Clinical trial NCT03624673: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Renal Cell Carcinoma
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rates of positive surgical margin
timeFrame: 10 days post surgery
Secondary outcomes:
measure: 5-year Progression-free survival
timeFrame: 5 to 7 years
measure: absolute change in estimated glomerular filtration rate(eGFR)
timeFrame: baseline, 3 months and 12 months
measure: absolute change in glomerular filtration rate (GFR) of the affected kidney measured by renal scintigraphy
timeFrame: baseline, 3 months and 12 months
measure: blood loss
timeFrame: during surgery
measure: operation time
timeFrame: during surgery
measure: warm ischemic time
timeFrame: during surgery
measure: hilar clamping, entry into sinus, suturing tumor bed
timeFrame: during surgery
measure: intraoperative and postoperative complications
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Hongqian Guo, PhD
role: STUDY_CHAIR
References: