Efficacy and Safety of Microwave Ablation in BosniakⅠ~ⅡF Cystic Renal Lesions

February 24, 2017 updated by: RenJi Hospital

Efficacy and Safety of Microwave Ablation in BosniakⅠ~ⅡF Cystic Renal Lesions: Clinical Outcomes of a Randomised Controlled Trial

The purpose of this study is to determine whether microwave ablation is more effective in the treatment of simple renal cysts than conventional laparoscopic decortication.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background: Simple renal cysts are the most common renal masses, and occur in half of all patients older than 50 years.They are usually asymptomatic and benign, asymptomatic and discovered incidentally. However, over time, these simple cysts can enlarge, become symptomatic and develop complications, requiring intervention.They can be managed by a variety of surgical and percutaneous methods, including percutaneous aspiration (with or without injection of a sclerosing agent), endoscopic marsupialization or excision, open surgery and laparoscopic cyst excision.Percutaneous aspiration and sclerotherapy have been described as safe and effective methods of managing symptomatic simple renal cysts without the cost and morbidity associated with conventional surgery and laparoscopy.However, laparoscopic decortications and simple aspiration is associated with a high recurrence rate because the cyst wall epithelium is responsible for active liquid production.

Purpose:To determine whether microwave ablation is more effective in the treatment of simple renal cysts than conventional laparoscopic decortication.

Method:

Study Type

Interventional

Enrollment (Anticipated)

300

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 Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with sporadic, unilateral, newly diagnosed Bosniak Ⅰ, Ⅱ and ⅡF renal cyst
  • patients agreeable to participate in this long-term follow-up study
  • patients with normal contralateral renal function (differential renal function of >40% as determined by radionuclide scintigraphy)

Exclusion Criteria:

  • patients' aged >80 years
  • patients not able to tolerate the microwave ablation procedure
  • patients with previous renal surgery or history of any inflammatory conditions of the operative kidney
  • patients with the renal cyst involving urinary collecting system
  • patients with other renal diseases,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney

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: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: laparoscopic microwave ablation
laparoscopic microwave ablation will be performed before the renal cysts are decorticated
Procedure: microwave ablation
KY2000 microwave ablation system was used in the experimental group. A power output of 60 W for 1-3 min for 1-3 cycles to treat the renal cysts according to the cysts size and classification.Percutaneous microwave ablation will be performed under the guidance of ultrasound while the laparoscopic microwave ablation will be performed under direct vision
EXPERIMENTAL: percutaneous microwave ablation
percutaneous microwave ablation will be performed to treat the renal cysts without decorticating.
Procedure: microwave ablation
KY2000 microwave ablation system was used in the experimental group. A power output of 60 W for 1-3 min for 1-3 cycles to treat the renal cysts according to the cysts size and classification.Percutaneous microwave ablation will be performed under the guidance of ultrasound while the laparoscopic microwave ablation will be performed under direct vision
ACTIVE_COMPARATOR: laparoscopic decortication
conventional laparoscopic decortication will be performed to treat the renal cysts.
Procedure: laparoscopic decortication
conventional laparoscopic decortication will be performed to treat the renal cysts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
local recurrence
Time Frame: 12 months postoperatively
12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
operative time
Time Frame: during operation
during operation
postoperative complications
Time Frame: postoperative，up to 30 days
postoperative，up to 30 days
Hospital stay time
Time Frame: time from the date of admission until the date of discharge, up to 2 weeks
time from the date of admission until the date of discharge, up to 2 weeks
quality of life assessed by quality of life questionnaire
Time Frame: postoperative，up to 6 months
postoperative，up to 6 months
change from baseline glomerular filtration rate (GFR) of the affected kidney, 12 months minus baseline
Time Frame: baseline and 12 months
baseline and 12 months

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Investigators

  • Study Director: Yiran Huang, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

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)

November 1, 2016

Primary Completion (ANTICIPATED)

November 1, 2018

Study Completion (ANTICIPATED)

November 1, 2020

Study Registration Dates

First Submitted

February 18, 2017

First Submitted That Met QC Criteria

February 24, 2017

First Posted (ACTUAL)

March 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 24, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RenJiH-20161017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Kidney Diseases,Cystic

Clinical Trials on microwave ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe