Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 3, 2016
CompletedFirst Posted
Study publicly available on registry
October 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedOctober 5, 2016
October 1, 2016
2.6 years
October 3, 2016
October 3, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
The absolute change in glomerular filtration rate (GFR) of the affected kidney
12 months minus baseline
baseline and 12 months
The changes of estimated GFR (eGFR)
12 months minus baseline
baseline and 12 months
Secondary Outcomes (9)
estimated blood loss
during surgery
changes in GFR of total kidneys by renal scintigraphyby
baseline and 12 months
surgical margin
postoperative，up to 2 weeks after surgery
postoperative complications
postoperative，up to 30 days
progression-free survival
12 months
- +4 more secondary outcomes
Study Arms (2)
Robot-assisted laparoscopic RFA assisted TE
EXPERIMENTALRFA 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 COMPARATORThe tumor then will be laparoscopic enucleation without hilar clamping.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Ethics Committee of Shanghai Renji Hospital
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2016
First Posted
October 5, 2016
Study Start
January 1, 2016
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
October 5, 2016
Record last verified: 2016-10