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

NCT ID: NCT03068195

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2020-11-30

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:

Conditions

Kidney Diseases,Cystic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

laparoscopic microwave ablation

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

Group Type: EXPERIMENTAL

microwave ablation

Intervention Type: PROCEDURE

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

percutaneous microwave ablation

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

Group Type: EXPERIMENTAL

microwave ablation

Intervention Type: PROCEDURE

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.

Group Type: ACTIVE_COMPARATOR

laparoscopic decortication

Intervention Type: PROCEDURE

conventional laparoscopic decortication will be performed to treat the renal cysts

Interventions

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

Intervention Type: PROCEDURE

laparoscopic decortication

conventional laparoscopic decortication will be performed to treat the renal cysts

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yiran Huang

Role: STUDY_DIRECTOR

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

Yonghui Chen

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yonghui Chen

Role: CONTACT

cyh1488@163.com

Facility Contacts

Yonghui Chen

Role: primary

cyh1488@163.com

Other Identifiers

RenJiH-20161017

Identifier Type: -

Identifier Source: org_study_id