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

Shanghai Jiao Tong University

Status: Completed

Conditions: Renal Cell Carcinoma

Treatments: Procedure: laparoscopic microwave ablation-assisted enucleation; Procedure: conventional laparoscopic partial nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02326558

RenJiH-URO-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 183 patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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183 participants in 2 patient groups

microwave enucleation

Experimental group

Description:

zero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor

Treatment:

Procedure: laparoscopic microwave ablation-assisted enucleation

laparoscopic partial nephrectomy

Active Comparator group

Description:

conventional laparoscopic partial nephrectomy with clamping of the renal artery

Treatment:

Procedure: conventional laparoscopic partial nephrectomy