AzTrials
AzTrials

Renal Cell CarcinomaNCT03624673

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

A study testing endoscopic robot-assisted simple enucleation and standard robot-assisted partial nephrectomy in people with Renal Cell Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
endoscopic robot-assisted simple enucleation and standard robot-assisted partial nephrectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
380 participants
Where
1 siteChina
Study dates
11 Oct 2018to Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210000

Other trials in China

About this study

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

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.

Read the 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.

Being tested
endoscopic robot-assisted simple enucleation, standard robot-assisted partial nephrectomy
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endoscopic robot-assisted simple enucleationProcedure or surgery

    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 nephrectomyProcedure or surgery

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

Study groups in NCT03624673
Study groupRoleWhat they receive
endoscopic robot-assisted simple enucleationExperimentalSimple 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.
Receives: Procedure: endoscopic robot-assisted simple enucleation
standard robot-assisted partial nephrectomyActive comparatorStandard partial nephrectomy is defined as the excision of the tumor and of an additional margin of healthy peritumor renal parenchyma.
Receives: Procedure: standard robot-assisted partial nephrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rates of positive surgical margin

    Measured: 10 days post surgery

Secondary outcomes (8)

  1. 5-year Progression-free survival

    Measured: 5 to 7 years

  2. absolute change in estimated glomerular filtration rate(eGFR)

    Measured: baseline, 3 months and 12 months

  3. absolute change in glomerular filtration rate (GFR) of the affected kidney measured by renal scintigraphy

    Measured: baseline, 3 months and 12 months

  4. blood loss

    Measured: during surgery

  5. operation time

    Measured: during surgery

  6. warm ischemic time

    Measured: during surgery

  7. hilar clamping, entry into sinus, suturing tumor bed

    Measured: during surgery

  8. intraoperative and postoperative complications

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2018
  2. Study start11 Oct 2018
  3. Primary completion15 Oct 2020
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Outcomes assessor
Enrolment
380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03624673
Sponsor's protocol ID
ERASE Protocol v1.0 20180806
Status last verified
Apr 2021
First submitted
7 Aug 2018
Last updated
6 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37598032

Questions about this trial

What is this clinical trial studying?

A study testing endoscopic robot-assisted simple enucleation and standard robot-assisted partial nephrectomy in people with Renal Cell Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rates of positive surgical margin (time frame: 10 days post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03624673, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in