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

NCT03068195 | Unknown DMC

• 1 other identifier: RenJiH-20161017
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Diseases,Cystic

Keywords

laparoscopy; microwave; ablation technique

Outcome Measures

Primary Outcomes (1)

• local recurrence

  12 months postoperatively

Secondary Outcomes (5)

• postoperative complications

  postoperative，up to 30 days

• operative time

  during operation

• Hospital stay time

  time from the date of admission until the date of discharge, up to 2 weeks

• quality of life assessed by quality of life questionnaire

  postoperative，up to 6 months

• change from baseline glomerular filtration rate (GFR) of the affected kidney, 12 months minus baseline

  baseline and 12 months

Study Arms (3)

laparoscopic microwave ablation

EXPERIMENTAL

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

Procedure: microwave ablation

percutaneous microwave ablation

EXPERIMENTAL

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

Procedure: microwave ablation

laparoscopic decortication

ACTIVE COMPARATOR

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

Procedure: laparoscopic decortication

Interventions

microwave ablation 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 microwave ablation; percutaneous microwave ablation

laparoscopic decortication PROCEDURE

conventional laparoscopic decortication will be performed to treat the renal cysts

laparoscopic decortication

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Yonghui Chen

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Kidney Diseases, Cystic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yiran Huang

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

  STUDY DIRECTOR

Central Study Contacts

Yonghui Chen

CONTACT

cyh1488@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2017
• First Posted: March 1, 2017
• Study Start: November 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2020
• Last Updated: March 1, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)