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Evaluation of robotic assisted fluoroscopic guided percutaneous nephrolithotomy

Robotic assisted percutaneous nephrolithotomy study

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The study was completed in 30 cases in the ultrasound group and 30 cases in the robot group, with an mean age of 57 years old, a mean BMI of 24.21 kg /m2, and a male: female ratio of 36:24. There were 30 cases on the right side and 30 cases on the left side, and 19 cases were staghorn stones.

During the registration period from October 1, 2019 to June 30, 2021, 66 cases obtained consent, and 2 of them requested withdrawal of consent. Of the 64 cumulative cases, 4 were out of indication due to deviation from the protocol and were discontinued. The final case was registered on May 25, 2021, and the observation was completed on December 2, 2021, and the analysis has been completed by now.

1 case- postoperative renal bleeding required embolization owing to the pseudoaneurysm. (Non-serious) 1 case- postoperative pneumothorax drained by a chest tube. (Non-serious)

No difference in the primary endpoint was seen between the two groups: the puncture success rate in a single operator (83.3% in the ultrasound group vs 93.3% in the robot group, p = 0.424), the median number of punctures ( 2.0 times in the ultrasound group vs 1.0 times in the robot group, p = 0.068). The secondary endpoints were not significantly different were between the two groups: the median renal puncture time (ultrasound group = 17.5 minutes, robot group = 14.0 minutes, p = 0.12), the median operation time (ultrasound group = 106.5 minutes, robot group = 111.0 minutes, p = 0.982), the median fluoroscopy time (ultrasound group = 600 seconds, robot group = 660 seconds, p = 0.485), and the perioperative complications (p = 0.741).

In this study, we conducted a single-center, randomized controlled trial, evaluating the safety and efficacy of an AI-empowered robot-assisted device for percutaneous renal access compared with conventional ultrasound guidance. The subjects were patients underwent percutaneous nephrolithotomy due to large renal stones. The study included each 30-cases in the ultrasound or robot group. No differences were seen in the primary and secondary endpoints between the two groups.

July. 01, 2022

No

Not applicable

https://jrct.mhlw.go.jp/latest-detail/jRCTs042190074

Taguchi Kazumi

Nagoya City University Hospital

Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi

ktaguchi@med.nagoya-cu.ac.jp

Taguchi Kazumi

Nagoya City University Hospital

Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi

+81-52-853-8266

ktaguchi@med.nagoya-cu.ac.jp

Complete

Oct. 01, 2019

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) Patients whose age are between 16 and 80 years old, diagnosed with renal and/or upper ureteral stone at Nagoya City University Hospital, and planned for percutaneous nephrolithotomy
2) Stones for 15mm and larger in size
3) Patients who were obtained written informed consent
- obtained written informed consent from themselves if they are 20 years old and older
- obtained written informed consent from themselves and representatives if their age are between 16 and 19 years old

A) women with pregnant or its possibility
B) having active pyelonephritis
C) under anti-platelet/coagulation therapy within 1 week prior surgery
D) difficult status for general/lumber anesthesia judged by anesthesiologist
E) Best supportive care due to terminal carcinoma

Both

urolithiasis

RAF group (30 cases): Performing renal puncuture by ANT-X assisted fluoroscopic guidance during percutaneous nephrolithotomy.
US group (30 cases): Performing renal puncuture by ultrasound guidance during percutaneous nephrolithotomy.

renal stone

nephrolithotomy, robot assist, fluoroscopic guidance, ultrasound guidance, renal puncture

urolithiasis

percutaneous nephrolithotomy

1.success rate of inserting puncture needle from skin to anaimed renal calyx
2.success rate of nephrostomy access for renal collecting system with nephroscope

renal puncture time, fluoroscopic time, total operation time, perioperational complicationrate (hemorrhage needed transfusion, pulmonary embolism, fever more than 38 c degree, SIRS, ureteral injury, other organ injury), length of hospitalization

+81-52-858-7215

Sept. 19, 2019

none