Comparison of Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.

Detailed Description
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Microwave ablation has been widely used in the minimally-invasive treatment of renal tumors. Recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was developed, but the experience was preliminary. This study aims to evaluate the feasibility, safety and efficiency of this technique, particularly its role in the preservation of renal function, in comparison with conventional laparoscopic partial nephrectomy.

Official Title
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Comparison of Zero Ischemia Laparoscopic Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Procedure: laparoscopic microwave ablation-assisted enucleation
* Procedure: conventional 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 exophytic cancer distance from the hilar renal vessels and urinary collecting system >= 1cm patients with normal contralateral renal function (differential renal function of >40% as determined by renal scintigraphy) patients giving consent to the participation in the current clinical trial Exclusion Criteria: patients with a history of other renal diseases, such as urinary lithiasis patients with a history of renal surgery

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: microwave enucleation<br>zero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor | Procedure: laparoscopic microwave ablation-assisted enucleation<br> <br> |
| Active Comparator: laparoscopic partial nephrectomy<br>conventional laparoscopic partial nephrectomy with clamping of the renal artery | Procedure: conventional laparoscopic partial nephrectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absolute change in glomerular filtration rate (GFR) of the affected kidney | measured by renal scintigraphy | baseline, 3 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absolute change in eGFR of the affected kidney |  | baseline, 3 months, 6 months and 12 months | 
| absolute change in total GFR | measured by renal scintigraphy | baseline and 6 months | 
| blood loss |  | during surgery | 
| operation time |  | during surgery | 
| surgical margin | assessed according to the pathology report of the operation specimen | 1 month | 
| postoperative complications | number of participants with postoperative complications graded by Clavien- Dindo system | up to 6 months | 
| progression-free survival |  | 12 months | 
| local recurrence |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zero ischemia, microwave, ablation, enucleation, renal cell carcinoma