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

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School380 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

380

Conditions

Renal Cell Carcinoma

Interventions

endoscopic robot-assisted simple enucleationPROCEDURE

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 nephrectomyPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Rates of positive surgical margin

Time frame: 10 days post surgery

Secondary Outcomes

5-year Progression-free survival

Time frame: 5 to 7 years

absolute change in estimated glomerular filtration rate(eGFR)

Time frame: baseline, 3 months and 12 months

absolute change in glomerular filtration rate (GFR) of the affected kidney measured by renal scintigraphy

Time frame: baseline, 3 months and 12 months

blood loss

Time frame: during surgery

operation time

Time frame: during surgery

warm ischemic time

Time frame: during surgery

hilar clamping, entry into sinus, suturing tumor bed

Time frame: during surgery

intraoperative and postoperative complications

Time frame: up to 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.