Clinical trial NCT03068195: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Diseases,Cystic
Keywords: laparoscopy
microwave
ablation technique
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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

Primary outcomes:
measure: local recurrence
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: postoperative complications
timeFrame: postoperative，up to 30 days
measure: operative time
timeFrame: during operation
measure: Hospital stay time
timeFrame: time from the date of admission until the date of discharge, up to 2 weeks
measure: quality of life assessed by quality of life questionnaire
timeFrame: postoperative，up to 6 months
measure: change from baseline glomerular filtration rate (GFR) of the affected kidney, 12 months minus baseline
timeFrame: baseline and 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yonghui Chen
state: Shanghai
Study officials:
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Yiran Huang
role: STUDY_DIRECTOR
References: