Study of Ablation for the Pulmonary Focal Pure Ground Glass Opacity (pGGO) (pGGO)
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|ClinicalTrials.gov Identifier: NCT01429649|
Recruitment Status : Unknown
Verified September 2011 by Chen Weisheng, Dongfang Hospital.
Recruitment status was: Recruiting
First Posted : September 7, 2011
Last Update Posted : September 7, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Lesions||Procedure: cryotherapy or radiofrequency ablation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Prospective Study of Ablation of Pulmonary Focal Pure Ground Glass Opacity|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||December 2014|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429649
|Contact: Weisheng Chen, MDfirstname.lastname@example.org|
|Fuzhou, Fujian, China, 350025|
|Contact: Yonggang Liang +8659122859888 ext 59388 email@example.com|
|Principal Investigator:||Weisheng Chen, MD||Dongfang Hospital Affiliated to Beijing University of Chinese Medicine|