Liver RegenerationNCT04565535
Effect of Novel Donor Lifestyle Optimisation Protocol on Liver Regeneration in Live Liver Donors
A study testing Novel donor lifestyle optimisation protocol in people with Liver Regeneration, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Steatosis in case of live liver donors is on the rise and around 20- 40 % of prospective liver donors are estimated to have hepatic steatosis. Significant steatosis has been shown to be associated with inferior donor outcomes after liver transplant. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Regeneration
- What is being tested?
- Novel donor lifestyle optimisation protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2020to 30 Apr 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All donors planned for donor hepatectomy and found fit in step II evaluation.
- Those who give consent to be a part of the study.
Who cannot join
- Patients refusing to consent for the study
- Donor of ALF patients.
- Donors undergoing left lateral hepatectomy.
- Donors found unfit after step I/II evaluation.
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
Official title: "Effect of Novel Donor Lifestyle Optimisation Protocol on Liver Regeneration in Live Liver Donors: a Randomised Control Pilot Study"
Steatosis in case of live liver donors is on the rise and around 20- 40 % of prospective liver donors are estimated to have hepatic steatosis. Significant steatosis has been shown to be associated with inferior donor outcomes after liver transplant. Dietary and lifestyle modification has been shown to reduce steatosis and may help improve the donor outcomes after liver transplant. Donors will be randomized between two groups; one will be put under donor lifestyle optimization protocol and the other shall follow normal diet and lifestyle. Donors under optimization protocol would undergo diet modification in the form of healthy, low fat, high protein diet along with exercise for 2 weeks prior to the expected date of surgery. Investigations including liver volumetric assessment, LFT's , lipid profile , Fibroscan shall be done prior to initiation of the diet and then following completion of the 2 weeks of lifestyle modification before surgery. The intraoperative parameters including intraoperative blood loss shall be assessed and a liver biopsy will be taken intraoperatively to assess for steatosis and liver regeneration markers including CK7 and Ki 67 will be assessed. Following surgery, the liver regeneration in donor shall be assessed by doing a liver volumetry by Computed Tomography (CT) at POD7. Post surgery, the donor shall undergo daily LFT's, PT-INR and the time to its normalization and serum bilirubin shall be assessed. Markers of liver regeneration shall also be assessed initially a day before surgery and then at POD 1, 3 and 7.
Read the detailed description
All prospective donors provisionally planned for donor hepatectomy excluding those undergoing left lateral hepatectomy will be informed regarding the current study and informed written consent will be taken from donors willing to participate in the study. After step II evaluation of the donors, they will be randomized into two groups. First group will be put under donor lifestyle optimization protocol and the other shall follow normal diet and lifestyle. Donors under optimization protocol would undergo diet modification in the form of healthy, low fat, high protein diet along with exercise for 2 weeks prior to the expected date of surgery. If the expected date of surgery is delayed because of any cause, the proposed lifestyle optimization shall continue till the date of surgery. Step I of the evaluation including Blood group, coagulation profile, LFT, KFT, Viral serology, Liver attenuation index on Non contrast CT scan of abdomen and a Fibroscan shall be done. After step I investigations are found to be normal, patient would be subjected to step II evaluation consisting of CECT abdomen with liver volumetry including total liver volume, right lobe volume without MHV using ,expected remnant volume using software for analysis of CT volumes, MRCP for biliary anatomy, TFT and lipid profile. Body composition analysis, Fibroscan, lipid profile and LFT shall be done prior to initiation of the diet and then following completion of the 2 weeks of lifestyle modification. The intraoperative parameters including intraoperative blood loss shall be assessed. Intra operative liver biopsy will be taken from segment IV after completion of hepatectomy from all the donors undergoing donor hepatectomy using a core needle biopsy(B Braun® 18g). Precautions will be taken to take adequate tissue samples and avoid subcapsular sampling. Hemostasis of the needle tract will be obtained by use of electro thermal energy source. The core liver biopsy will be sent in formalin containing bottle to the histopathologist. Liver biopsy will be done independently by two expert histopathologists. Any abnormal histopathological finding will be noted, degree of steatosis assessed and regenerative markers from the tissue including CK7 and Ki67 will be assessed. Following surgery, the liver regeneration in donor shall be assessed by doing a liver volumetry at POD7 and POD 14. Following donor hepatectomy, routine parameters like LFT, PT-INR will be documented and the post operative day of normalisation of PT-INR and Serum Bilirubin will be noted. The volumetry of the regenerated liver will be done at day 7 and day 14 in all the donors. Seum level of liver regenerative markers shall(including HGF, IL6, TNF alpha, TGF beta, INF alpha) will be assessed on a day before surgery and then at Post operative day 1, 3 and 7. Liver function tests and PT-INR would be evaluated daily for one week. . In the post operative period , any surgical complication arising will be assessed till first month after surgery and the donor outcomes will be monitored. Complications shall be assessed based on Clavien Dindo Classification.
