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

Nanjing University

Status: Active, not recruiting

Conditions: Renal Cell Carcinoma

Treatments: Procedure: endoscopic robot-assisted simple enucleation; Procedure: standard robot-assisted partial nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03624673

ERASE Protocol v1.0 20180806

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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380 participants in 2 patient groups

endoscopic robot-assisted simple enucleation

Experimental group

Description:

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.

Treatment:

Procedure: endoscopic robot-assisted simple enucleation

standard robot-assisted partial nephrectomy

Active Comparator group

Description:

Standard partial nephrectomy is defined as the excision of the tumor and of an additional margin of healthy peritumor renal parenchyma.

Treatment:

Procedure: standard robot-assisted partial nephrectomy