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

Not Applicable

Recruiting

• Conditions: Kidney Neoplasms

• Registration Number: NCT06715878
• Lead Sponsor: RenJi Hospital

Brief 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.

Detailed Description

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. This project is based on the previous research and aims to develop an approach of the combination of intraoperative real time contrast-enhanced ultrasonography technology, sutureless technology and the zero ischemia robot-Assisted tumor enucleation of the kidney. By using the real time contrast-enhanced ultrasonography technology, the current shortcomings of the zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation were overcome. The degree of elimination was monitored during surgery to avoid excessive bleeding caused by insufficient ablation during the surgery. Beside, the difficulty of zero ischemia laparoscopic radio frequency ablation is reduced, and doctors can quickly grasp the learning curve of this technology.

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Status Verified: 2024-12
• Study First Posted: 2024-12-04
• Last Update Submitted: 2024-12-08
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The absolute change in glomerular filtration rate (GFR) of the affected kidney	baseline and 12 months	12 months minus baseline
The changes of estimated GFR (eGFR)	baseline and 12 months	12 months minus baseline

Secondary Outcome Measures

Name	Time	Method
Hospital stay time	The time from the surgery day to patient discharge, up to 2 weeks
changes in GFR of total kidneys by renal scintigraphyby of 3 month	baseline and 3 months
local recurrence	12 months
operative time	During surgery
estimated blood loss	during surgery
changes in GFR of total kidneys by renal scintigraphyby	baseline and 12 months
surgical margin	postoperative up to 2 weeks after surgery
postoperative complications	postoperative up to 30 days
progression-free survival	12 months

Trial Locations

Locations (1)

Ethics Committee of Shanghai Renji Hospital; 🇨🇳 Shanghai, China