On follow ups liver function tests will be performed weekly for 1 month and then at monthly intervals till 3 months after surgery. At this time, any long term complication will be assessed.
Study population: Donors undergoing donor hepatectomy after giving informed written consent to be a part of the study.
Study Design: Randomised Control Pilot Study
Study Period: From time of ethical clearance to October 2021.
Sample Size: All the donors planned for donor hepatectomy meeting the inclusion criteria from time of clearance from ethical committee to october 2021 will be enrolled in this study following which randomization will be done on basis of computer generated numbers. Anticipated sample size would be 30 in each group after exclusion.
Inclusion Criteria
All donors planned for donor hepatectomy and found fit in step II evaluation.
Those who give consent to be a part of the study.
Exclusion criteria Patients refusing to consent for the study
Donor of ALF patients.
Donors undergoing left lateral hepatectomy.
Donors found unfit after step I/II evaluation.
Intervention: Diet and lifestyle modification group will receive customized two week diet plan which would consist of calorie restricted(based on basal requirement calculated by Harris Benedict Equation), high protein(25%), low fat(15%) diet along with regular exercise (brisk walk for 45 min/day). Assessment of compliance will be checked by calling each donor twice every week and during their regular weekly follow ups as well.
- Conditions
- Liver Regeneration
- Being tested
- Novel donor lifestyle optimisation protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel donor lifestyle optimisation protocolBehavioural
Diet based on calorie requirement as calculated by indirect calorimetry. Daily exercise.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Liver donors undergoing lifestyle optimisation Receives: Behavioral: Novel donor lifestyle optimisation protocol |
| Control arm | No intervention | Liver donors who continue normal lifestyle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study difference in Liver regeneration in Live Liver Donors on basis of: Post operative day of normalization of serum bilirubin and PT-INR between both the groups.
Serum Bilirubin and PT-INR levels will be measured and their times of normalisation will be taken as markers for regeneration of liver.
Measured: post operative day 1 - day 14
Percentage growth of liver(on basis of CT Volumetry)
liver volumetry will be don eat POst operative day 7 and 14 to assess the percentage growth of liver by doing a CT volumetry.
Measured: post operative day 7 and post operative day 14
Secondary outcomes (5)
To study difference in Steatosis in both groups on basis of intra operative liver biopsy.
Steatosis on basis of intra operative core needle liver biopsy will be seen by the pathologist by histopathological assessment of the core needle biopsy specimen.
Measured: Intra operative.
To study difference in Serum level of markers of liver regeneration after liver transplant in both the groups.
Blood Markers of liver regeneration including Hepatocyte growth factor(HGF), Interleukin 6(IL6), TNF alpha, TGF beta, INF alpha will be assessed.
Measured: Pre op day 14 to post op day 7
To study difference in Rates of early graft dysfunction in recipients in both the groups.
daily liver function tests and Pt-INR will be done in case of recipients and their levels seen to report the number of recipients having early graft dysfunction.
Measured: Day 1-14
To study difference in Body composition analysis and fibroscan before and after lifestyle modification.
Changes in body composition analysis using Bioelectrical impedance analysis and fibroscan will be done.
Measured: at the time of enrollment to pre operative day( 2 weeks).
To study difference in Intraoperative blood loss, post op stay in the hospital and complication rates between both the groups
Difference in intra operative blood loss, post operative stay in the hospital and the complications(as per clavien dindo classification) will be noted.
Measured: post operative day 0 to post operative day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Oct 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viniyendra Pamecha, FEBS, Study director, Institute of Liver & Biliary Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565535
- Sponsor's protocol ID
- ILBS-LIVEDONORS-02
- Status last verified
- May 2023
- First submitted
- 2 Sep 2020
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barth RJ Jr, Mills JB, Suriawinata AA, Putra J, Tosteson TD, Axelrod D, Freeman R, Whalen GF, LaFemina J, Tarczewski SM, Kinlaw WB. Short-term Preoperative Diet Decreases Bleeding After Partial Hepatectomy: Results From a Multi-institutional Randomized Controlled Trial. Ann Surg. 2019 Jan;269(1):48-52. doi: 10.1097/SLA.0000000000002709.
PubMed 29489484Reeves JG, Suriawinata AA, Ng DP, Holubar SD, Mills JB, Barth RJ Jr. Short-term preoperative diet modification reduces steatosis and blood loss in patients undergoing liver resection. Surgery. 2013 Nov;154(5):1031-7. doi: 10.1016/j.surg.2013.04.012. Epub 2013 Jun 27.
PubMed 23809869Cho JY, Suh KS, Lee HW, Cho EH, Yang SH, Cho YB, Yi NJ, Kim MA, Jang JJ, Lee KU. Hepatic steatosis is associated with intrahepatic cholestasis and transient hyperbilirubinemia during regeneration after living donor liver transplantation. Transpl Int. 2006 Oct;19(10):807-13. doi: 10.1111/j.1432-2277.2006.00355.x.
PubMed 16961772Nakamuta M, Morizono S, Soejima Y, Yoshizumi T, Aishima S, Takasugi S, Yoshimitsu K, Enjoji M, Kotoh K, Taketomi A, Uchiyama H, Shimada M, Nawata H, Maehara Y. Short-term intensive treatment for donors with hepatic steatosis in living-donor liver transplantation. Transplantation. 2005 Sep 15;80(5):608-12. doi: 10.1097/01.tp.0000166009.77444.f3.
PubMed 16177634Gupta A, Patil NS, Mohapatra N, Benjamin J, Thapar S, Kumar A, Rastogi A, Pamecha V. Lifestyle Optimization Leads to Superior Liver Regeneration in Live Liver Donors and Decreases Early Allograft Dysfunction in Recipients: A Randomized Control Trial. Ann Surg. 2023 Sep 1;278(3):e430-e439. doi: 10.1097/SLA.0000000000005836. Epub 2023 Mar 13.
PubMed 36912445
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of Novel Donor Lifestyle Optimisation Protocol on Liver Regeneration in Live Liver Donors: a Randomised Control Pilot Study"
- ClinicalTrials.gov ID
- NCT04565535
- Acronym / sponsor ID
- ILBS-LIVEDONORS-02
- Conditions
- Liver Regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 25 Sep 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.
Steatosis in case of live liver donors is on the rise and around 20- 40 % of prospective liver donors are estimated to have hepatic steatosis. Significant steatosis has been shown to be associated with inferior donor outcomes after liver transplant. Dietary and lifestyle modification has been shown to reduce steatosis and may help improve the donor outcomes after liver transplant. Donors will be randomized between two groups; one will be put under donor lifestyle optimization protocol and the other shall follow normal diet and lifestyle. Donors under optimization protocol would undergo diet modification in the form of healthy, low fat, high protein diet along with exercise for 2 weeks prior to the expected date of surgery. Investigations including liver volumetric assessment, LFT's , lipid profile , Fibroscan shall be done prior to initiation of the diet and then following completion of the 2 weeks of lifestyle modification before surgery. The intraoperative parameters including intraoperative blood loss shall be assessed and a liver biopsy will be taken intraoperatively to assess for steatosis and liver regeneration markers including CK7 and Ki 67 will be assessed. Following surgery, the liver regeneration in donor shall be assessed by doing a liver volumetry by Computed Tomography (CT) at POD7. Post surgery, the donor shall undergo daily LFT's, PT-INR and the time to its normalization and serum bilirubin shall be assessed. Markers of liver regeneration shall also be assessed initially a day before surgery and then at POD 1, 3 and 7.
Detailed description
All prospective donors provisionally planned for donor hepatectomy excluding those undergoing left lateral hepatectomy will be informed regarding the current study and informed written consent will be taken from donors willing to participate in the study. After step II evaluation of the donors, they will be randomized into two groups. First group will be put under donor lifestyle optimization protocol and the other shall follow normal diet and lifestyle. Donors under optimization protocol would undergo diet modification in the form of healthy, low fat, high protein diet along with exercise for 2 weeks prior to the expected date of surgery. If the expected date of surgery is delayed because of any cause, the proposed lifestyle optimization shall continue till the date of surgery. Step I of the evaluation including Blood group, coagulation profile, LFT, KFT, Viral serology, Liver attenuation index on Non contrast CT scan of abdomen and a Fibroscan shall be done. After step I investigations are found to be normal, patient would be subjected to step II evaluation consisting of CECT abdomen with liver volumetry including total liver volume, right lobe volume without MHV using ,expected remnant volume using software for analysis of CT volumes, MRCP for biliary anatomy, TFT and lipid profile. Body composition analysis, Fibroscan, lipid profile and LFT shall be done prior to initiation of the diet and then following completion of the 2 weeks of lifestyle modification. The intraoperative parameters including intraoperative blood loss shall be assessed. Intra operative liver biopsy will be taken from segment IV after completion of hepatectomy from all the donors undergoing donor hepatectomy using a core needle biopsy(B Braun® 18g). Precautions will be taken to take adequate tissue samples and avoid subcapsular sampling. Hemostasis of the needle tract will be obtained by use of electro thermal energy source. The core liver biopsy will be sent in formalin containing bottle to the histopathologist. Liver biopsy will be done independently by two expert histopathologists. Any abnormal histopathological finding will be noted, degree of steatosis assessed and regenerative markers from the tissue including CK7 and Ki67 will be assessed. Following surgery, the liver regeneration in donor shall be assessed by doing a liver volumetry at POD7 and POD 14. Following donor hepatectomy, routine parameters like LFT, PT-INR will be documented and the post operative day of normalisation of PT-INR and Serum Bilirubin will be noted. The volumetry of the regenerated liver will be done at day 7 and day 14 in all the donors. Seum level of liver regenerative markers shall(including HGF, IL6, TNF alpha, TGF beta, INF alpha) will be assessed on a day before surgery and then at Post operative day 1, 3 and 7. Liver function tests and PT-INR would be evaluated daily for one week. . In the post operative period , any surgical complication arising will be assessed till first month after surgery and the donor outcomes will be monitored. Complications shall be assessed based on Clavien Dindo Classification.
On follow ups liver function tests will be performed weekly for 1 month and then at monthly intervals till 3 months after surgery. At this time, any long term complication will be assessed.
Study population: Donors undergoing donor hepatectomy after giving informed written consent to be a part of the study.
Study Design: Randomised Control Pilot Study
Study Period: From time of ethical clearance to October 2021.
Sample Size: All the donors planned for donor hepatectomy meeting the inclusion criteria from time of clearance from ethical committee to october 2021 will be enrolled in this study following which randomization will be done on basis of computer generated numbers. Anticipated sample size would be 30 in each group after exclusion.
Inclusion Criteria
All donors planned for donor hepatectomy and found fit in step II evaluation.
Those who give consent to be a part of the study.
Exclusion criteria Patients refusing to consent for the study
Donor of ALF patients.
Donors undergoing left lateral hepatectomy.
Donors found unfit after step I/II evaluation.
Intervention: Diet and lifestyle modification group will receive customized two week diet plan which would consist of calorie restricted(based on basal requirement calculated by Harris Benedict Equation), high protein(25%), low fat(15%) diet along with regular exercise (brisk walk for 45 min/day). Assessment of compliance will be checked by calling each donor twice every week and during their regular weekly follow ups as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Novel donor lifestyle optimisation protocolLiver donors undergoing lifestyle optimisation |
| Control arm | No intervention | –Liver donors who continue normal lifestyle. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All donors planned for donor hepatectomy and found fit in step II evaluation.
- Those who give consent to be a part of the study.
Key exclusion criteria (4 listed)
- Patients refusing to consent for the study
- Donor of ALF patients.
- Donors undergoing left lateral hepatectomy.
- Donors found unfit after step I/II evaluation.
