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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03068195
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Kidney Diseases,Cystic Procedure: microwave ablation Procedure: laparoscopic decortication Not Applicable

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:

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Microwave Ablation in BosniakⅠ~ⅡF Cystic Renal Lesions: Clinical Outcomes of a Randomised Controlled Trial
Actual Study Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2020

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




Primary Outcome Measures :
  1. local recurrence [ Time Frame: 12 months postoperatively ]

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


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068195


Contacts
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Contact: Yonghui Chen cyh1488@163.com

Locations
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China, Shanghai
Yonghui Chen Recruiting
Shanghai, Shanghai, China
Contact: Yonghui Chen       cyh1488@163.com   
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Director: Yiran Huang Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03068195    
Other Study ID Numbers: RenJiH-20161017
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by RenJi Hospital:
laparoscopy
microwave
ablation technique
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Diseases, Cystic
Urologic Diseases