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

Not Applicable

• Conditions: Kidney Diseases,Cystic
• Interventions: Procedure: microwave ablation; Procedure: laparoscopic decortication

• Registration Number: NCT03068195
• Lead Sponsor: RenJi Hospital

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:

Study Timeline

• Study Start: 2016-11
• Status Verified: 2017-02
• Study First Submitted: 2017-02-18
• Study First Submitted QC: 2017-02-24
• Last Update Submitted: 2017-02-24
• Study First Posted: 2017-03-01
• Last Update Posted: 2017-03-01
• Primary Completion: 2018-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
percutaneous microwave ablation	microwave ablation	percutaneous microwave ablation will be performed to treat the renal cysts without decorticating.
laparoscopic microwave ablation	microwave ablation	laparoscopic microwave ablation will be performed before the renal cysts are decorticated
laparoscopic decortication	laparoscopic decortication	conventional laparoscopic decortication will be performed to treat the renal cysts.

Primary Outcome Measures

Name	Time	Method
local recurrence	12 months postoperatively

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yonghui Chen; 🇨🇳 Shanghai, Shanghai, China