NCT03624673

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2018-10-11
• Primary completion: 2020-10-15
• Completion: 2025-10-01
• First posted: 2018-08-10
• Last updated: 2021-04-06

Locations

1 site across 1 country: China