Lung Neoplasms Clinical Trial
Official title:
A Multi-Center Clinical Study of the Hybrid APC Therapy in Early Central Lung Neoplasms
1.1 Aims：This cohort study aims to investigate the clinical value of Hybrid APC for treatment
of early central lung neoplasms.
1.2 methods：A total of 30 patients with early central lung neoplasms will be included in this
open, multicenter, prospective study. Primary observation endpoint is recorded at 3 months
follow-up, and after 3 months patients could be continued to follow up. The data are
expressed in terms of mean and percentage. The categorical variables are analyzed by
chi-square test, and the four table data is analyzed using the exact probability method. The
continuous variable analysis is used by t test. Statistical analysis is performed with SPSS
20.0 software. P < 0.05 is considered statistically significant.
This is a prospective, multicenter, and cohort study. Study subjects: patients with early
central lung neoplasms meet inclusion/exclusion criteria and could receive interventional
therapy.
There are 3 study site in this study and a total of 30 patients with early central lung
cancer will be included.
HybridAPC is integrated with traditional APC and water-jet technique, which has been
successfully applied for endoscopic treatment of mucosal lesions in GI, such as Barrett
esophageal and lesions in colon. Submucosal injection of water jet can elevate superficial
lesion, and then APC can be more effective in ablation of superficial tumor with a protection
for muscular layer. The application of HybridAPC in respiratory intervention could
theoretically protect cartilage, adventitia, reduce damage and formation of scare, and
increase ablation energy to reach radical treatment.
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