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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Kidney Diseases,Cystic

Treatments: Procedure: laparoscopic decortication; Procedure: microwave ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03068195

RenJiH-20161017

Details and patient eligibility

About

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.

Full 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:

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

laparoscopic microwave ablation

Experimental group

Description:

laparoscopic microwave ablation will be performed before the renal cysts are decorticated

Treatment:

Procedure: microwave ablation

percutaneous microwave ablation

Experimental group

Description:

percutaneous microwave ablation will be performed to treat the renal cysts without decorticating.

Treatment:

Procedure: microwave ablation

laparoscopic decortication

Active Comparator group

Description:

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

Treatment:

Procedure: laparoscopic decortication