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

April 3, 2017 updated by: Huang Yi-Ran, RenJi Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

183

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • RenJi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: microwave enucleation
zero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor
Procedure: laparoscopic microwave ablation-assisted enucleation
Active Comparator: laparoscopic partial nephrectomy
conventional laparoscopic partial nephrectomy with clamping of the renal artery
Procedure: conventional laparoscopic partial nephrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
absolute change in glomerular filtration rate (GFR) of the affected kidney
Time Frame: baseline, 3 months and 12 months
measured by renal scintigraphy
baseline, 3 months and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

National Natural Science Foundation of China

Investigators

  • Study Chair: Yi-Ran Huang, M.D., RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 29, 2014

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RenJiH-URO-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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