Hybrid APC Therapy in Early Central Lung Neoplasms

NCT03537378 | Completed DMC

• 1 other identifier: SHCHE201801
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms

Keywords

Hybrid APC,Early Central Lung Neoplasms,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complications

  3 months

Study Arms (1)

Hybrid APC Therapy Group

EXPERIMENTAL

1\) Patients are diagnosed as early central lung neoplasms (severe dysplasia, carcinoma in situ, microinvasive carcinoma，mucoepidermoid carcinoma.etc.) by inquiry of the first doctor, CT test, endoscopy and histopathology. Patients who meet inclusion/exclusion criteria are not suitable for or refuse surgery.

Procedure: Hybrid APC

Interventions

Hybrid APC PROCEDURE

• 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.

Hybrid APC Therapy Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Bronchoscopy and fluorescence bronchoscopy found endoluminal growth lesions of upper segmental bronchus. AFB indicates malignant possibility.
• Size ≤ 20 mm
• Flat, nodule or polypoid type
• 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.
• Clinical stage: Tis or T1N0M0
• High-grade intraepithelial neoplasia (including severe atypical dysplasia and carcinoma in situ) mucoepidermoid carcinomaand ,squamous cancer and etc. confirmed by biopsy histopathology
• High-frequency EBUS indicates the depth of lesions is cartilage endomembrane or internal part of adventitia of tracheal membranous part
• Patients are not suitable for surgery or refuse surgery
• Inform consent is available

You may not qualify if:

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

Sponsors & Collaborators

• Jiayuan Sun: lead
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director,Endoscopy Department,Shanghai Chest Hospital Affiliation: Shanghai Chest Hospital

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: December 26, 2018
• Primary Completion: February 22, 2022
• Study Completion: December 30, 2023
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

CN (1)