Endoscopic Robot-Assisted Simple Enucleation Versus Standard Robot-Assisted Partial Nephrectomy in the Treatment of T1 Renal Cell Carcinoma
1 other identifier
interventional
380
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2018
CompletedFirst Posted
Study publicly available on registry
August 10, 2018
CompletedStudy Start
First participant enrolled
October 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedApril 6, 2021
April 1, 2021
2 years
August 7, 2018
April 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Rates of positive surgical margin
10 days post surgery
Secondary Outcomes (8)
5-year Progression-free survival
5 to 7 years
absolute change in estimated glomerular filtration rate(eGFR)
baseline, 3 months and 12 months
absolute change in glomerular filtration rate (GFR) of the affected kidney measured by renal scintigraphy
baseline, 3 months and 12 months
blood loss
during surgery
operation time
during surgery
- +3 more secondary outcomes
Study Arms (2)
endoscopic robot-assisted simple enucleation
EXPERIMENTALSimple 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
ACTIVE COMPARATORStandard partial nephrectomy is defined as the excision of the tumor and of an additional margin of healthy peritumor renal parenchyma.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000, China
Related Publications (1)
Lu Q, Zhao X, Zhang S, Wang G, Ji C, Liu G, Fu Y, Xu L, Zhang S, Li X, Gan W, Zhang G, Guo H. Robot-assisted Simple Enucleation Versus Standard Robot-assisted Partial Nephrectomy for Low- or Intermediate-complexity, Clinical T1 Renal Tumors: A Randomized Controlled Noninferiority Trial. Eur Urol Oncol. 2024 Apr;7(2):275-281. doi: 10.1016/j.euo.2023.07.019. Epub 2023 Aug 18.
PMID: 37598032DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hongqian Guo, PhD
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Mask to participant and outcomes assessor.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Study Record Dates
First Submitted
August 7, 2018
First Posted
August 10, 2018
Study Start
October 11, 2018
Primary Completion
October 15, 2020
Study Completion
October 1, 2025
Last Updated
April 6, 2021
Record last verified: 2021-04