Clinical trial NCT03537378: Hybrid APC Therapy in Early Central Lung Neoplasms
Official title: A Multi-Center Clinical Study of the Hybrid APC Therapy in Early Central Lung Neoplasms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasms
Keywords: Hybrid APC,Early Central Lung Neoplasms,
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Pulmonary Hospital, Shanghai, China
name: The First Affiliated Hospital of Guangzhou Medical University
First posted: 2018-05-25
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Bronchoscopy and fluorescence bronchoscopy found endoluminal growth lesions of upper segmental bronchus. AFB indicates malignant possibility.
2. Size ≤ 20 mm
3. Flat, nodule or polypoid type
4. Negative imaging: HRCT indicates no tumor in lung and lymph node enlargement; or PET-CT finds no lesions in lung or suspicious lymph node tumors involve.
5. Clinical stage: Tis or T1N0M0
6. High-grade intraepithelial neoplasia (including severe atypical dysplasia and carcinoma in situ) mucoepidermoid carcinomaand ,squamous cancer and etc. confirmed by biopsy histopathology
7. High-frequency EBUS indicates the depth of lesions is cartilage endomembrane or internal part of adventitia of tracheal membranous part
8. Patients are not suitable for surgery or refuse surgery
9. Inform consent is available

Exclusion Criteria:

1. Patients with severe cardiopulmonary dysfunction or other contraindication can not tolerate endoscopic examination and treatment
2. Severe bleeding tendency
3. Poor compliance
4. Unstable vital signs
5. Investigators consider subjects should not be included because of specific situations

Primary outcomes:
measure: Successful remission rate:
timeFrame: 3 months
Secondary outcomes:
measure: Complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References: