Comparison of Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma

Not Applicable

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Procedure: laparoscopic microwave ablation-assisted enucleation; Procedure: conventional laparoscopic partial nephrectomy

• Registration Number: NCT02326558
• Lead Sponsor: RenJi Hospital

Brief Summary

The purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.

Detailed Description

Microwave ablation has been widely used in the minimally-invasive treatment of renal tumors. Recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was developed, but the experience was preliminary. This study aims to evaluate the feasibility, safety and efficiency of this technique, particularly its role in the preservation of renal function, in comparison with conventional laparoscopic partial nephrectomy.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-29
• Primary Completion: 2015-10
• Study Completion: 2016-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

• patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma
• exophytic cancer
• distance from the hilar renal vessels and urinary collecting system >= 1cm
• patients with normal contralateral renal function (differential renal function of >40% as determined by renal scintigraphy)
• patients giving consent to the participation in the current clinical trial

Exclusion Criteria

• patients with a history of other renal diseases, such as urinary lithiasis
• patients with a history of renal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
microwave enucleation	laparoscopic microwave ablation-assisted enucleation	zero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor
laparoscopic partial nephrectomy	conventional laparoscopic partial nephrectomy	conventional laparoscopic partial nephrectomy with clamping of the renal artery

Primary Outcome Measures

Name	Time	Method
absolute change in glomerular filtration rate (GFR) of the affected kidney	baseline, 3 months and 12 months	measured by renal scintigraphy

Secondary Outcome Measures

Name	Time	Method
progression-free survival	12 months
blood loss	during surgery
surgical margin	1 month	assessed according to the pathology report of the operation specimen
local recurrence	12 months
absolute change in eGFR of the affected kidney	baseline, 3 months, 6 months and 12 months
absolute change in total GFR	baseline and 6 months	measured by renal scintigraphy
postoperative complications	up to 6 months	number of participants with postoperative complications graded by Clavien- Dindo system
operation time	during surgery

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China