Study of Ablation for the Pulmonary Focal Pure Ground Glass Opacity (pGGO) (pGGO)
Recruitment status was: Recruiting
With the advent of CT screening for lung cancer, there is an increase in the detection of pulmonary lesions with focal pure ground-glass opacity (pGGO). The pure Ground-glass opacities can be caused by normal expiration, partial filling of air spaces, partial collapse of alveoli, interstitial thickening, inflammation, oedema, fibrosis, and lepidic proliferation of neoplasm. Precise details of the natural history of focal pure GGO are still largely unclear. A number of differential diagnoses are possible, including inflammatory disease, focal scar, atypical adenomatous hyperplasia (AAH), and adenocarcinoma in situ. Some of pGGOs remained stable over a considerable time. A long doubling time for pGGOs is already known. Therefore, the strategy of treatment for focal pure GGO lesions is still undecided. The major issue is whether or not the doctors should treat these patients at all or wait until the first sign of a solid lesion developes which may take many years.
The purpose of this study is to determine if the ablation therapy is safe and effective for the pulmonary pGGO.
|Pulmonary Lesions||Procedure: cryotherapy or radiofrequency ablation||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Prospective Study of Ablation of Pulmonary Focal Pure Ground Glass Opacity|
- The changing of the lesion [ Time Frame: 3 years ]
To determine the efficacy rate of CT image guided ablation for pulmonary focal pGGO.
To determine the feasibility and safety of CT image guided ablation in patients with pulmonary pGGO.
- The side effect of the therapy. [ Time Frame: 3 years ]Intra and post-operative complications rates. Quality-of-life assessment
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Cryoablation or Radiofrequency ablation for the pGGO
Procedure: cryotherapy or radiofrequency ablation
Cryoablation or Radiofrequency ablation is performed under CT image guidance.
No Intervention: Follow up CT scann
The patients will receive follow up with CT scan every 6-9 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429649
|Contact: Weisheng Chen, MDemail@example.com|
|Fuzhou, Fujian, China, 350025|
|Contact: Yonggang Liang +8659122859888 ext 59388 firstname.lastname@example.org|
|Principal Investigator:||Weisheng Chen, MD||Dongfang Hospital Affiliated to Beijing University of Chinese Medicine|