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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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ClinicalTrials.gov Identifier: NCT03624673
Recruitment Status : Active, not recruiting
First Posted : August 10, 2018
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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.
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 : October 11, 2018
Actual Primary Completion Date : October 15, 2020
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Rates of positive surgical margin [ Time Frame: 10 days post surgery ]

Secondary Outcome Measures :
  1. 5-year Progression-free survival [ Time Frame: 5 to 7 years ]
  2. absolute change in estimated glomerular filtration rate(eGFR) [ Time Frame: baseline, 3 months and 12 months ]
  3. absolute change in glomerular filtration rate (GFR) of the affected kidney measured by renal scintigraphy [ Time Frame: baseline, 3 months and 12 months ]
  4. blood loss [ Time Frame: during surgery ]
  5. operation time [ Time Frame: during surgery ]
  6. warm ischemic time [ Time Frame: during surgery ]
  7. hilar clamping, entry into sinus, suturing tumor bed [ Time Frame: during surgery ]
  8. intraoperative and postoperative complications [ Time Frame: up to 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624673


Locations
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China, Jiangsu
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
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Study Chair: Hongqian Guo, PhD The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
More Information
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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: August 10, 2018    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases