Kidney Diseases,CysticNCT03068195
Efficacy and Safety of Microwave Ablation in BosniakⅠ~ⅡF Cystic Renal Lesions
A study testing microwave ablation and laparoscopic decortication in people with Kidney Diseases,Cystic, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Diseases,Cystic
- What is being tested?
- microwave ablation and laparoscopic decortication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Yonghui Chen contact
China1 site, 1 recruiting
- Recruiting
Yonghui Chen
Shanghai, Shanghai Municipality
Yonghui Chen, cyh1488@163.com
About this study
Official title: Efficacy and Safety of Microwave Ablation in BosniakⅠ~ⅡF Cystic Renal Lesions: Clinical Outcomes of a Randomised Controlled Trial
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.
Read the 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
- Being tested
- microwave ablation, laparoscopic decortication
- Keywords
- laparoscopy, microwave, ablation technique
- Medical subject headings
- Kidney Diseases, Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microwave ablationProcedure or surgery
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 decorticationProcedure or surgery
conventional laparoscopic decortication will be performed to treat the renal cysts
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic microwave ablation | Experimental | laparoscopic microwave ablation will be performed before the renal cysts are decorticated Receives: Procedure: microwave ablation |
| percutaneous microwave ablation | Experimental | percutaneous microwave ablation will be performed to treat the renal cysts without decorticating. Receives: Procedure: microwave ablation |
| laparoscopic decortication | Active comparator | conventional laparoscopic decortication will be performed to treat the renal cysts. Receives: Procedure: laparoscopic decortication |
What is being measured
The primary outcome is the main question the study is designed to answer.
local recurrence
Measured: 12 months postoperatively
Secondary outcomes (5)
postoperative complications
Measured: postoperative，up to 30 days
operative time
Measured: during operation
Hospital stay time
Measured: time from the date of admission until the date of discharge, up to 2 weeks
quality of life assessed by quality of life questionnaire
Measured: postoperative，up to 6 months
change from baseline glomerular filtration rate (GFR) of the affected kidney, 12 months minus baseline
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study startNov 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Diseases,CysticStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yiran Huang, Study director, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068195
- Sponsor's protocol ID
- RenJiH-20161017
- Status last verified
- Feb 2017
- First submitted
- 18 Feb 2017
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Microwave Ablation in BosniakⅠ~ⅡF Cystic Renal Lesions: Clinical Outcomes of a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03068195
- Acronym / sponsor ID
- RenJiH-20161017
- Conditions
- Kidney Diseases,Cystic
- Keywords
- laparoscopy, microwave, ablation technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| laparoscopic microwave ablation | Experimental | Procedure: microwave ablationlaparoscopic microwave ablation will be performed before the renal cysts are decorticated |
| percutaneous microwave ablation | Experimental | Procedure: microwave ablationpercutaneous microwave ablation will be performed to treat the renal cysts without decorticating. |
| laparoscopic decortication | Active comparator | Procedure: laparoscopic decorticationconventional laparoscopic decortication will be performed to treat the renal cysts. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microwave ablationKY2000 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 | Procedure or surgery | laparoscopic microwave ablation, percutaneous microwave ablation |
| laparoscopic decorticationconventional laparoscopic decortication will be performed to treat the renal cysts | Procedure or surgery | laparoscopic decortication |
Primary outcome
local recurrence
Time frame: 12 months postoperatively
5 secondary outcomes
postoperative complications
Time frame: postoperative，up to 30 days
operative time
Time frame: during operation
Hospital stay time
Time frame: time from the date of admission until the date of discharge, up to 2 weeks
quality of life assessed by quality of life questionnaire
Time frame: postoperative，up to 6 months
change from baseline glomerular filtration rate (GFR) of the affected kidney, 12 months minus baseline
Time frame: baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yonghui Chen contact
Yiran Huang study director
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microwave ablation and laparoscopic decortication in people with Kidney Diseases,Cystic, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonghui Chen (cyh1488@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local recurrence (time frame: 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.