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Clinical Trials in China / NCT06715878
Recruiting Not applicable

Zero Ischemia Robot-Assisted MWA Assisted Suture-less Tumor Enucleation of RCC With T1 Stage

NCT06715878 · tracked via the Priya Life Science China tracker
Sponsor
RenJi Hospital
Phase
Not applicable
Started
2024-03-01
Last updated
2024-12-10

Condition(s) studied

Kidney Neoplasms

Investigational drug(s) / intervention(s)

Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less Enucleationrobotic-assisted laparoscopic partial nephrectomy

Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less Enucleation: Under the visualization of ultrasound contrast imaging through the operative channel, a microwave ablation probe was inserted into the tumor (at the interface between the tumor and kidney, close to the tumor base). The microwave ablation device was used, with a power setting of 70 W for initiating microwave ablation. Depending on the tumor volume and depth, 1-3 ablation cycles were performed, with each cycle lasting 1-3 minutes. After reaching the pseudocapsule of the tumor, a combination of blunt dissection, sharp cutting, and blunt dissection was employed to separate the tumor from the renal parenchyma . The renal artery was not occluded during the procedure.If intraoperative injury to the collecting system is suspected, the collecting system should be sutured normally, while simultaneously suturing the outer layer of renal parenchyma to prevent urine leakage.

robotic-assisted laparoscopic partial nephrectomy: robotic-assisted laparoscopic partial nephrectomy

Study summary

Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial.

Eligibility

Sex
ALL
Min age
15 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma 2. patients scheduled for robot-assisted laparoscopic nephron sparing surgery 3. patients with normal contralateral renal function (differential renal function of \>40% as determined by radionuclide scintigraphy) 4. patients agreeable to participate in this long-term follow-up study Exclusion Criteria: 1. patients' age \>80 years 2. patients with other renal diseases (including kidney stone, glomerular nephritis, etc.)which might affect the renal function of the operative kidney 3. patients not able to tolerate the robot-assisted laparoscopic procedure 4. patients with previous renal surgery or history of any inflammatory conditions of the operative kidney 5. patients with the renal tumor involving urinary collecting system or distance from the tumor edge to the collecting system ≤ 4 mm

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ethics Committee of Shanghai Renji Hospital Shanghai China Recruiting

More RenJi Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06715878 on ClinicalTrials.gov ↗ ← All trials in China