RecruitingNot ApplicableNCT06715878

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

Zero Ischemia Robot-Assisted Microwave Ablation Assisted Suture-less Enucleation of Renal Cell Carcinoma With T1 Stage: A Randomized Clinical Trial

Sponsor

RenJi Hospital

Enrollment

80 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Kidney Neoplasms

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

Min Age: 15 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a surgical technique for removing small kidney tumors (stage T1 renal cell carcinoma) using a robot-assisted approach with microwave ablation to minimize bleeding and avoid the need for sutures. The aim is to preserve as much healthy kidney tissue as possible. **You may be eligible if...** - You have a newly diagnosed, single kidney tumor (stage T1) in one kidney - You are scheduled for robot-assisted kidney-sparing surgery - Your other kidney is functioning normally - You are willing to participate in long-term follow-up **You may NOT be eligible if...** - You are over 80 years old - You have other kidney diseases (e.g., kidney stones, glomerulonephritis) in the affected kidney - You cannot tolerate robotic surgery - You have had previous surgery on that kidney or a history of kidney inflammation - The tumor is very close to or involves the kidney's drainage system Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREZero 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.

PROCEDURErobotic-assisted laparoscopic partial nephrectomy

robotic-assisted laparoscopic partial nephrectomy

Locations(1)

Ethics Committee of Shanghai Renji Hospital

Shanghai, China

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NCT06715878

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