Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage

Study Overview
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Brief Summary
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To evaluate the feasibility and efﬁciency of zero ischemia robot-assisted laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with robot-assisted laparoscopic partial nephrectomy without hilar clamping.

Official Title
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Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Procedure: zero ischemia robot-assisted laparoscopic RFA assisted TE
* Procedure: zero ischemia robot-assisted laparoscopic partial nephrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma patients scheduled for robot-assisted laparoscopic nephron sparing surgery patients with normal contralateral renal function (diﬀerential renal function of >40% as determined by radionuclide scintigraphy) patients agreeable to participate in this long-term follow-up study Exclusion Criteria: patients' aged >80 years patients with other renal diseases,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney patients not able to tolerate the robot-assisted laparoscopic procedure patients with previous renal surgery or history of any inﬂammatory conditions of the operative kidney patients with the renal tumor involving urinary collecting system

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted laparoscopic RFA assisted TE<br>RFA will be performed for 1 to 4 cycles for 4 to 12 minutes each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping. | Procedure: zero ischemia robot-assisted laparoscopic RFA assisted TE<br> <br> * Other names: zero ischemia robot-assisted laparoscopic radio frequency ablation assisted tumor enucleation;|
| Active Comparator: Robot-Assisted laparoscopic partial nephrectomy<br>The tumor then will be laparoscopic enucleation without hilar clamping. | Procedure: zero ischemia robot-assisted laparoscopic partial nephrectomy<br> <br> * Other names: Off-clamp robot-assisted partial nephrectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absolute change in glomerular ﬁltration rate (GFR) of the aﬀected kidney | 12 months minus baseline | baseline and 12 months | 
| The changes of estimated GFR (eGFR) | 12 months minus baseline | baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| local recurrence |  | 12 months | 
| operative time |  | During surgery | 
| 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 6 month |  | baseline and 6 months |