Zero Ischemia Laparoscopic Radio Frequency/Microwave Ablation Assisted Enucleation of Renal Cell Carcinoma With T1 Stage

Study Overview
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Brief Summary
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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 T1 RCC patients in randomized clinical trial in multiple centers.

Conditions
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Kidney Neoplasms

Intervention / Treatment
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* Procedure: conventional laparoscopic partial nephrectomy
* Procedure: zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma patients scheduled for laparoscopic nephron sparing surgery 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 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zero Ischemia group<br>Radiofrequency ablation(RFA) /Microwave ablation(MVA) will be performed for 1 to 4 cycles each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping in most cases. | Procedure: zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)<br> <br> |
| Active Comparator: Conventional group<br>Renal hilum will be accurately isolated and then the artery only will be clamped during surgery. | Procedure: conventional laparoscopic partial nephrectomy<br>* renal artery will be clamped during surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in glomerular ﬁltration rate (GFR) of the affected kidney |  | Baseline and 30 months | 
| changes of estimated GFR (eGFR) |  | Baseline and 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimated blood loss |  | during surgery | 
| rates of positive surgical margin |  | postoperative，up to 2 weeks after surgery | 
| postoperative complications |  | postoperative，up to 30 days | 
| the rate of local recurrence |  | through study completion, an average of 3 years | 
| operative time |  | During surgery | 
| Hospital stay time |  | The time from the surgery day to patient discharge, up to 2 weeks | 
| progression-free survival rate |  | through study completion, an average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nephron sparing surgery, Zero ischemia, Warm ischemia, Laparoscopic, Radiofrequency ablation, Microwave ablation