Kidney NeoplasmsNCT02734329
Zero Ischemia Laparoscopic Radio Frequency/Microwave Ablation Assisted Enucleation of Renal Cell Carcinoma With T1 Stage
A study testing conventional laparoscopic partial nephrectomy and zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE) in people with Kidney Neoplasms, run by RenJi Hospital at 1 site in China.
Trial summary
Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Kidney Neoplasms
- What is being tested?
- conventional laparoscopic partial nephrectomy and zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Sep 2020
- 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 T1 presumed renal cell carcinoma
- patients scheduled for laparoscopic nephron sparing surgery
- 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 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
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, 200127
jiwei huang, M.D, 86-21-68383716, jiweihuang@outlook.com
Yiran Huang, M.D
About this study
Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to T1 RCC patients in randomized clinical trial in multiple centers.
- Conditions
- Kidney Neoplasms
- Being tested
- conventional laparoscopic partial nephrectomy, zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)
- Keywords
- Nephron sparing surgery, Zero ischemia, Warm ischemia, Laparoscopic, Radiofrequency ablation, Microwave ablation
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional laparoscopic partial nephrectomyProcedure or surgery
renal artery will be clamped during surgery.
zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Zero Ischemia group | Experimental | Radiofrequency ablation(RFA) /Microwave ablation(MVA) will be performed for 1 to 4 cycles each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping in most cases. Receives: Procedure: zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE) |
| Conventional group | Active comparator | Renal hilum will be accurately isolated and then the artery only will be clamped during surgery. Receives: Procedure: conventional laparoscopic partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in glomerular filtration rate (GFR) of the affected kidney
Measured: Baseline and 30 months
changes of estimated GFR (eGFR)
Measured: Baseline and 30 months
Secondary outcomes (7)
estimated blood loss
Measured: during surgery
rates of positive surgical margin
Measured: postoperative，up to 2 weeks after surgery
postoperative complications
Measured: postoperative，up to 30 days
the rate of local recurrence
Measured: through study completion, an average of 3 years
operative time
Measured: During surgery
Hospital stay time
Measured: The time from the surgery day to patient discharge, up to 2 weeks
progression-free survival rate
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Changzheng Hospital, Changhai Hospital, Shanghai 6th People's Hospital, Fudan University
- Responsible party
- Principal investigator, Yiran Huang, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734329
- Sponsor's protocol ID
- RenJiH-2016006
- Status last verified
- May 2016
- First submitted
- 29 Feb 2016
- Last updated
- 3 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zero Ischemia Laparoscopic Radio Frequency/Microwave Ablation Assisted Enucleation of Renal Cell Carcinoma With T1 Stage
- ClinicalTrials.gov ID
- NCT02734329
- Acronym / sponsor ID
- RenJiH-2016006
- Conditions
- Kidney Neoplasms
- Keywords
- Nephron sparing surgery, Zero ischemia, Warm ischemia, Laparoscopic, Radiofrequency ablation, Microwave ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Changzheng Hospital, Changhai Hospital, Shanghai 6th People's Hospital, Fudan University
- Study start
- Apr 2016
- Primary completion
- Sep 2020 (estimated)
- First posted
- 12 Apr 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.
Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to T1 RCC patients in randomized clinical trial in multiple centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zero Ischemia group | Experimental | Procedure: zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)Radiofrequency ablation(RFA) /Microwave ablation(MVA) will be performed for 1 to 4 cycles each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping in most cases. |
| Conventional group | Active comparator | Procedure: conventional laparoscopic partial nephrectomyRenal hilum will be accurately isolated and then the artery only will be clamped during surgery. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
- patients scheduled for laparoscopic nephron sparing surgery
- 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 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 |
|---|---|---|
| conventional laparoscopic partial nephrectomyrenal artery will be clamped during surgery. | Procedure or surgery | Conventional group |
| zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE) | Procedure or surgery | Zero Ischemia group |
Primary outcome
the change in glomerular filtration rate (GFR) of the affected kidney
Time frame: Baseline and 30 months
changes of estimated GFR (eGFR)
Time frame: Baseline and 30 months
7 secondary outcomes
estimated blood loss
Time frame: during surgery
rates of positive surgical margin
Time frame: postoperative，up to 2 weeks after surgery
postoperative complications
Time frame: postoperative，up to 30 days
the rate of local recurrence
Time frame: through study completion, an average of 3 years
operative time
Time frame: During surgery
Hospital stay time
Time frame: The time from the surgery day to patient discharge, up to 2 weeks
progression-free survival rate
Time frame: through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 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 conventional laparoscopic partial nephrectomy and zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE) in people with Kidney Neoplasms, 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 3 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 3 May 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 jiwei huang, M.D. (862168383776, jiweihuang@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in glomerular filtration rate (GFR) of the affected kidney (time frame: Baseline and 30 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 3 May 2016.