Non Alcoholic SteatohepatitisNCT04571957
Expanding Donor Pool for Live Donor Liver Transplantation: Utilization of Donors With NASH After Optimization
An observational study of Non Alcoholic Steatohepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Live donor liver transplantation (LDLT) is the treatment of choice for end-stage liver disease, predominantly in the East, where deceased donor liver transplantation is sparse. In LDLT, donor selection has to be stringent; as the donor safety is thepriority. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Non Alcoholic Steatohepatitis
- How many people
- 410 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2018to 30 Jun 2019
- Phase
- Observational
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients underwent LDLT from June 2011 to January 2019 at Institute of Liver \& Biliary Sciences, New Delhi
Who may be able to join
- Live Liver Donors who had undergone major hepatectomy (removal of ≥ 3 liver segments)
Who cannot join
- Live Liver Donors who had undergone minor hepatectomy (removal of < 3 liver segments)
- Live Liver Donors of recipients with acute liver failure.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Live donor liver transplantation (LDLT) is the treatment of choice for end-stage liver disease, predominantly in the East, where deceased donor liver transplantation is sparse. In LDLT, donor selection has to be stringent; as the donor safety is thepriority. Live liver donors (LLD) with complex biliary and vascular anatomy are increasingly being accepted for donation with the betterment of technical expertise. One of the commonest reasons for LLD rejection is the hepatic parenchymal abnormality because ofsteatosis and steatohepatitis, which can increase the donor risk. Retrospective analysis of donors with non-alcoholic steatohepatitis(NASH) who were optimized and taken up for major hepatectomy from June 2011 to January 2018will be performed.
Read the detailed description
Study Design Aim and Objective -
- Primary objective:
- To study the effect of donor optimization protocol in donors with biopsy proven NASH
- To study thebiochemical (LFTSs \& INR) recovery in donors with NASH after major hepatectomy
- To compare their biochemical recovery parameters (LFTs \& INR) with that of non NASH donors.
- Secondary objectives:
- To study incidence of NASH among live liver donors
- To study their respective recipients' outcomes
- To study the morbidity among LLDs with NASH after major hepatectomy
Methodology:
- Study population:Patients underwentLDLT from June 2011 to January 2019 at Institute of Liver \& Biliary Sciences, New Delhi
- Study design:Retrospective study
- Study period:from June 2011 to January 2019
- Sample size with justification:All consecutive LLDs with at least one year of follow up post-operatively
- Intervention: none
- Monitoring and assessment:none Statistical Analysis:Categorical variables were presented as number (percentage) and were compared using the Chi-square test. Continuous variables were presented as mean (standard deviation, SD) and were compared using Mann-Whitney U Test.
Adverse Effects: None Stopping Rule of Study: None
Expected Outcome of the Project: Adherence to a strict dietary and lifestyle modifications plan will cause histological reversal of NASH and fibrosis in LLDs. Their clinical and biochemical recovery following the major hepatectomy will be similar to that of non-NASH LLDs.
- Conditions
- Non Alcoholic Steatohepatitis
- Being tested
- No Intervention
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Donors with NASH | Donors with NASH underwent donor optimization protocol Receives: Other: No Intervention | |
| Donors without NASH | Donors without NASH Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of donor optimization protocol on body weight in donors with biopsy proven NASH
Measured: 6 weeks to 3 months
Effect of donor optimization protocol on liver attenuation index in donor with biopsy proven NASH.
Measured: 6 weeks to 3 months
Effect of donor optimization protocol on lipid profile in donors with biopsy proven NASH.
Measured: 6 weeks to 3 months
Effect of donor optimization protocol on Liver Function Test in donors with biopsy proven NASH.
Measured: 6 weeks to 3 months
Improvement in Liver Function Test in donors with NASH after major hepatectomy.
Measured: Day 0 to Day 7
Improvement in Coagulation Profile in donors with NASH after major hepatectomy.
Measured: Day 0 to Day 7
Improvement in Liver Function Test between both the groups
Measured: Day 0 to Day 7
Secondary outcomes (3)
Proportion of NASH among live liver donors
Measured: Day 0
Morbidity among Live Liver Donors with NASH after major hepatectomy
Measured: Day 0 to Day 30
Post Operative complications of recipients in both the groups
Measured: Day 0 to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Dec 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcoholic SteatohepatitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 410 participants (actual)
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
- NCT04571957
- Sponsor's protocol ID
- ILBS-LIVEDONORS-03
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Donor Pool for Live Donor Liver Transplantation: Utilization of Donors With NASH After Optimization
- ClinicalTrials.gov ID
- NCT04571957
- Acronym / sponsor ID
- ILBS-LIVEDONORS-03
- Conditions
- Non Alcoholic Steatohepatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 1 Oct 2020 (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.
Live donor liver transplantation (LDLT) is the treatment of choice for end-stage liver disease, predominantly in the East, where deceased donor liver transplantation is sparse. In LDLT, donor selection has to be stringent; as the donor safety is thepriority. Live liver donors (LLD) with complex biliary and vascular anatomy are increasingly being accepted for donation with the betterment of technical expertise. One of the commonest reasons for LLD rejection is the hepatic parenchymal abnormality because ofsteatosis and steatohepatitis, which can increase the donor risk. Retrospective analysis of donors with non-alcoholic steatohepatitis(NASH) who were optimized and taken up for major hepatectomy from June 2011 to January 2018will be performed.
Detailed description
Study Design Aim and Objective -
- Primary objective:
- To study the effect of donor optimization protocol in donors with biopsy proven NASH
- To study thebiochemical (LFTSs \& INR) recovery in donors with NASH after major hepatectomy
- To compare their biochemical recovery parameters (LFTs \& INR) with that of non NASH donors.
- Secondary objectives:
- To study incidence of NASH among live liver donors
- To study their respective recipients' outcomes
- To study the morbidity among LLDs with NASH after major hepatectomy
Methodology:
- Study population:Patients underwentLDLT from June 2011 to January 2019 at Institute of Liver \& Biliary Sciences, New Delhi
- Study design:Retrospective study
- Study period:from June 2011 to January 2019
- Sample size with justification:All consecutive LLDs with at least one year of follow up post-operatively
- Intervention: none
- Monitoring and assessment:none Statistical Analysis:Categorical variables were presented as number (percentage) and were compared using the Chi-square test. Continuous variables were presented as mean (standard deviation, SD) and were compared using Mann-Whitney U Test.
Adverse Effects: None Stopping Rule of Study: None
Expected Outcome of the Project: Adherence to a strict dietary and lifestyle modifications plan will cause histological reversal of NASH and fibrosis in LLDs. Their clinical and biochemical recovery following the major hepatectomy will be similar to that of non-NASH LLDs.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donors with NASH | – | Other: No InterventionDonors with NASH underwent donor optimization protocol |
| Donors without NASH | – | Other: No InterventionDonors without NASH |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients underwent LDLT from June 2011 to January 2019 at Institute of Liver \& Biliary Sciences, New Delhi
Key inclusion criteria (1 listed)
- Live Liver Donors who had undergone major hepatectomy (removal of ≥ 3 liver segments)
Key exclusion criteria (2 listed)
- Live Liver Donors who had undergone minor hepatectomy (removal of < 3 liver segments)
- Live Liver Donors of recipients with acute liver failure.
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 |
|---|---|---|
| No InterventionNo Intervention | Other | Donors with NASH, Donors without NASH |
Primary outcome
Effect of donor optimization protocol on body weight in donors with biopsy proven NASH
Time frame: 6 weeks to 3 months
Effect of donor optimization protocol on liver attenuation index in donor with biopsy proven NASH.
Time frame: 6 weeks to 3 months
Effect of donor optimization protocol on lipid profile in donors with biopsy proven NASH.
Time frame: 6 weeks to 3 months
Effect of donor optimization protocol on Liver Function Test in donors with biopsy proven NASH.
Time frame: 6 weeks to 3 months
Improvement in Liver Function Test in donors with NASH after major hepatectomy.
Time frame: Day 0 to Day 7
Improvement in Coagulation Profile in donors with NASH after major hepatectomy.
Time frame: Day 0 to Day 7
Improvement in Liver Function Test between both the groups
Time frame: Day 0 to Day 7
3 secondary outcomes
Proportion of NASH among live liver donors
Time frame: Day 0
Morbidity among Live Liver Donors with NASH after major hepatectomy
Time frame: Day 0 to Day 30
Post Operative complications of recipients in both the groups
Time frame: Day 0 to day 30
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 1 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Alcoholic Steatohepatitis, 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 2 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 1 Oct 2020. 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?
Effect of donor optimization protocol on body weight in donors with biopsy proven NASH (time frame: 6 weeks to 3 months). 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 1 Oct 2020; AzTrials last refreshed its copy on 6 Nov 2026.