A Randomized, Single-Blind Clinical Trial Comparing Robotic-Assisted Fluoroscopic-Guided with Ultrasound-Guided Renal Access for Percutaneous Nephrolithotomy

Abstract

Purpose: We conducted a randomized, single-blind clinical trial comparing the surgical outcomes of robotic-assisted fluoroscopic-guided (RAF group) and ultrasound-guided (US group) renal access in mini-percutaneous nephrolithotomy (PCNL). Materials and Methods: We recruited patients who underwent mini-PCNL with ureteroscopic assistance for large renal stones between January 2020 and May 2021. Block randomization was performed using online software. Automated needle target with x-ray was used for fluoroscopic-guided renal access in the RAF group. PCNL was performed by residents using a pneumatic lithotripsy system with 16.5Fr/17.5Fr tracts. The primary outcome was single puncture success, and the secondary outcomes were stone-free rate, complication rate, parameters measured during renal access and fluoroscopy time. Results: In total, 71 patients (35 in US group, 36 in RAF group) were enrolled. No difference was seen in the single puncture success rate between the US and RAF groups (34.3% and 50.0%, p[0.2). In 14.3% cases in the US group vs no cases in the RAF group, the resident was unable to obtain access due to difficult targeting (p[0.025). The mean number of needle punctures was significantly fewer, and the median duration of needle puncture was shorter in the RAF group (1.83 vs 2.51 times, p[0.025; 5.5 vs 8.0 minutes, p[0.049, respectively). The stone-free rate at 3 months after surgery was 83.3% and 70.6% in the RAF and US

Advances in percutaneous renal puncture: a comprehensive review of the literature

“…On the contrary, RAF proved to be associated with a lower number of needle punctures (1.83 vs. 2.51, P = 0.025) and shorter mean puncture duration (5.50 vs. 8.00 min, P = 0.049). It is also remarkable that the urology residents achieved access in all the cases using this new technology [33 ▪▪ ].…”

“…In 2022, Taguchi et al . [33 ▪▪ ] presented the ANT-X (automated needle targeting with X-ray) system, a robotic arm that, after being mounted on the patient's back and after the needle being marked on the region of skin above the calyx target, is capable to perform on his own the bull's-eye technique. The surgeon has only to confirm the depth under fluoroscopy.…”

The technological future of percutaneous nephrolithotomy: a Young Academic Urologists Endourology and Urolithiasis Working Group update

“…Recently in the first human trial, this system was successful in obtaining PCA in first attempt [13]. The first randomized trial conducted by Taguchi et al [14] compared the surgical outcomes of ultrasound-guided (US) vs. robotic assisted (RAF) PCA in mPCNL. There was no statistically significant difference in terms of successful PCA in first attempt (34.3% vs. 50.0%, P = 0.2).…”

Percutaneous management of upper tract stones: from mini to maxi percutaneous nephrolithotomy

“…As with other areas of urology, robotics continues to be at the forefront of technological advances. Taguchi et al [30 ▪ ] performed a randomized controlled trial assessing robotic-assisted fluoroscopic-guided renal access to ultrasound-guided access by novice urologists. In total, 71 patients were randomized to either group, with the ANT-X robotic platform (NDR Medical Technology, Singapore) used in the robotic-assisted group.…”