Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage

Not Applicable

• Conditions: Zero Ischemia; Renal Cell Carcinoma
• Interventions: Procedure: ischemia; Procedure: zero ischemia laparoscopic RFA assisted TE

• Registration Number: NCT01838720
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-14
• Study First Submitted QC: 2013-04-20
• Study First Posted: 2013-04-24
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-12
• Last Update Posted: 2014-08-13
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
conventional laparoscopic partial nephrectomy	ischemia	Renal hilum will be accurately isolated and then the artery only will be clamped during surgery.
zero ischemia laparoscopic RFA assisted TE	zero ischemia 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.

Primary Outcome Measures

Name	Time	Method
the absolute change in glomerular filtration rate (GFR) of the affected kidney	baseline and 12 months	12 months minus baseline

Secondary Outcome Measures

Name	Time	Method
changes in GFR of total kidneys by renal scintigraphyby	baseline and 12 months
blood loss	during surgery
surgical margin	postoperative	pathologic confirm of surgical margin
postoperative complications	12 months
progression-free survival	12 months
local recurrence	12 months
the absolute change in glomerular filtration rate (GFR) of the affected kidney	baseline and 6 months	6 months minus baseline
estimated GFR (eGFR) of 6 month	6 month
changes in GFR of total kidneys by renal scintigraphyby of 6 month	6 month
estimated GFR (eGFR)	12 months

Trial Locations

Locations (1)

RenJi Hospital; 🇨🇳 Shanghai, Shanghai, China