Radiofrequency Ablation of Malignant Pulmonary Nodules

Efficacy and Safety of Radiofrequency Ablation of Malignant Pulmonary Nodules

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.

Study Overview

• Status: Unknown
• Conditions: Neoplasms; Carcinoma
• Intervention / Treatment: Procedure: CT-guided percutaneous radiofrequency ablation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100853
    • The Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: radiofrequency ablation; 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.

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.; Other Names: CT-guided percutaneous RFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1- , 3- and 5-year survival rates		up to 5 years after the procedures
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: Yueyong Xiao, The Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: December 6, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 15, 2015

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: carcinoma; lung; radiofrequency ablation; cancer; RFA; pulmonary; malignant; nodule
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: CHN-PLAGH-YY-006