Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage

Not Applicable

• Conditions: Renal Cell Carcinoma
• Interventions: Procedure: zero ischemia robot-assisted laparoscopic partial nephrectomy; Procedure: zero ischemia robot-assisted laparoscopic RFA assisted TE

• Registration Number: NCT02924597
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-10
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-03
• Last Update Submitted: 2016-10-03
• Study First Posted: 2016-10-05
• Last Update Posted: 2016-10-05
• Primary Completion: 2018-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robot-Assisted laparoscopic partial nephrectomy	zero ischemia robot-assisted laparoscopic partial nephrectomy	The tumor then will be laparoscopic enucleation without hilar clamping.
Robot-assisted laparoscopic RFA assisted TE	zero ischemia robot-assisted 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 changes of estimated GFR (eGFR)	baseline and 12 months	12 months minus baseline
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
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
local recurrence	12 months
operative time	During surgery
changes in GFR of total kidneys by renal scintigraphyby of 6 month	baseline and 6 months
Hospital stay time	The time from the surgery day to patient discharge, up to 2 weeks

Trial Locations

Locations (1)

Ethics Committee of Shanghai Renji Hospital; 🇨🇳 Shanghai, Shanghai, China