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

NCT ID: NCT02326558

Last Updated: 2017-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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microwave enucleation

zero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor

Group Type EXPERIMENTAL

laparoscopic microwave ablation-assisted enucleation

Intervention Type PROCEDURE

laparoscopic partial nephrectomy

conventional laparoscopic partial nephrectomy with clamping of the renal artery

Group Type ACTIVE_COMPARATOR

conventional laparoscopic partial nephrectomy

Intervention Type PROCEDURE

Interventions

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laparoscopic microwave ablation-assisted enucleation

Intervention Type PROCEDURE

conventional laparoscopic partial nephrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huang Yi-Ran

Chef of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi-Ran Huang, M.D.

Role: STUDY_CHAIR

RenJi Hospital

Locations

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Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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RenJiH-URO-001

Identifier Type: -

Identifier Source: org_study_id

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