Back to resultsRadiofrequency Ablation of Malignant Pulmonary Nodules
Primary Purpose
Neoplasms, Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CT-guided percutaneous radiofrequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms focused on measuring pulmonary, lung, cancer, carcinoma, nodule, malignant, radiofrequency ablation, RFA
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed malignant pulmonary nodules.
- Patients refuse or are not suitable for surgical resections.
- 1-3 pulmonary nodules , with a maximum tumor diameter ≦30 mm.
- Minimum distance of nodules are at least 10 mm apart from the surrounding tissues as big trachea, primary bronchi, esophagus, great vessels，heart and pleura.
Exclusion Criteria:
- Patients who has uncorrectable coagulation disorders, severe heart or pulmonary failure, or uncontrolled infections.
- With extensive extrapulmonary or intrapulmonary metastasis.
- Have taken anticoagulant as aspirin in one week.
- Target nodules nearby pleura or other important hilum and mediastinum structures.
- With metal implants are adjacent to the target tissues which will be covered with ablation area.
Sites / Locations
- The Chinese PLA General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
radiofrequency ablation
Arm Description
In this group, patients willingly receive CT-guided percutaneous radiofrequency ablation procedures are selected according to the inclusion criteria as follows. After a series of preoperative evaluation and preoperative preparation，the procedures will be performed under the CT guidance. CT/MRI scans will be ordered after 24-48 hours to see if there are complications (such as haemorrhage, pneumothorax and pleural effusion). Regularly follow-up will be carried out for several years after RFA to assess the effectiveness and safety of RFA integratedly.
Outcomes
Primary Outcome Measures
1- , 3- and 5-year survival rates
complication rate
Including puncture-related complications such as pulmonary haemorrhage, hemothorax, pneumothorax, cardiac tamponade, and air embolism and ablation-related complications such as chest pain, pleural reactions, cough, and skin burns.
Secondary Outcome Measures
changes of the size about the tumor on CT/MRI images
Changes in imaging findings in the ablation zone
Full Information
NCT ID
NCT02629978
First Posted
December 6, 2015
Last Updated
December 14, 2015
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02629978
Brief Title
Radiofrequency Ablation of Malignant Pulmonary Nodules
Official Title
Efficacy and Safety of Radiofrequency Ablation of Malignant Pulmonary Nodules
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the outcomes of radiofrequency ablation in the treatment of patients with malignant pulmonary nodules（not exceed 3cm ）who are not suitable candidates for or refuse surgical resection.
Detailed Description
Percutaneous radiofrequency ablation (RFA) is a minimally invasive technique widely used to treat solid tumors. Patients with malignant pulmonary nodules will undergo a series of CT- guided percutaneous RFA procedures. During the procedures，percutaneous needles will be inserted into the target tissues under CT guidance，the needles deliver thermal energy and then destroy the tumors by causing coagulation necrosis via tissue heating. The purpose of this study is to assess the effectiveness and safety of RFA in pulmonary nodules （maximum tumor diameter ≦30 mm） was 10 mm apart from the big trachea, primary bronchi, esophagus, great vessels，heart and pleura. Preoperative and postoperative evaluations，including recent laboratory tests evaluated and imaging studies reviewed，will be performed both before and after the procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Carcinoma
Keywords
pulmonary, lung, cancer, carcinoma, nodule, malignant, radiofrequency ablation, RFA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
radiofrequency ablation
Arm Type
Experimental
Arm Description
In this group, patients willingly receive CT-guided percutaneous radiofrequency ablation procedures are selected according to the inclusion criteria as follows. After a series of preoperative evaluation and preoperative preparation，the procedures will be performed under the CT guidance. CT/MRI scans will be ordered after 24-48 hours to see if there are complications (such as haemorrhage, pneumothorax and pleural effusion). Regularly follow-up will be carried out for several years after RFA to assess the effectiveness and safety of RFA integratedly.
Intervention Type
Procedure
Intervention Name(s)
CT-guided percutaneous radiofrequency ablation
Other Intervention Name(s)
CT-guided percutaneous RFA
Intervention Description
Percutaneous radiofrequency ablation (RFA) is a minimally invasive technique will be performed in patients with malignant pulmonary nodules in this group. RFA kills the tumors by causing coagulation necrosis via tissue heating. The electrode delivers thermal energy will be inserted into the target tissues under the CT guidance to ensure the area of ablation should cover the targets and the lung tissues 0.5-1.0 cm around the tumors. Post-operative scan and laboratory test will be conducted in time.
Primary Outcome Measure Information:
Title
1- , 3- and 5-year survival rates
Time Frame
up to 5 years after the procedures
Title
complication rate
Description
Including puncture-related complications such as pulmonary haemorrhage, hemothorax, pneumothorax, cardiac tamponade, and air embolism and ablation-related complications such as chest pain, pleural reactions, cough, and skin burns.
Time Frame
During the procedure or up to 5 years after the procedures
Secondary Outcome Measure Information:
Title
changes of the size about the tumor on CT/MRI images
Description
Changes in imaging findings in the ablation zone
Time Frame
After the procedures up to three months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed malignant pulmonary nodules.
Patients refuse or are not suitable for surgical resections.
1-3 pulmonary nodules , with a maximum tumor diameter ≦30 mm.
Minimum distance of nodules are at least 10 mm apart from the surrounding tissues as big trachea, primary bronchi, esophagus, great vessels，heart and pleura.
Exclusion Criteria:
Patients who has uncorrectable coagulation disorders, severe heart or pulmonary failure, or uncontrolled infections.
With extensive extrapulmonary or intrapulmonary metastasis.
Have taken anticoagulant as aspirin in one week.
Target nodules nearby pleura or other important hilum and mediastinum structures.
With metal implants are adjacent to the target tissues which will be covered with ablation area.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yueyong Xiao
Organizational Affiliation
The Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
12. IPD Sharing Statement
Learn more about this trial
Radiofrequency Ablation of Malignant Pulmonary Nodules
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