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JU INSIGHT A Randomized, Single-Blind Clinical Trial Comparing Robotic-Assisted Fluoroscopic-Guided with Ultrasound- Guided Renal Access for Percutaneous Nephrolithotomy
By: Kazumi Taguchi, MD, PhD; Shuzo Hamamoto, MD, PhD; Atsushi Okada, MD, PhD; Teruaki Sugino, MD, PhD; Rei Unno, MD, PhD; Taiki Kato, MD, PhD; Hidekatsu Fukuta, MD, PhD; Ryosuke Ando, MD, PhD; Noriyasu Kawai, MD, PhD; Yung Khan Tan, MD; Takahiro Yasui, MD, PhD | Posted on: 01 Sep 2022
Taguchi K, Hamamoto S, Okada A, et al. A randomized, single-blind clinical trial comparing robotic-assisted fluoroscopic-guided
with ultrasound-guided renal Access for percutaneous nephrolithotomy. J Urol. 2022;208(3)684-694.
Study Need and Importance
Percutaneous nephrolithotomy (PCNL) is an efficient procedure and thereby is the gold standard for the treatment of large renal stones. However, creating an accurate percutaneous needle puncture into the renal collecting system is challenging and has a steep learning curve that requires rigorous training of surgeons for achieving appropriate skills. To address this unmet need for quick and accurate skill acquisition, we developed an artificial intelligence-empowered robotic interventional device called automated needle target with x-ray for percutaneous renal access.
What We Found
In this randomized controlled trial of 71 patients with renal stones, robotic-assisted fluoroscopic (RAF)-guided renal access demonstrated a comparable single puncture success rate (50.0% vs 34.3%), significantly fewer number of needle punctures (1.8 vs 2.5 times) and shorter needle puncture duration (5.5 vs 8.0 minutes) compared to ultrasound (US)-guided access in PCNL when employed by novice surgeons. No differences were seen in stone-free or complication rates between the 2 groups. Interestingly, RAF guidance reduced the required number of needle punctures by 0.73 times (see Figure).
Limitations
Since this was a single-center trial, the results need to be validated worldwide through multicenter trials with a larger case volume. Given our hospital’s consistency with daily practice, we compared RAF guidance with freehand US guidance. Therefore, the results of this study may be more applicable to institutes employing US-guided PCNL than others; this might benefit from a comparison between RAF guidance and freehand fluoroscopic guidance.
Interpretation for Patient Care
RAF-guided PCNL can be performed as safely and effectively as US-guided PCNL, even by novice surgeons. Its benefits for patients with renal stones are more accurate and faster percutaneous access, potentially reducing the perioperative complication rate. Additionally, this technology can potentially reduce the surgeon’s training load and allow for PCNL procedures at a wider range of hospitals.
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