新型机器人辅助联合经皮肾镜取石术和软性输尿管镜碎石术平台的初步临床经验。

Initial Clinical Experience With a Novel Robotically Assisted Platform for Combined Mini-Percutaneous Nephrolithotomy and Flexible Ureteroscopic Lithotripsy.

机构信息

Department of Urology, University of California Irvine, Orange, California.

Johnson & Johnson MedTech, Redwood City, California.

出版信息

J Urol. 2024 Sep;212(3):483-493. doi: 10.1097/JU.0000000000004079. Epub 2024 Aug 8.

DOI:10.1097/JU.0000000000004079

PMID:39115125

Abstract

PURPOSE

We sought to evaluate the technical feasibility of performing a combined robotically assisted mini-percutaneous nephrolithotomy (PCNL) and flexible ureteroscopy (URS) procedure by a single urologist using the MONARCH Platform, Urology (Johnson & Johnson MedTech, Redwood City, California).

MATERIAL AND METHODS

In this prospective, first-in-human clinical trial, 13 patients underwent robotically-assisted PCNL for renal calculi at the University of California-Irvine, Department of Urology. Successful completion of the procedure was assessed as the primary endpoint. Postoperative adverse events were monitored for 30 days following the completion of the procedure. Stone ablation efficiency was evaluated on postoperative day 30 with low-dose 2-3 mm slice CT scans. Patients were classified according to the maximum length of their residual stone fragments as either absolute stone-free (Grade A), < 2 mm remnants (Grade B), or 2.1-4.0 mm remnants (Grade C).

RESULTS

The combined robotic mini-PCNL and URS procedure was successfully completed in 12 of 13 procedures. No robotic device-related adverse events occurred. Preoperative stone burden was quantified by both maximum linear measurement (median 32.8 mm) as well as by CT-based volume (median 1645.9 mm). Using the unique robotically assisted targeting system, percutaneous access was gained directly through the center of the renal papilla in a single pass in all cases. Median operative time was 187 minutes (range: 83-383 minutes). On postoperative day 30, a 98.7% (range: 72.9%-100.0%) volume reduction was achieved, with 5 Grade A (38.5%), 1 Grade B (7.7%), and 2 Grade C (15.4%). Three patients experienced complications (2 grade 1 and one grade 2 Clavien-Dindo).

CONCLUSIONS

Our preliminary investigation demonstrates the safety, efficacy, and feasibility of a unique robotic-assisted combined mini-PCNL and URS platform.

摘要

目的

我们旨在评估由一位泌尿科医生使用 MONARCH 平台（加利福尼亚州雷德伍德市的 Johnson & Johnson MedTech 公司生产的机器人辅助微创经皮肾镜取石术（PCNL）和软性输尿管镜检查（URS）联合手术的技术可行性。

材料和方法

在这项前瞻性、首例人体临床试验中，加利福尼亚大学欧文分校泌尿科的 13 名患者接受了机器人辅助 PCNL 治疗肾结石。成功完成手术被评估为主要终点。术后 30 天监测不良事件。术后第 30 天，采用低剂量 2-3mm 切片 CT 扫描评估结石消融效率。根据残余结石碎片的最大长度，患者分为绝对无结石（A级）、<2mm 残余物（B 级）或 2.1-4.0mm 残余物（C 级）。

结果

13 例手术中有 12 例成功完成了联合机器人迷你 PCNL 和 URS 手术。没有发生与机器人设备相关的不良事件。术前结石负荷通过最大线性测量（中位数 32.8mm）和基于 CT 的体积（中位数 1645.9mm）进行量化。使用独特的机器人辅助靶向系统，所有病例均通过单次直接经皮肾乳头中心获得经皮通路。中位手术时间为 187 分钟（范围：83-383 分钟）。术后第 30 天，体积减少率达到 98.7%（范围：72.9%-100.0%），其中 5 例为 A 级（38.5%），1 例为 B 级（7.7%），2 例为 C 级（15.4%）。有 3 名患者发生并发症（2 级 1 例，1 级 2 例）。