Renal Cell CarcinomaNCT02326558
Comparison of Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma
A study testing laparoscopic microwave ablation-assisted enucleation and conventional laparoscopic partial nephrectomy in people with Renal Cell Carcinoma, run by RenJi Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma. 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?
- laparoscopic microwave ablation-assisted enucleation and conventional laparoscopic partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Sep 2016
- 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
- exophytic cancer
- distance from the hilar renal vessels and urinary collecting system >= 1cm
- patients with normal contralateral renal function (differential renal function of >40% as determined by renal scintigraphy)
- patients giving consent to the participation in the current clinical trial
Who cannot join
- 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.
About this study
Official title: Comparison of Zero Ischemia Laparoscopic Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma
The purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.
Read the detailed description
Microwave ablation has been widely used in the minimally-invasive treatment of renal tumors. Recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was developed, but the experience was preliminary. This study aims to evaluate the feasibility, safety and efficiency of this technique, particularly its role in the preservation of renal function, in comparison with conventional laparoscopic partial nephrectomy.
- Conditions
- Renal Cell Carcinoma
- Being tested
- laparoscopic microwave ablation-assisted enucleation, conventional laparoscopic partial nephrectomy
- Keywords
- zero ischemia, microwave, ablation, enucleation, renal cell carcinoma
- 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.
laparoscopic microwave ablation-assisted enucleationProcedure or surgery
conventional laparoscopic partial nephrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| microwave enucleation | Experimental | zero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor Receives: Procedure: laparoscopic microwave ablation-assisted enucleation |
| laparoscopic partial nephrectomy | Active comparator | conventional laparoscopic partial nephrectomy with clamping of the renal artery Receives: Procedure: conventional laparoscopic partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute change in glomerular filtration rate (GFR) of the affected kidney
measured by renal scintigraphy
Measured: baseline, 3 months and 12 months
Secondary outcomes (8)
absolute change in eGFR of the affected kidney
Measured: baseline, 3 months, 6 months and 12 months
absolute change in total GFR
measured by renal scintigraphy
Measured: baseline and 6 months
blood loss
Measured: during surgery
operation time
Measured: during surgery
surgical margin
assessed according to the pathology report of the operation specimen
Measured: 1 month
postoperative complications
number of participants with postoperative complications graded by Clavien- Dindo system
Measured: up to 6 months
progression-free survival
Measured: 12 months
local recurrence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionSep 2016
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Huang Yi-Ran, RenJi Hospital
- Investigators
- Yi-Ran Huang, M.D., Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326558
- Sponsor's protocol ID
- RenJiH-URO-001
- Status last verified
- Apr 2017
- First submitted
- 17 Dec 2014
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Zero Ischemia Laparoscopic Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02326558
- Acronym / sponsor ID
- RenJiH-URO-001
- Conditions
- Renal Cell Carcinoma
- Keywords
- zero ischemia, microwave, ablation, enucleation, renal cell carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Dec 2014 (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.
The purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.
Detailed description
Microwave ablation has been widely used in the minimally-invasive treatment of renal tumors. Recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was developed, but the experience was preliminary. This study aims to evaluate the feasibility, safety and efficiency of this technique, particularly its role in the preservation of renal function, in comparison with 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 |
|---|---|---|
| microwave enucleation | Experimental | Procedure: laparoscopic microwave ablation-assisted enucleationzero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor |
| laparoscopic partial nephrectomy | Active comparator | Procedure: conventional laparoscopic partial nephrectomyconventional laparoscopic partial nephrectomy with clamping of the renal artery |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma
- exophytic cancer
- distance from the hilar renal vessels and urinary collecting system >= 1cm
- patients with normal contralateral renal function (differential renal function of >40% as determined by renal scintigraphy)
- patients giving consent to the participation in the current clinical trial
Key exclusion criteria (2 listed)
- patients with a history of other renal diseases, such as urinary lithiasis
- patients with a history of renal surgery
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 |
|---|---|---|
| laparoscopic microwave ablation-assisted enucleation | Procedure or surgery | microwave enucleation |
| conventional laparoscopic partial nephrectomy | Procedure or surgery | laparoscopic partial nephrectomy |
Primary outcome
absolute change in glomerular filtration rate (GFR) of the affected kidney
Time frame: baseline, 3 months and 12 months
measured by renal scintigraphy
8 secondary outcomes
absolute change in eGFR of the affected kidney
Time frame: baseline, 3 months, 6 months and 12 months
absolute change in total GFR
Time frame: baseline and 6 months
blood loss
Time frame: during surgery
operation time
Time frame: during surgery
surgical margin
Time frame: 1 month
postoperative complications
Time frame: up to 6 months
progression-free survival
Time frame: 12 months
local recurrence
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
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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.
Yi-Ran Huang, M.D. study chair
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 laparoscopic microwave ablation-assisted enucleation and conventional 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 5 Apr 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
absolute change in glomerular filtration rate (GFR) of the affected kidney (time frame: baseline, 3 months and 12 months). 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 Apr 2017.