Comparison Between Partial Nephrectomy and Ablation for Renal Tumor
Primary Purpose
Renal Cell Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Partial Nephrectomy
microwave ablation
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring microwave ablation, partial nephrectomy
Eligibility Criteria
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.
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Partial Nephrectomy
microwave ablation
Arm Description
a kind of operation for renal tumor
a kind of minimally invasive therapy by using microwave device for renal tumors
Outcomes
Primary Outcome Measures
overall survival
using log-rank test
Secondary Outcome Measures
local tumor progress(new lesion found adjacent to ablation zone)
using log-rank test
rate of intrarenal metastasis(new lesion found in the treated kidney, but not adjacent to ablation zone)
using log-rank test
rate of extrarenal metastasis(new lesion found outside of treated kidney)
using log-rank test
number of patients with side-effect and major complications
using chi-square test
Full Information
NCT ID
NCT03094949
First Posted
March 1, 2017
Last Updated
March 23, 2017
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03094949
Brief Title
Comparison Between Partial Nephrectomy and Ablation for Renal Tumor
Official Title
Comparison Between Laparoscopic Partial Nephrectomy and Ultrasound Guided Percutaneous Microwave Ablation for T1a Renal Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2008 (Actual)
Primary Completion Date
July 1, 2017 (Anticipated)
Study Completion Date
September 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
microwave ablation, partial nephrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Partial Nephrectomy
Arm Type
Active Comparator
Arm Description
a kind of operation for renal tumor
Arm Title
microwave ablation
Arm Type
Experimental
Arm Description
a kind of minimally invasive therapy by using microwave device for renal tumors
Intervention Type
Procedure
Intervention Name(s)
Partial Nephrectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
microwave ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall survival
Description
using log-rank test
Time Frame
5 years
Secondary Outcome Measure Information:
Title
local tumor progress(new lesion found adjacent to ablation zone)
Description
using log-rank test
Time Frame
5 years
Title
rate of intrarenal metastasis(new lesion found in the treated kidney, but not adjacent to ablation zone)
Description
using log-rank test
Time Frame
5 years
Title
rate of extrarenal metastasis(new lesion found outside of treated kidney)
Description
using log-rank test
Time Frame
5 years
Title
number of patients with side-effect and major complications
Description
using chi-square test
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Yu, Dr
Phone
8610-66939530
Email
yu-jie301@hotmail.com
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Yu, Doctor
Phone
8610-66939530
Email
yu-jie301@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Comparison Between Partial Nephrectomy and Ablation for Renal Tumor
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