Zero Ischemia 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 laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional laparoscopic partial nephrectomy.

Detailed Description
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Warm ischemic injury is one of the most important factors affecting renal function in partial nephrectomy (PN). Zero ischemia partial nephrectomy technique using renal arterial branch microdissection could protect renal function during surgery, but it requires longer operative time and more blood loss than conventional partial nephrectomy. The technique of zero ischemia laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma appears to be an alternative that eliminates warm ischemia, preserves the maximal parenchyma and is oncologically safe. Our study was designed to evaluate this technique in comparison with the conventional laparoscopic partial nephrectomy.

Official Title
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Zero Ischemia 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, Zero Ischemia

Intervention / Treatment
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* Procedure: zero ischemia laparoscopic RFA assisted TE
* Procedure: ischemia


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 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 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 close to the calyces

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zero ischemia 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 laparoscopic RFA assisted TE<br> <br> * Other names: zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation;|
| Active Comparator: conventional laparoscopic partial nephrectomy<br>Renal hilum will be accurately isolated and then the artery only will be clamped during surgery. | Procedure: ischemia<br>* conventional laparoscopic partial nephrectomy<br>* Other names: renal artery will be clamped during surgery.;|

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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimated GFR (eGFR) |  | 12 months | 
| changes in GFR of total kidneys by renal scintigraphyby |  | baseline and 12 months | 
| blood loss |  | during surgery | 
| surgical margin | pathologic confirm of surgical margin | postoperative | 
| postoperative complications |  | 12 months | 
| progression-free survival |  | 12 months | 
| local recurrence |  | 12 months | 
| the absolute change in glomerular ﬁltration rate (GFR) of the aﬀected kidney | 6 months minus baseline | baseline and 6 months | 
| estimated GFR (eGFR) of 6 month |  | 6 month | 
| changes in GFR of total kidneys by renal scintigraphyby of 6 month |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal cell carcinoma, ischemia, radio frequency ablation