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

Primary Purpose

Renal Cell Carcinoma

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endoscopic robot-assisted simple enucleation
standard robot-assisted partial nephrectomy
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

endoscopic robot-assisted simple enucleation

standard robot-assisted partial nephrectomy

Arm 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.

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

Outcomes

Primary Outcome Measures

Rates of positive surgical margin

Secondary Outcome Measures

5-year Progression-free survival
absolute change in estimated glomerular filtration rate(eGFR)
absolute change in glomerular filtration rate (GFR) of the affected kidney measured by renal scintigraphy
blood loss
operation time
warm ischemic time
hilar clamping, entry into sinus, suturing tumor bed
intraoperative and postoperative complications

Full Information

First Posted
August 7, 2018
Last Updated
April 2, 2021
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03624673
Brief Title
Endoscopic Robot-Assisted Simple Enucleation Versus Standard Robot-Assisted Partial Nephrectomy in the Treatment of T1 Renal Cell Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2018 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Mask to participant and outcomes assessor.
Allocation
Randomized
Enrollment
380 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endoscopic robot-assisted simple enucleation
Arm Type
Experimental
Arm 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.
Arm Title
standard robot-assisted partial nephrectomy
Arm Type
Active Comparator
Arm Description
Standard partial nephrectomy is defined as the excision of the tumor and of an additional margin of healthy peritumor renal parenchyma.
Intervention Type
Procedure
Intervention Name(s)
endoscopic robot-assisted simple enucleation
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
standard robot-assisted partial nephrectomy
Intervention Description
Standard partial nephrectomy is defined as the excision of the tumor and of an additional margin of healthy peritumor renal parenchyma.
Primary Outcome Measure Information:
Title
Rates of positive surgical margin
Time Frame
10 days post surgery
Secondary Outcome Measure Information:
Title
5-year Progression-free survival
Time Frame
5 to 7 years
Title
absolute change in estimated glomerular filtration rate(eGFR)
Time Frame
baseline, 3 months and 12 months
Title
absolute change in glomerular filtration rate (GFR) of the affected kidney measured by renal scintigraphy
Time Frame
baseline, 3 months and 12 months
Title
blood loss
Time Frame
during surgery
Title
operation time
Time Frame
during surgery
Title
warm ischemic time
Time Frame
during surgery
Title
hilar clamping, entry into sinus, suturing tumor bed
Time Frame
during surgery
Title
intraoperative and postoperative complications
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma ECOG score <=1 RENAL score <=9 patients with normal contralateral renal function patients giving consent to the participation in the current clinical trial Exclusion Criteria: intolerance of robotic surgery metastastic renal cell carcinoma RENAL score >=10 entry into collection system or hematuria patients with a history of other renal diseases, such as urinary lithiasis patients with a history of renal surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongqian Guo, PhD
Organizational Affiliation
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China

12. IPD Sharing Statement

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

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