Radiofrequency Ablation of Malignant Pulmonary Nodules

NCT ID: NCT02629978

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2020-10-31

Brief Summary

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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

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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.

Conditions

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Neoplasms Carcinoma

Keywords

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pulmonary lung cancer carcinoma nodule malignant radiofrequency ablation RFA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CT-guided percutaneous radiofrequency ablation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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CT-guided percutaneous RFA

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yueyong Xiao

Director of the Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yueyong Xiao

Role: PRINCIPAL_INVESTIGATOR

The Chinese PLA General Hospital

Locations

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The Chinese PLA General Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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CHN-PLAGH-YY-006

Identifier Type: -

Identifier Source: org_study_id