Radiofrequency Ablation of Malignant Pulmonary Nodules

Neoplasms Clinical Trial

Official title:

Efficacy and Safety of Radiofrequency Ablation of Malignant Pulmonary Nodules

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02629978
• Other study ID #: CHN-PLAGH-YY-006
• Status: Active, not recruiting
• Phase: N/A
• First received: December 6, 2015
• Last updated: December 14, 2015
• Start date: October 2015
• Est. completion date: October 2020

Study information

• Verified date: October 2015
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: the Chinese PLA General Hospital Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Multiple Pulmonary Nodules
• Neoplasms

Intervention

Procedure:
• CT-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.

Locations

Country	Name	City	State
China	The Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1- , 3- and 5-year survival rates		up to 5 years after the procedures	No
Primary	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.	During the procedure or up to 5 years after the procedures	Yes
Secondary	changes of the size about the tumor on CT/MRI images	Changes in imaging findings in the ablation zone	After the procedures up to three months	No