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Objective: To assess the first experience of 3D imaging for laparoscopic donor nephrectomy., Material and Methods: The study included 28 laparoscopic donor nephrectomies and 28 subsequent transplantations to related recipients. Of these, 14 laparoscopic donor nephrectomies were performed using 3D camera. The main intraoperative parameters and information about postoperative period in donors and recipients were compared with similar data on previous laparoscopic donor nephrectomies and kidney transplantations with traditional 2D imaging. There were 15 left-sided and 13 right-sided nephrectomies. Twenty and eight laparoscopic nephrectomies were performed via retroperitoneal and transperitoneal access, respectively. There were no significant between-group differences in age, sex ratio, BMI, side of surgery and number of renal arteries., Results: Surgery time (119.28±9.18 and 124.85±7.49 min, respectively) and blood loss (106.78±16.12 and 119.28±19.79 ml, respectively) were similar. Laparoscopic nephrectomy with 3D imaging was followed by significantly shorter primary warm ischemia (2.41±0.79 and 3.23±0.57 min, respectively, p =0.004) and time of extracorporeal preparation of the transplant (back table) under cold preservation (27.21±5.42 and 32.36±5.33 min, respectively, p =0.02)., Conclusion: Initial experience of video systems with 3D imaging in laparoscopic donor nephrectomy has not yet led to significant reduction of surgery time and improvement of transplant function compared to traditional 2D imaging. At the same time, there was a shorter period of primary warm ischemia and back table time. Further analysis is needed to assess possible benefits of 3D imaging in laparoscopic donor nephrectomy.

Background: EPREX®/ERYPO®/PROCRIT® (epoetin alfa, Janssen-Cilag GmbH) was the first available recombinant human erythropoietin (rHuEPO) and was universally reference product as per the recommendation provided by European Medicines Agency. EPIAO® is a biosimilar formulation of EPREX®, and making it a 1:1 dose conversion from EPREX® according to recommendation of European Medicines Agency. This study evaluated the clinical efficacy and safety of EPIAO® in subjects with end-stage renal disease receiving hemodialysis after intravenous administration., Methods: This study was a multicenter, prospective, randomized, double-blind, parallel-group, 2-cohort, maintenance phase, therapeutic equivalence study to evaluate a 1:1 dose conversion from EPREX® to EPIAO® in terms of clinical efficacy and safety that was conducted at 20 sites in 2 countries in patients with end-stage renal disease on hemodialysis. Eligible subjects were treated with EPREX® (reference product of epoetin) for a period of at least 3 months before the treatment period, and then were randomly assigned to the group of EPREX® or EPIAO®. Primary endpoints were mean absolute change in hemoglobin level and mean absolute change in weekly epoetin dosage from baseline to 6 months after treatment with EPIAO®/EPREX® in parallel groups., Results: A total of 200 people received the random intervention and were included in the safety set. After 6, 9, and 12 months of treatment with EPIAO® or EPREX®, there were no significant differences in the hemoglobin levels of the 2 groups compared with baseline. The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ±0.5 g/dL. There were no significant differences in the epoetin dosage of the 2 groups compared with the baseline. The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ± 45 IU/kg. There were no significant differences in the incidence of adverse events between the EPIAO® and EPREX® groups. Most adverse events were mild to moderate and were reverted/resolved., Conclusion: EPIAO® demonstrated promising effectiveness and manageable safety in patients with end-stage renal disease on hemodialysis., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)