- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02924597
Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage
October 3, 2016 updated by: RenJi Hospital
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jin Zhang, PhD.
- Phone Number: +8618801967501
- Email: rjxuyunze@163.com
Study Contact Backup
- Name: Yiran Huang, MD.
- Phone Number: +8613501835219
- Email: huangyrrenji@163.com
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China
- Recruiting
- Ethics Committee of Shanghai Renji Hospital
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Contact:
- Qi Lu
- Phone Number: +86021-68383364
- Email: rjllb3364@163.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Robot-assisted laparoscopic RFA assisted TE
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.
|
Other Names:
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Active Comparator: Robot-Assisted laparoscopic partial nephrectomy
The tumor then will be laparoscopic enucleation without hilar clamping.
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The absolute change in glomerular filtration rate (GFR) of the affected kidney
Time Frame: baseline and 12 months
|
12 months minus baseline
|
baseline and 12 months
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The changes of estimated GFR (eGFR)
Time Frame: baseline and 12 months
|
12 months minus baseline
|
baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression-free survival
Time Frame: 12 months
|
12 months
|
changes in GFR of total kidneys by renal scintigraphyby
Time Frame: baseline and 12 months
|
baseline and 12 months
|
local recurrence
Time Frame: 12 months
|
12 months
|
estimated blood loss
Time Frame: during surgery
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during surgery
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postoperative complications
Time Frame: postoperative,up to 30 days
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postoperative,up to 30 days
|
operative time
Time Frame: During surgery
|
During surgery
|
Hospital stay time
Time Frame: The time from the surgery day to patient discharge, up to 2 weeks
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The time from the surgery day to patient discharge, up to 2 weeks
|
surgical margin
Time Frame: postoperative,up to 2 weeks after surgery
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postoperative,up to 2 weeks after surgery
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changes in GFR of total kidneys by renal scintigraphyby of 6 month
Time Frame: baseline and 6 months
|
baseline and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Anticipated)
August 1, 2018
Study Completion (Anticipated)
August 1, 2018
Study Registration Dates
First Submitted
October 3, 2016
First Submitted That Met QC Criteria
October 3, 2016
First Posted (Estimate)
October 5, 2016
Study Record Updates
Last Update Posted (Estimate)
October 5, 2016
Last Update Submitted That Met QC Criteria
October 3, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RenJiH-20160829
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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