Carcinoma, Neoplasms
Conditions
Keywords
pulmonary, lung, cancer, carcinoma, nodule, malignant, radiofrequency ablation, RFA
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.
Interventions
PROCEDURECT-guided percutaneous radiofrequency ablation
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.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed malignant pulmonary nodules. 2. Patients refuse or are not suitable for surgical resections. 3. 1-3 pulmonary nodules , with a maximum tumor diameter ≦30 mm. 4. 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
1. Patients who has uncorrectable coagulation disorders, severe heart or pulmonary failure, or uncontrolled infections. 2. With extensive extrapulmonary or intrapulmonary metastasis. 3. Have taken anticoagulant as aspirin in one week. 4. Target nodules nearby pleura or other important hilum and mediastinum structures. 5. With metal implants are adjacent to the target tissues which will be covered with ablation area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1- , 3- and 5-year survival rates | up to 5 years after the procedures | — |
| complication rate | During the procedure or up to 5 years after the procedures | 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
| Measure | Time frame | Description |
|---|---|---|
| changes of the size about the tumor on CT/MRI images | After the procedures up to three months | Changes in imaging findings in the ablation zone |
Countries
China
Outcome results
None listed