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

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.