- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03094949
Comparison Between Partial Nephrectomy and Ablation for Renal Tumor
March 23, 2017 updated by: Ping Liang, Chinese PLA General Hospital
Comparison Between Laparoscopic Partial Nephrectomy and Ultrasound Guided Percutaneous Microwave Ablation for T1a Renal Tumor
The therapeutic effectiveness of ultrasound guided cooled-probe microwave ablation and laparoscopic partial nephrectomy on T1a renal cell carcinoma is compared to find a better approach for renal tumor.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jie Yu, Dr
- Phone Number: 8610-66939530
- Email: yu-jie301@hotmail.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with the RCC of ≤4 cm maximum diameter were included in the study.
Exclusion Criteria:
- Patients having RCCs with vascular invasion, extrarenal spread or with benign renal tumors were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Partial Nephrectomy
a kind of operation for renal tumor
|
The renal capsule is cut in a monopolar fashion around the tumor.
After the renal artery is clamped with a bulldog clamp, cold cutting by scissors into the renal parenchymal boundary of the tumor is performed with an optimal surgical margin (a few millimeters).
After retrograde injection of diluted indigo carmine, continuous suturing of the opened collecting system and transection of the major vessels is performed with intracorporeal knot-tying.
Parenchymal suturing is performed in a continuous fashion.
The 20-30 cm length of thread is used, and a knot is made at the end of the thread.
A large Hem-o-lok polymer clip (Weck Closure System, Research Triangle Park, NC) is attached on the proximal side of the knot.
Before the thread is tightened or cinched, the parenchyma is sutured in a running fashion with three or four stitches without any bolster so that the renal bed is kept in its natural position during the suturing.
|
Experimental: microwave ablation
a kind of minimally invasive therapy by using microwave device for renal tumors
|
Microwave ablation is a technique that uses thermal therapy to induce complete necrosis of tumor in situ by using microwave ablation device.Antenna in the microwave ablation device was percutaneously inserted into the tumor and placed at designated place under US guidance.
For tumors less than 1.5 cm, one antenna was inserted and for tumors measuring 1.5 cm or greater, two antennae were inserted in parallel with an inter-antenna distance of 1.0-2.5 cm, which were used simultaneously during MWA to obtain larger ablation zone.
A 20G thermocouple was inserted about 0.5-1 cm away from the tumor for real-time temperature monitoring during MWA.
MW emission didn't stop until the heat-generated hyperechoic water vapor completely encompassed the entire tumor and the measured temperature reached 60°C or remained above 54°C for at least three minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 5 years
|
using log-rank test
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
local tumor progress(new lesion found adjacent to ablation zone)
Time Frame: 5 years
|
using log-rank test
|
5 years
|
rate of intrarenal metastasis(new lesion found in the treated kidney, but not adjacent to ablation zone)
Time Frame: 5 years
|
using log-rank test
|
5 years
|
rate of extrarenal metastasis(new lesion found outside of treated kidney)
Time Frame: 5 years
|
using log-rank test
|
5 years
|
number of patients with side-effect and major complications
Time Frame: 1 month
|
using chi-square test
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2008
Primary Completion (Anticipated)
July 1, 2017
Study Completion (Anticipated)
September 1, 2017
Study Registration Dates
First Submitted
March 1, 2017
First Submitted That Met QC Criteria
March 23, 2017
First Posted (Actual)
March 29, 2017
Study Record Updates
Last Update Posted (Actual)
March 29, 2017
Last Update Submitted That Met QC Criteria
March 23, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 301jrcs
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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