA) versus the control group ( standard medical therapy)
Percentage of Total Liver Volume Restored on Post-operative Day 7 between two groups.
Time frame: 7 days after operation
The percentage of Total liver volume restored on Post operative day 7 compared to the pre-operative total liver volume, between two groups.
Percentage of Liver Volume restored on Post-operative Day 14 between two groups.
Time frame: 14 days after the operation
Percentage of liver volume restored on on Post operative day 14, compared to pre-operative total liver volume, between two groups.
Absolute Liver Volume growth on Day 7
Time frame: 7 days after the operation
Pre-operative remnant liver volume subtracted from regenerated liver volume on Post-operative day 7, between both groups.
Absolute Liver volume growth on day 14
Time frame: 14 days after the operation
Pre-operative remnant liver volume subtracted from regenerated liver volume on Post-operative day 14, between both groups.
Regeneration Velocity on Post operative day 14, between both groups
Time frame: 14 days after the operation
Rate of regeneration of liver(g/day), denoted by subtracting pre-operative remnant liver volume from regenerated liver volume on post operative day 14, divided by 14.
17 secondary outcomes
Total bilirubin
Time frame: Post-operative day 1-7, 10 and 14
Direct bilirubin
Time frame: Post-operative day 1-7, 10 and 14
Alanine Aminotransferase(ALT)
Time frame: Post-operative day 1-7, 10 and 14
Aspartate Aminotransferase(AST)
Time frame: Post-operative day 1-7, 10 and 14
Serum Alkaline Phosphatase(SAP)
Time frame: Post-operative day 1-7, 10 and 14
Serum Gamma Glutamyl Transferase(GGT)
Time frame: Post-operative day 1-7, 10 and 14
Serum Albumin
Time frame: Post-operative day 1-7, 10 and 14
International normalized ratio(INR)
Time frame: Post-operative day 1-7, 10 and 14
Post hepatectomy liver failure(PHLF)
Time frame: Post operative day 1-14
Abdominal Drain removal
Time frame: Post operative day 1-14
Post-operative ascites
Time frame: Post operative day 1-14
Post-operative complications
Time frame: Post operative day 1-14
Markers of liver regeneration - Serum TNF Alpha
Time frame: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day7
Markers of liver regeneration - Serum IL6
Time frame: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
Markers of liver regeneration - Serum Alpha Fetoprotein
Time frame: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
Markers of liver regeneration - TGF Beta
Time frame: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
Markers of liver regeneration - Hepatocyte growth factor in blood
Time frame: Pre-op Baseline , Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- 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. This study is not recruiting at the moment.
Nihar Rn Mohapatra, MBBS,MS, MCh study chair
Institute of Liver and Biliary Sciences, New Delhi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ursodeoxycholic acid and Standard Medical Treatment in people with Liver Regeneration and Ursodeoxycholic Acid, 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 3 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: finished, as of the sponsor's last update on 24 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regenerated liver volume on Post-operative Day 14 between two groups. (time frame: 14 days after operation). The study lists 7 primary outcomes in all. 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 24 Dec 2025.