Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage
1 other identifier
interventional
90
1 country
1
Brief 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.
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 Apr 2013
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
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 14, 2013
CompletedFirst Posted
Study publicly available on registry
April 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedAugust 13, 2014
August 1, 2014
1.5 years
April 14, 2013
August 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the absolute change in glomerular filtration rate (GFR) of the affected kidney
12 months minus baseline
baseline and 12 months
Secondary Outcomes (10)
estimated GFR (eGFR)
12 months
changes in GFR of total kidneys by renal scintigraphyby
baseline and 12 months
blood loss
during surgery
surgical margin
postoperative
postoperative complications
12 months
- +5 more secondary outcomes
Study Arms (2)
zero ischemia 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.
conventional laparoscopic partial nephrectomy
ACTIVE COMPARATORRenal hilum will be accurately isolated and then the artery only will be clamped during surgery.
Interventions
conventional laparoscopic partial nephrectomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
- National Natural Science Foundation of Chinacollaborator
Study Sites (1)
RenJi Hospital
Shanghai, Shanghai Municipality, 200127, China
Related Publications (1)
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.
PMID: 26905020DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yiran Huang, M.D.
RenJi Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 14, 2013
First Posted
April 24, 2013
Study Start
April 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
August 13, 2014
Record last verified: 2014-08