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Hybrid APC Therapy in Early Central Lung Neoplasms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537378
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Shanghai Pulmonary Hospital, Shanghai, China
The First Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Jiayuan Sun, Shanghai Chest Hospital

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.


Condition or disease Intervention/treatment Phase
Lung Neoplasms Procedure: Hybrid APC Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Clinical Study of the Hybrid APC Therapy in Early Central Lung Neoplasms
Actual Study Start Date : December 26, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hybrid APC Therapy Group
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
• 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.




Primary Outcome Measures :
  1. Successful remission rate: [ Time Frame: 3 months ]
    successful remission is defined as absence of intraepithelial neoplasia in biopsies of original locations at 3 months after HybridAPC upon follow up


Secondary Outcome Measures :
  1. Complications [ Time Frame: 3 months ]
    possible complications include perforation, bleeding, fever, stenosis, cough and etc.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT03537378


Contacts
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Contact: Xiaoxuan Zheng, MD 86-18918169140 milozheng59@163.com

Locations
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China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Xiaoxuan Zheng, MD         
Principal Investigator: Xiaoxuan Zheng, MD         
Sponsors and Collaborators
Jiayuan Sun
Shanghai Pulmonary Hospital, Shanghai, China
The First Affiliated Hospital of Guangzhou Medical University
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Responsible Party: Jiayuan Sun, Director,Endoscopy Department,Shanghai Chest Hospital Affiliation: Shanghai Chest Hospital, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT03537378    
Other Study ID Numbers: SHCHE201801
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiayuan Sun, Shanghai Chest Hospital:
Hybrid APC,Early Central Lung Neoplasms,
Additional relevant MeSH terms:
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Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases