NCT02629978

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

December 15, 2015

Status Verified

October 1, 2015

Enrollment Period

5 years

First QC Date

December 6, 2015

Last Update Submit

December 14, 2015

Conditions

NeoplasmsCarcinoma

Keywords

pulmonarylungcancercarcinomanodulemalignantradiofrequency ablationRFA

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • changes of the size about the tumor on CT/MRI images

    After the procedures up to three months

Study Arms (1)

radiofrequency ablation

EXPERIMENTAL

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

Interventions

CT-guided percutaneous radiofrequency ablationPROCEDURE

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.

Also known as: CT-guided percutaneous RFA
radiofrequency ablation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed malignant pulmonary nodules.
  • Patients refuse or are not suitable for surgical resections.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese PLA General Hospital

Beijing, 100853, China

Location

MeSH Terms

Conditions

NeoplasmsCarcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Yueyong Xiao

    The Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department

Study Record Dates

First Submitted

December 6, 2015

First Posted

December 15, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

December 15, 2015

Record last verified: 2015-10

Locations

CN(1)