NCT04565535 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
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.
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.

"Effect of Novel Donor Lifestyle Optimisation Protocol on Liver Regeneration in Live Liver Donors: a Randomised Control Pilot Study"

Clinical trial NCT04565535 - References