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Hybrid APC Therapy in Early Central Lung Neoplasms

Primary Purpose

Lung Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hybrid APC
Sponsored by
Jiayuan Sun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring Hybrid APC,Early Central Lung Neoplasms,

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hybrid APC Therapy Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complications
possible complications include perforation, bleeding, fever, stenosis, cough and etc.

Full Information

First Posted
May 15, 2018
Last Updated
September 2, 2019
Sponsor
Jiayuan Sun
Collaborators
Shanghai Pulmonary Hospital, Shanghai, China, The First Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03537378
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 26, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jiayuan Sun
Collaborators
Shanghai Pulmonary Hospital, Shanghai, China, The First Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
Hybrid APC,Early Central Lung Neoplasms,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hybrid APC Therapy Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hybrid APC
Intervention Description
• 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 Measure Information:
Title
Successful remission rate:
Description
successful remission is defined as absence of intraepithelial neoplasia in biopsies of original locations at 3 months after HybridAPC upon follow up
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Complications
Description
possible complications include perforation, bleeding, fever, stenosis, cough and etc.
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoxuan Zheng, MD
Phone
86-18918169140
Email
milozheng59@163.com
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoxuan Zheng, MD
First Name & Middle Initial & Last Name & Degree
Xiaoxuan Zheng, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Hybrid APC Therapy in Early Central Lung Neoplasms

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