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

Primary Purpose

Kidney Diseases,Cystic

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
microwave ablation
laparoscopic decortication
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Diseases,Cystic focused on measuring laparoscopy, microwave, ablation technique

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yonghui ChenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

laparoscopic microwave ablation

percutaneous microwave ablation

laparoscopic decortication

Arm Description

laparoscopic microwave ablation will be performed before the renal cysts are decorticated

percutaneous microwave ablation will be performed to treat the renal cysts without decorticating.

conventional laparoscopic decortication will be performed to treat the renal cysts.

Outcomes

Primary Outcome Measures

local recurrence

Secondary Outcome Measures

postoperative complications
operative time
Hospital stay time
quality of life assessed by quality of life questionnaire
change from baseline glomerular filtration rate (GFR) of the affected kidney, 12 months minus baseline

Full Information

First Posted
February 18, 2017
Last Updated
February 24, 2017
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03068195
Brief Title
Efficacy and Safety of Microwave Ablation in BosniakⅠ~ⅡF Cystic Renal Lesions
Official Title
Efficacy and Safety of Microwave Ablation in BosniakⅠ~ⅡF Cystic Renal Lesions: Clinical Outcomes of a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases,Cystic
Keywords
laparoscopy, microwave, ablation technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic microwave ablation
Arm Type
Experimental
Arm Description
laparoscopic microwave ablation will be performed before the renal cysts are decorticated
Arm Title
percutaneous microwave ablation
Arm Type
Experimental
Arm Description
percutaneous microwave ablation will be performed to treat the renal cysts without decorticating.
Arm Title
laparoscopic decortication
Arm Type
Active Comparator
Arm Description
conventional laparoscopic decortication will be performed to treat the renal cysts.
Intervention Type
Procedure
Intervention Name(s)
microwave ablation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
laparoscopic decortication
Intervention Description
conventional laparoscopic decortication will be performed to treat the renal cysts
Primary Outcome Measure Information:
Title
local recurrence
Time Frame
12 months postoperatively
Secondary Outcome Measure Information:
Title
postoperative complications
Time Frame
postoperative,up to 30 days
Title
operative time
Time Frame
during operation
Title
Hospital stay time
Time Frame
time from the date of admission until the date of discharge, up to 2 weeks
Title
quality of life assessed by quality of life questionnaire
Time Frame
postoperative,up to 6 months
Title
change from baseline glomerular filtration rate (GFR) of the affected kidney, 12 months minus baseline
Time Frame
baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yonghui Chen
Email
cyh1488@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yiran Huang
Organizational Affiliation
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Study Director
Facility Information:
Facility Name
Yonghui Chen
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonghui Chen
Email
cyh1488@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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