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

Not Applicable

Active, not recruiting

• Conditions: Renal Cell Carcinoma
• Interventions: Procedure: endoscopic robot-assisted simple enucleation; Procedure: standard robot-assisted partial nephrectomy

• Registration Number: NCT03624673
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-10
• Study Start: 2018-10-11
• Primary Completion: 2020-10-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-06
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

1. patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
2. ECOG score <=1
3. RENAL score <=9
4. patients with normal contralateral renal function
5. patients giving consent to the participation in the current clinical trial

Exclusion Criteria

1. intolerance of robotic surgery
2. metastastic renal cell carcinoma
3. RENAL score >=10
4. entry into collection system or hematuria
5. patients with a history of other renal diseases, such as urinary lithiasis
6. patients with a history of renal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endoscopic robot-assisted simple enucleation	endoscopic robot-assisted simple enucleation	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.
standard robot-assisted partial nephrectomy	standard robot-assisted partial nephrectomy	Standard partial nephrectomy is defined as the excision of the tumor and of an additional margin of healthy peritumor renal parenchyma.

Primary Outcome Measures

Name	Time	Method
Rates of positive surgical margin	10 days post surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China