Hybrid APC Therapy in Early Central Lung Neoplasms

Lung Neoplasms Clinical Trial

Official title:

A Multi-Center Clinical Study of the Hybrid APC Therapy in Early Central Lung Neoplasms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03537378
• Other study ID #: SHCHE201801
• Status: Recruiting
• Phase: N/A
• Start date: December 26, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: September 2019
• Source: Shanghai Chest Hospital
• Contact: Xiaoxuan Zheng, MD
• Phone: 86-18918169140
• Email: milozheng59[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Neoplasms

Intervention

Procedure:
• Hybrid APC
• 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. • High-frequency EBUS, could display the boundary between cartilage endomembrane and cartilage, in order to determine the depth of tumor.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Jiayuan Sun	Shanghai Pulmonary Hospital, Shanghai, China, The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful remission rate:	successful remission is defined as absence of intraepithelial neoplasia in biopsies of original locations at 3 months after HybridAPC upon follow up	3 months
Secondary	Complications	possible complications include perforation, bleeding, fever, stenosis, cough and etc.	3 months