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

Kidney Diseases,Cystic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03068195
• Other study ID #: RenJiH-20161017
• Status: Recruiting
• Phase: N/A
• First received: February 18, 2017
• Last updated: February 24, 2017
• Start date: November 2016
• Est. completion date: November 2020

Study information

• Verified date: February 2017
• Source: RenJi Hospital
• Contact: Yonghui Chen
• Email: cyh1488[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2020
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with sporadic, unilateral, newly diagnosed Bosniak ?, ? and ?F 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

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Diseases,Cystic

Intervention

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

Locations

Country	Name	City	State
China	Yonghui Chen	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local recurrence		12 months postoperatively
Secondary	postoperative complications		postoperative,up to 30 days
Secondary	operative time		during operation
Secondary	Hospital stay time		time from the date of admission until the date of discharge, up to 2 weeks
Secondary	quality of life assessed by quality of life questionnaire		postoperative,up to 6 months
Secondary	change from baseline glomerular filtration rate (GFR) of the affected kidney, 12 months minus baseline		baseline and 12 months