Renal Cell CarcinomaNCT02924597
Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage
A study testing zero ischemia robot-assisted laparoscopic RFA assisted TE and zero ischemia robot-assisted laparoscopic partial nephrectomy in people with Renal Cell Carcinoma, run by RenJi Hospital at 1 site in China.
Trial summary
To evaluate the feasibility and efficiency of zero ischemia robot-assisted laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with robot-assisted laparoscopic partial nephrectomy without hilar clamping. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- zero ischemia robot-assisted laparoscopic RFA assisted TE and zero ischemia robot-assisted laparoscopic partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Aug 2018
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma
- patients scheduled for robot-assisted laparoscopic nephron sparing surgery
- patients with normal contralateral renal function (differential renal function of >40% as determined by radionuclide scintigraphy)
- patients agreeable to participate in this long-term follow-up study
Who cannot join
- patients' aged >80 years
- patients with other renal diseases,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney
- patients not able to tolerate the robot-assisted laparoscopic procedure
- patients with previous renal surgery or history of any inflammatory conditions of the operative kidney
- patients with the renal tumor involving urinary collecting system
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ethics Committee of Shanghai Renji Hospital
Shanghai, Shanghai Municipality
Qi Lu, +86021-68383364, rjllb3364@163.com
About this study
Official title: Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial
To evaluate the feasibility and efficiency of zero ischemia robot-assisted laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with robot-assisted laparoscopic partial nephrectomy without hilar clamping.
- Conditions
- Renal Cell Carcinoma
- Being tested
- zero ischemia robot-assisted laparoscopic RFA assisted TE, zero ischemia robot-assisted laparoscopic 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.
zero ischemia robot-assisted laparoscopic RFA assisted TEProcedure or surgery
Also called zero ischemia robot-assisted laparoscopic radio frequency ablation assisted tumor enucleation
zero ischemia robot-assisted laparoscopic partial nephrectomyProcedure or surgery
Also called Off-clamp robot-assisted partial nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted laparoscopic RFA assisted TE | Experimental | RFA will be performed for 1 to 4 cycles for 4 to 12 minutes each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping. Receives: Procedure: zero ischemia robot-assisted laparoscopic RFA assisted TE |
| Robot-Assisted laparoscopic partial nephrectomy | Active comparator | The tumor then will be laparoscopic enucleation without hilar clamping. Receives: Procedure: zero ischemia robot-assisted laparoscopic partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute change in glomerular filtration rate (GFR) of the affected kidney
12 months minus baseline
Measured: baseline and 12 months
The changes of estimated GFR (eGFR)
12 months minus baseline
Measured: baseline and 12 months
Secondary outcomes (9)
estimated blood loss
Measured: during surgery
changes in GFR of total kidneys by renal scintigraphyby
Measured: baseline and 12 months
surgical margin
Measured: postoperative，up to 2 weeks after surgery
postoperative complications
Measured: postoperative，up to 30 days
progression-free survival
Measured: 12 months
local recurrence
Measured: 12 months
operative time
Measured: During surgery
Hospital stay time
Measured: The time from the surgery day to patient discharge, up to 2 weeks
changes in GFR of total kidneys by renal scintigraphyby of 6 month
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924597
- Sponsor's protocol ID
- RenJiH-20160829
- Status last verified
- Oct 2016
- First submitted
- 3 Oct 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02924597
- Acronym / sponsor ID
- RenJiH-20160829
- Conditions
- Renal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the feasibility and efficiency of zero ischemia robot-assisted laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with robot-assisted laparoscopic partial nephrectomy without hilar clamping.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted laparoscopic RFA assisted TE | Experimental | Procedure: zero ischemia robot-assisted laparoscopic RFA assisted TERFA will be performed for 1 to 4 cycles for 4 to 12 minutes each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping. |
| Robot-Assisted laparoscopic partial nephrectomy | Active comparator | Procedure: zero ischemia robot-assisted laparoscopic partial nephrectomyThe tumor then will be laparoscopic enucleation without hilar clamping. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma
- patients scheduled for robot-assisted laparoscopic nephron sparing surgery
- patients with normal contralateral renal function (differential renal function of >40% as determined by radionuclide scintigraphy)
- patients agreeable to participate in this long-term follow-up study
Key exclusion criteria (5 listed)
- patients' aged >80 years
- patients with other renal diseases,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney
- patients not able to tolerate the robot-assisted laparoscopic procedure
- patients with previous renal surgery or history of any inflammatory conditions of the operative kidney
- patients with the renal tumor involving urinary collecting system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zero ischemia robot-assisted laparoscopic RFA assisted TEAlso: zero ischemia robot-assisted laparoscopic radio frequency ablation assisted tumor enucleation | Procedure or surgery | Robot-assisted laparoscopic RFA assisted TE |
| zero ischemia robot-assisted laparoscopic partial nephrectomyAlso: Off-clamp robot-assisted partial nephrectomy | Procedure or surgery | Robot-Assisted laparoscopic partial nephrectomy |
Primary outcome
The absolute change in glomerular filtration rate (GFR) of the affected kidney
Time frame: baseline and 12 months
12 months minus baseline
The changes of estimated GFR (eGFR)
Time frame: baseline and 12 months
12 months minus baseline
9 secondary outcomes
estimated blood loss
Time frame: during surgery
changes in GFR of total kidneys by renal scintigraphyby
Time frame: baseline and 12 months
surgical margin
Time frame: postoperative，up to 2 weeks after surgery
postoperative complications
Time frame: postoperative，up to 30 days
progression-free survival
Time frame: 12 months
local recurrence
Time frame: 12 months
operative time
Time frame: During surgery
Hospital stay time
Time frame: The time from the surgery day to patient discharge, up to 2 weeks
changes in GFR of total kidneys by renal scintigraphyby of 6 month
Time frame: baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zero ischemia robot-assisted laparoscopic RFA assisted TE and zero ischemia robot-assisted laparoscopic partial nephrectomy in people with Renal Cell Carcinoma, run by RenJi Hospital 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 4 inclusion and 5 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 5 Oct 2016. 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?
Contact Jin Zhang, PhD. (+8618801967501, rjxuyunze@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absolute change in glomerular filtration rate (GFR) of the affected kidney (time frame: baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2016.