Effect of Novel Donor Lifestyle Optimisation Protocol on Liver Regeneration in Live Liver Donors

NCT04565535 | Completed

• 1 other identifier: ILBS-LIVEDONORS-02
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liver Regeneration

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• To study difference in Steatosis in both groups on basis of intra operative liver biopsy.

  Intra operative.

• To study difference in Serum level of markers of liver regeneration after liver transplant in both the groups.

  Pre op day 14 to post op day 7

• To study difference in Rates of early graft dysfunction in recipients in both the groups.

  Day 1-14

• To study difference in Body composition analysis and fibroscan before and after lifestyle modification.

  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

  post operative day 0 to post operative day 14

Study Arms (2)

Intervention arm

EXPERIMENTAL

Liver donors undergoing lifestyle optimisation

Behavioral: Novel donor lifestyle optimisation protocol

Control arm

NO INTERVENTION

Liver donors who continue normal lifestyle.

Interventions

Novel donor lifestyle optimisation protocol BEHAVIORAL

Diet based on calorie requirement as calculated by indirect calorimetry. Daily exercise.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All donors planned for donor hepatectomy and found fit in step II evaluation.
• Those who give consent to be a part of the study.

You may not qualify if:

• Patients refusing to consent for the study
• Donor of ALF patients.
• Donors undergoing left lateral hepatectomy.
• Donors found unfit after step I/II evaluation.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (5)

• 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.

  PMID: 29489484 BACKGROUND

• 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.

  PMID: 23809869 BACKGROUND

• 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.

  PMID: 16961772 BACKGROUND

• 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.

  PMID: 16177634 BACKGROUND

• Gupta 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.

  PMID: 36912445 DERIVED

Study Officials

• Viniyendra Pamecha, FEBS

  Institute of Liver & Biliary Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 25, 2020
• Study Start: October 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

IN (1)