Zero Ischemia Laparoscopic Radio Frequency/Microwave Ablation Assisted Enucleation of Renal Cell Carcinoma With T1 Stage

Not Applicable

• Conditions: Kidney Neoplasms
• Interventions: Procedure: conventional laparoscopic partial nephrectomy; Procedure: zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)

• Registration Number: NCT02734329
• Lead Sponsor: RenJi Hospital

Brief Summary

Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to T1 RCC patients in randomized clinical trial in multiple centers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-29
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-01
• Last Update Posted: 2016-05-03
• Primary Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
• patients scheduled for laparoscopic nephron sparing surgery
• 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 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional group	conventional laparoscopic partial nephrectomy	Renal hilum will be accurately isolated and then the artery only will be clamped during surgery.
Zero Ischemia group	zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)	Radiofrequency ablation(RFA) /Microwave ablation(MVA) will be performed for 1 to 4 cycles each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping in most cases.

Primary Outcome Measures

Name	Time	Method
the change in glomerular filtration rate (GFR) of the affected kidney	Baseline and 30 months
changes of estimated GFR (eGFR)	Baseline and 30 months

Secondary Outcome Measures

Name	Time	Method
estimated blood loss	during surgery
postoperative complications	postoperative，up to 30 days
progression-free survival rate	through study completion, an average of 3 years
rates of positive surgical margin	postoperative，up to 2 weeks after surgery
operative time	During surgery
the rate of local recurrence	through study completion, an average of 3 years
Hospital stay time	The time from the surgery day to patient discharge, up to 2 weeks

Trial Locations

Locations (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China