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

NCT ID: NCT03624673

Last Updated: 2021-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-11

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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Study Groups

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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.

Group Type EXPERIMENTAL

endoscopic robot-assisted simple enucleation

Intervention Type PROCEDURE

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 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.

Group Type ACTIVE_COMPARATOR

standard robot-assisted partial nephrectomy

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Hongqian Guo

Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hongqian Guo, PhD

Role: STUDY_CHAIR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 37598032 (View on PubMed)

Other Identifiers

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ERASE Protocol v1.0 20180806

Identifier Type: -

Identifier Source: org_study_id

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