Liver Regeneration Clinical Trial
Official title:
"Effect of Novel Donor Lifestyle Optimisation Protocol on Liver Regeneration in Live Liver Donors: a Randomised Control Pilot Study"
Verified date | May 2023 |
Source | Institute of Liver and Biliary Sciences, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | April 30, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
India | Institute of Liver & Biliary Sciences | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Institute of Liver and Biliary Sciences, India |
India,
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. — View Citation
Cho 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. — View Citation
Nakamuta 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. — View Citation
Reeves 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | post operative day 1 - day 14 | |
Primary | 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. | post operative day 7 and post operative day 14 | |
Secondary | 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. | Intra operative. | |
Secondary | 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. | Pre op day 14 to post op day 7 | |
Secondary | 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. | Day 1-14 | |
Secondary | 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. | at the time of enrollment to pre operative day( 2 weeks). | |
Secondary | 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. | post operative day 0 to post operative day 14 |
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