Endoscopic Robot-Assisted Simple Enucleation Versus Standard Robot-Assisted Partial Nephrectomy in the Treatment of T1 Renal Cell Carcinoma

Study Overview
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Brief Summary
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This is a non-inferiority, randomized controlled trial to compare the peri-operative, renal functional and oncologic outcomes of endoscopic robot-assisted simple enucleation(ERASE) and standard robot-assisted partial nephrectomy(RAPN) in the treatment of T1 renal cell carcinoma.

Detailed Description
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Simple enucleation (SE) consists of excising the tumor by blunt dissection following the natural cleavage plane between the peritumoral capsule and the renal parenchyma without removing a visible rim of healthy renal tissue, which appears to reserve more renal parenchyma without compromising oncologic safety, may be an alternative to standard partial nephrectomy (PN). Although published studies showed excellent long-term oncologic results, many urologists still consider SE an unsafe technique with a high risk of incomplete tumor excision. The aim of this study is to compare the peri-operative, renal functional and oncologic outcomes of endoscopic robot-assisted simple enucleation(ERASE) and standard robot-assisted partial nephrectomy(RAPN) in the treatment of T1 renal cell carcinoma.

Official Title
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Endoscopic Robot-Assisted Simple Enucleation Versus Standard Robot-Assisted Partial Nephrectomy in the Treatment of T1 Renal Cell Carcinoma: A Non-inferiority Randomized Controlled Trial

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Procedure: endoscopic robot-assisted simple enucleation
* Procedure: standard robot-assisted partial nephrectomy


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 ECOG score <=1 RENAL score <=9 patients with normal contralateral renal function patients giving consent to the participation in the current clinical trial Exclusion Criteria: intolerance of robotic surgery metastastic renal cell carcinoma RENAL score >=10 entry into collection system or hematuria 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: 18 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
Interventional Model Description: This is a non-inferiority, randomized controlled trial to compare the peri-operative, renal functional and oncologic outcomes of endoscopic robot-assisted simple enucleation(ERASE) and standard robot-assisted partial nephrectomy(RAPN) in the treatment of T1 renal cell carcinoma.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endoscopic robot-assisted simple enucleation<br>Simple enucleation consists of excising the tumor by blunt dissection following the natural cleavage plane between the peritumoral capsule and the renal parenchyma without removing a visible rim of healthy renal tissue. | Procedure: endoscopic robot-assisted simple enucleation<br>* Simple enucleation consists of excising the tumor by blunt dissection following the natural cleavage plane between the peritumoral capsule and the renal parenchyma without removing a visible rim of healthy renal tissue.<br>|
| Active Comparator: standard robot-assisted partial nephrectomy<br>Standard partial nephrectomy is defined as the excision of the tumor and of an additional margin of healthy peritumor renal parenchyma. | Procedure: standard robot-assisted partial nephrectomy<br>* Standard partial nephrectomy is defined as the excision of the tumor and of an additional margin of healthy peritumor renal parenchyma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of positive surgical margin |  | 10 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year Progression-free survival |  | 5 to 7 years | 
| absolute change in estimated glomerular filtration rate(eGFR) |  | baseline, 3 months and 12 months | 
| absolute change in glomerular filtration rate (GFR) of the affected kidney measured by renal scintigraphy |  | baseline, 3 months and 12 months | 
| blood loss |  | during surgery | 
| operation time |  | during surgery | 
| warm ischemic time |  | during surgery | 
| hilar clamping, entry into sinus, suturing tumor bed |  | during surgery | 
| intraoperative and postoperative complications |  | up to 6 months |