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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03624673
• Other study ID #: ERASE Protocol v1.0 20180806
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 11, 2018
• Est. completion date: October 2025

Study information

• Verified date: April 2021
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 380
• Est. completion date: October 2025
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of positive surgical margin		10 days post surgery
Secondary	5-year Progression-free survival		5 to 7 years
Secondary	absolute change in estimated glomerular filtration rate(eGFR)		baseline, 3 months and 12 months
Secondary	absolute change in glomerular filtration rate (GFR) of the affected kidney measured by renal scintigraphy		baseline, 3 months and 12 months
Secondary	blood loss		during surgery
Secondary	operation time		during surgery
Secondary	warm ischemic time		during surgery
Secondary	hilar clamping, entry into sinus, suturing tumor bed		during surgery
Secondary	intraoperative and postoperative complications		up to 6 months