Clinical trial NCT06715878: Zero Ischemia Robot-Assisted MWA Assisted Suture-less Tumor Enucleation of RCC With T1 Stage
Official title: Zero Ischemia Robot-Assisted Microwave Ablation Assisted Suture-less Enucleation of Renal Cell Carcinoma With T1 Stage: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Neoplasms
Keywords: Microwave ablation
Nephronsparing surgery
Zero ischemia
suture less
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: The absolute change in glomerular filtration rate (GFR) of the affected kidney
timeFrame: baseline and 12 months
measure: The changes of estimated GFR (eGFR)
timeFrame: baseline and 12 months
Secondary outcomes:
measure: estimated blood loss
timeFrame: during surgery
measure: changes in GFR of total kidneys by renal scintigraphyby
timeFrame: baseline and 12 months
measure: surgical margin
timeFrame: postoperative up to 2 weeks after surgery
measure: postoperative complications
timeFrame: postoperative up to 30 days
measure: progression-free survival
timeFrame: 12 months
measure: local recurrence
timeFrame: 12 months
measure: operative time
timeFrame: During surgery
measure: Hospital stay time
timeFrame: The time from the surgery day to patient discharge, up to 2 weeks
measure: changes in GFR of total kidneys by renal scintigraphyby of 3 month
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ethics Committee of Shanghai Renji Hospital
Study officials:
References: