Clinical trial NCT01838720: Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage
Official title: Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Cell Carcinoma
Zero Ischemia
Keywords: renal cell carcinoma
ischemia
radio frequency ablation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2013-04-24
Enrollment: 90
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: the absolute change in glomerular ﬁltration rate (GFR) of the aﬀected kidney
timeFrame: baseline and 12 months
Secondary outcomes:
measure: estimated GFR (eGFR)
timeFrame: 12 months
measure: changes in GFR of total kidneys by renal scintigraphyby
timeFrame: baseline and 12 months
measure: blood loss
timeFrame: during surgery
measure: surgical margin
timeFrame: postoperative
measure: postoperative complications
timeFrame: 12 months
measure: progression-free survival
timeFrame: 12 months
measure: local recurrence
timeFrame: 12 months
measure: the absolute change in glomerular ﬁltration rate (GFR) of the aﬀected kidney
timeFrame: baseline and 6 months
measure: estimated GFR (eGFR) of 6 month
timeFrame: 6 month
measure: changes in GFR of total kidneys by renal scintigraphyby of 6 month
timeFrame: 6 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJi Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Yiran Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.