Abstract:Abstract: Objective To evaluate the feasibility and safety of self-made optical balloon dilator for percutaneous nephrolithotomy (PCNL) in treatment of renal calculi. Methods There were 20 patients underwent PCNL with self-made device for the tract establishment from March 2017 to March 2018, 12 cases of male and 8 cases of female. The mean±SD (range) patients’ age was 26 ~ 73 (47.8 ± 12.7) years, stone volume was 2.0 ~ 3.5 (2.5 ± 0.4) cm and stone density was 579 ~ 1247 (978.7 ± 221.6) HU. The factors analysed were demographic variables including age, sex, stone volume, stone density (HU) and stone location, and intra-and peri-operative variables such as operating time, drop in haemoglobin level, stone clearance and complications. Results All tracts were successfully developed with the optical nephrostomy balloon dilator. Tract development time was 5.0 ~ 13.5 (7.2 ± 2.1) min, and operation time was 30 ~ 120 (59.1 ± 21.9) min. Two patients who suffered hematuria (Clavien I) underwent conservative treatment and recovered well. Hemoglobin decrease was 3.4 ~ 10.4 (5.5 ± 1.8) g/L, and hospital time was 4 ~ 7 (5.1 ± 0.9) d. No patient required blood transfusion. There were no major complications, the respective stone free and success rate at the first month after operation was 90.00% (18/20) and 95.00%(19/20), and at the third month after operation was both 100.00%. One patient underwent ESWL and the fragments was discharged at 3 months follow up. Conclusion Optical balloon facilitate accurately developing tract and improving surgery success rate.