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

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03624673
• Collaborator: (none)
• Enrollment: 380
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 83.7
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Procedure: endoscopic robot-assisted simple enucleation; Procedure: standard robot-assisted partial nephrectomy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 380 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Mask to participant and outcomes assessor.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 11, 2018
• Actual Primary Completion Date: Oct 15, 2020
• Anticipated Study Completion Date: Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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: 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.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures

1. Rates of positive surgical margin [10 days post surgery]

Secondary Outcome Measures

1. 5-year Progression-free survival [5 to 7 years]

2. absolute change in estimated glomerular filtration rate(eGFR) [baseline, 3 months and 12 months]

3. absolute change in glomerular filtration rate (GFR) of the affected kidney measured by renal scintigraphy [baseline, 3 months and 12 months]

4. blood loss [during surgery]

5. operation time [during surgery]

6. warm ischemic time [during surgery]

7. hilar clamping, entry into sinus, suturing tumor bed [during surgery]

8. intraoperative and postoperative complications [up to 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210000

Sponsors and Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

• Study Chair: Hongqian Guo, PhD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hongqian Guo, Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• ClinicalTrials.gov Identifier: NCT03624673
• Other Study ID Numbers: ERASE Protocol v1.0 20180806
• First Posted: Aug 10, 2018
• Last Update Posted: Apr 6, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Renal Cell

Study Results

No Results Posted as of Apr 6, 2021