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

Study Overview
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Brief Summary
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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
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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:

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

Conditions
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Kidney Diseases,Cystic

Intervention / Treatment
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* Procedure: microwave ablation
* Procedure: laparoscopic decortication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laparoscopic microwave ablation<br>laparoscopic microwave ablation will be performed before the renal cysts are decorticated | Procedure: microwave ablation<br>* 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<br>|
| Experimental: percutaneous microwave ablation<br>percutaneous microwave ablation will be performed to treat the renal cysts without decorticating. | Procedure: microwave ablation<br>* 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<br>|
| Active Comparator: laparoscopic decortication<br>conventional laparoscopic decortication will be performed to treat the renal cysts. | Procedure: laparoscopic decortication<br>* conventional laparoscopic decortication will be performed to treat the renal cysts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrence |  | 12 months postoperatively | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, microwave, ablation technique