Renal Cell Carcinoma
Conditions
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.
Interventions
PROCEDUREendoscopic 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.
PROCEDUREstandard 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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Mask to participant and outcomes assessor.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of positive surgical margin | 10 days post surgery |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 5-year Progression-free survival | 5 to 7 years |
| warm ischemic time | during surgery |
| hilar clamping, entry into sinus, suturing tumor bed | during surgery |
| intraoperative and postoperative complications | up to 6 months |
| operation time | during surgery |
Countries
China
Outcome results
None listed