Renal Cell CarcinomaNCT01838720
Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage
A study testing zero ischemia laparoscopic RFA assisted TE and ischemia in people with Renal Cell Carcinoma and Zero Ischemia, run by RenJi Hospital at 1 site in China.
Trial summary
To evaluate the feasibility and efficiency of zero ischemia laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional laparoscopic partial nephrectomy. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Renal Cell Carcinoma, Zero Ischemia
- What is being tested?
- zero ischemia laparoscopic RFA assisted TE and ischemia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Oct 2014
- 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 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
- 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 close to the calyces
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
RenJi Hospital
Shanghai, Shanghai Municipality, 200127
Yiran Huang, M.D., 86-13501835219, yrhuangrenji@163.com
Yiran Huang, M.D.
About this study
Official title: Zero Ischemia 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 laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional laparoscopic partial nephrectomy.
Read the detailed description
Warm ischemic injury is one of the most important factors affecting renal function in partial nephrectomy (PN). Zero ischemia partial nephrectomy technique using renal arterial branch microdissection could protect renal function during surgery, but it requires longer operative time and more blood loss than conventional partial nephrectomy. The technique of zero ischemia laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma appears to be an alternative that eliminates warm ischemia, preserves the maximal parenchyma and is oncologically safe. Our study was designed to evaluate this technique in comparison with the conventional laparoscopic partial nephrectomy.
- Conditions
- Renal Cell Carcinoma, Zero Ischemia
- Being tested
- zero ischemia laparoscopic RFA assisted TE, ischemia
- Keywords
- renal cell carcinoma, ischemia, radio frequency ablation
- Medical subject headings
- Carcinoma, Renal Cell, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zero ischemia laparoscopic RFA assisted TEProcedure or surgery
Also called zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation
ischemiaProcedure or surgery
Also called renal artery will be clamped during surgery.
conventional laparoscopic partial nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| zero ischemia 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 laparoscopic RFA assisted TE |
| conventional laparoscopic partial nephrectomy | Active comparator | Renal hilum will be accurately isolated and then the artery only will be clamped during surgery. Receives: Procedure: ischemia |
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
Secondary outcomes (10)
estimated GFR (eGFR)
Measured: 12 months
changes in GFR of total kidneys by renal scintigraphyby
Measured: baseline and 12 months
blood loss
Measured: during surgery
surgical margin
pathologic confirm of surgical margin
Measured: postoperative
postoperative complications
Measured: 12 months
progression-free survival
Measured: 12 months
local recurrence
Measured: 12 months
the absolute change in glomerular filtration rate (GFR) of the affected kidney
6 months minus baseline
Measured: baseline and 6 months
estimated GFR (eGFR) of 6 month
Measured: 6 month
changes in GFR of total kidneys by renal scintigraphyby of 6 month
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Yiran Huang, RenJi Hospital
- Investigators
- Yiran Huang, M.D., Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838720
- Sponsor's protocol ID
- RenJiH-20130406
- Status last verified
- Aug 2014
- First submitted
- 14 Apr 2013
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang J, Zhang J, Wang Y, Kong W, Xue W, Liu D, Chen Y, Huang Y. Comparing Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Tumor Enucleation and Laparoscopic Partial Nephrectomy for Clinical T1a Renal Tumor: A Randomized Clinical Trial. J Urol. 2016 Jun;195(6):1677-83. doi: 10.1016/j.juro.2015.12.115. Epub 2016 Feb 22.
PubMed 26905020
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01838720
- Acronym / sponsor ID
- RenJiH-20130406
- Conditions
- Renal Cell Carcinoma, Zero Ischemia
- Keywords
- renal cell carcinoma, ischemia, radio frequency ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Apr 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 24 Apr 2013 (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 laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional laparoscopic partial nephrectomy.
Detailed description
Warm ischemic injury is one of the most important factors affecting renal function in partial nephrectomy (PN). Zero ischemia partial nephrectomy technique using renal arterial branch microdissection could protect renal function during surgery, but it requires longer operative time and more blood loss than conventional partial nephrectomy. The technique of zero ischemia laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma appears to be an alternative that eliminates warm ischemia, preserves the maximal parenchyma and is oncologically safe. Our study was designed to evaluate this technique in comparison with the conventional laparoscopic partial nephrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zero ischemia laparoscopic RFA assisted TE | Experimental | Procedure: zero ischemia 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. |
| conventional laparoscopic partial nephrectomy | Active comparator | Procedure: ischemiaRenal 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 T1a presumed renal cell carcinoma
- 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
- 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 close to the calyces
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 laparoscopic RFA assisted TEAlso: zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation | Procedure or surgery | zero ischemia laparoscopic RFA assisted TE |
| ischemiaAlso: renal artery will be clamped during surgery.conventional laparoscopic partial nephrectomy | Procedure or surgery | conventional 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
10 secondary outcomes
estimated GFR (eGFR)
Time frame: 12 months
changes in GFR of total kidneys by renal scintigraphyby
Time frame: baseline and 12 months
blood loss
Time frame: during surgery
surgical margin
Time frame: postoperative
postoperative complications
Time frame: 12 months
progression-free survival
Time frame: 12 months
local recurrence
Time frame: 12 months
the absolute change in glomerular filtration rate (GFR) of the affected kidney
Time frame: baseline and 6 months
estimated GFR (eGFR) of 6 month
Time frame: 6 month
changes in GFR of total kidneys by renal scintigraphyby of 6 month
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- Derived from this study: PubMed 26905020Huang J, Zhang J, Wang Y, Kong W, Xue W, Liu D, Chen Y, Huang Y. Comparing Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Tumor Enucleation and Laparoscopic Partial Nephrectomy for Clinical T1a Renal Tumor: A Randomized Clinical Trial. J Urol. 2016 Jun;195(6):1677-83. doi: 10.1016/j.juro.2015.12.115. Epub 2016 Feb 22.
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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.
Yiran Huang, M.D. principal investigator
RenJi Hospital
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 laparoscopic RFA assisted TE and ischemia in people with Renal Cell Carcinoma and Zero Ischemia, 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 13 Aug 2014. 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 Yiran Huang, M.D. (86-13501835219, yrhuangrenji@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). 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 NCT01838720, 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 13 Aug 2014.