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 |
|---|---|---|
| Novel donor lifestyle optimisation protocolDiet based on calorie requirement as calculated by indirect calorimetry. Daily exercise. | Behavioural | Intervention arm |
Primary outcome
To study difference in Liver regeneration in Live Liver Donors on basis of: Post operative day of normalization of serum bilirubin and PT-INR between both the groups.
Time frame: post operative day 1 - day 14
Serum Bilirubin and PT-INR levels will be measured and their times of normalisation will be taken as markers for regeneration of liver.
Percentage growth of liver(on basis of CT Volumetry)
Time frame: post operative day 7 and post operative day 14
liver volumetry will be don eat POst operative day 7 and 14 to assess the percentage growth of liver by doing a CT volumetry.
5 secondary outcomes
To study difference in Steatosis in both groups on basis of intra operative liver biopsy.
Time frame: Intra operative.
To study difference in Serum level of markers of liver regeneration after liver transplant in both the groups.
Time frame: Pre op day 14 to post op day 7
To study difference in Rates of early graft dysfunction in recipients in both the groups.
Time frame: Day 1-14
To study difference in Body composition analysis and fibroscan before and after lifestyle modification.
Time frame: at the time of enrollment to pre operative day( 2 weeks).
To study difference in Intraoperative blood loss, post op stay in the hospital and complication rates between both the groups
Time frame: post operative day 0 to post operative day 14
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 30 May 2023.
- Background: PubMed 29489484Barth RJ Jr, Mills JB, Suriawinata AA, Putra J, Tosteson TD, Axelrod D, Freeman R, Whalen GF, LaFemina J, Tarczewski SM, Kinlaw WB. Short-term Preoperative Diet Decreases Bleeding After Partial Hepatectomy: Results From a Multi-institutional Randomized Controlled Trial. Ann Surg. 2019 Jan;269(1):48-52. doi: 10.1097/SLA.0000000000002709.
- Background: PubMed 23809869Reeves JG, Suriawinata AA, Ng DP, Holubar SD, Mills JB, Barth RJ Jr. Short-term preoperative diet modification reduces steatosis and blood loss in patients undergoing liver resection. Surgery. 2013 Nov;154(5):1031-7. doi: 10.1016/j.surg.2013.04.012. Epub 2013 Jun 27.
- Background: PubMed 16961772Cho JY, Suh KS, Lee HW, Cho EH, Yang SH, Cho YB, Yi NJ, Kim MA, Jang JJ, Lee KU. Hepatic steatosis is associated with intrahepatic cholestasis and transient hyperbilirubinemia during regeneration after living donor liver transplantation. Transpl Int. 2006 Oct;19(10):807-13. doi: 10.1111/j.1432-2277.2006.00355.x.
- Background: PubMed 16177634Nakamuta M, Morizono S, Soejima Y, Yoshizumi T, Aishima S, Takasugi S, Yoshimitsu K, Enjoji M, Kotoh K, Taketomi A, Uchiyama H, Shimada M, Nawata H, Maehara Y. Short-term intensive treatment for donors with hepatic steatosis in living-donor liver transplantation. Transplantation. 2005 Sep 15;80(5):608-12. doi: 10.1097/01.tp.0000166009.77444.f3.
- Derived from this study: PubMed 36912445Gupta A, Patil NS, Mohapatra N, Benjamin J, Thapar S, Kumar A, Rastogi A, Pamecha V. Lifestyle Optimization Leads to Superior Liver Regeneration in Live Liver Donors and Decreases Early Allograft Dysfunction in Recipients: A Randomized Control Trial. Ann Surg. 2023 Sep 1;278(3):e430-e439. doi: 10.1097/SLA.0000000000005836. Epub 2023 Mar 13.
- 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.
Viniyendra Pamecha, FEBS study director
Institute of Liver & Biliary Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel donor lifestyle optimisation protocol in people with Liver Regeneration, 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 2 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: finished, as of the sponsor's last update on 30 May 2023. 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?
To study difference in Liver regeneration in Live Liver Donors on basis of: Post operative day of normalization of serum bilirubin and PT-INR between both the groups. (time frame: post operative day 1 - day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04565535, which also lists 5 linked publications.
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 30 May 2023.