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Feasibility of Thin Cp-EBUS Scope BF-UC290F for the Diagnosis of PPLs

Primary Purpose

Peripheral Pulmonary Nodules

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Linear Ultrasound Bronchoscope BF-UC290F (Olympus)
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Pulmonary Nodules focused on measuring EBUS-TBNA, peripheral pulmonary nodules (PPLs), diagnostic yield

Eligibility Criteria

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

Inclusion Criteria:

  • Patients older than 18 years old.
  • Chest imaging shows the presence of peripheral pulmonary lesions (surrounded by pulmonary parenchyma and located below the segmental bronchus/located at least 2 airway generations from the main carina as seen radiographically.) suspicious of malignancy, 0.8-5cm in greatest diameter in need of bronchoscopic biopsy for clinical purposes, and the investigators consider it possible to be biopsied with BF-UC290F (the bronchus adjacent or leading to the PPLs are ≥5mm in diameter, thus BF-UC290F is able to arrival/access).
  • Patients without contraindications of bronchoscopy.
  • Patients have good medical adherence and signed informed consent.

Exclusion Criteria:

  • Peripheral pulmonary lesion is pure ground-glass opacity.
  • Visible lumen lesions during bronchoscopy
  • The lesions were adjacent to the central airway (trachea, left and right main bronchus, and right middle bronchus), and the biopsies by the Thin Convex Probe EBUS Scope BF-UC290F were conducted without leaf bronchus entry
  • The investigators believe that patient has other conditions that are not suitable for the study.

Sites / Locations

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BF-UC290F for diagnosing PPLs

Arm Description

Thin EBUS endoscope is inserted and used to visualize peripheral pulmonary lesions, and biopsies will be conducted by EBUS-TBNA.

Outcomes

Primary Outcome Measures

Diagnostic yield of BF-UC290F for PPLs
Diagnostic yield is defined as the proportion of peripheral pulmonary lesions (PPLs) diagnosed via endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in all lesions undergoing bronchoscopy biopsy via EBUS-TBNA.

Secondary Outcome Measures

EBUS scope operation time
It is defined as the total time from insertion of the EBUS scope to withdrawal of the EBUS scope
The total time of lesion access
It is defined as the total time from the insertion of the EBUS scope to the arrival confirmed by ultrasound image.
Factors affecting the diagnosis rate
Factors affecting the diagnosis rate, including the nature of the lesions, the size of the lesions, the location of the lesions and so on will be analyzed.
The bronchus level of lesions, and the bronchus level reached with the EBUS scope
Level: Bronchus is level 0, leaf bronchus is level 1, segment bronchus is level 2, sub-segment bronchus is level 3, and so on, such as: LB3a is level 3
Specimen adequacy
The adequacy of specimens obtained by Thin Convex Probe EBUS Scope BF-UC290F for pathological typing, molecular testing, and immune checkpoint detection

Full Information

First Posted
August 21, 2022
Last Updated
August 24, 2022
Sponsor
Shanghai Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05512533
Brief Title
Feasibility of Thin Cp-EBUS Scope BF-UC290F for the Diagnosis of PPLs
Official Title
Feasibility and Safety of Thin Convex Probe EBUS Scope BF-UC290F for the Diagnosis of Peripheral Pulmonary Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital

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
The purpose of the study is to evaluate the diagnostic value and safety of Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS) Scope for peripheral pulmonary lesions (PPLs)
Detailed Description
This study will determine the feasibility of the novel thin convex probe endobronchial ultrasound (TCP-EBUS) Scope for the diagnosis of peripheral pulmonary lesions. The primary end point is to clarify the feasibility of using the thin convex probe EBUS scope to biopsy peripheral pulmonary lesions. The secondary objective is to evaluate operation time, sample adequacy and quality, factors affecting the diagnosis rate, etc. The safety, insertion ability, and operability of the thin convex probe EBUS would also be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Pulmonary Nodules
Keywords
EBUS-TBNA, peripheral pulmonary nodules (PPLs), diagnostic yield

7. Study Design

Primary Purpose
Diagnostic
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
BF-UC290F for diagnosing PPLs
Arm Type
Experimental
Arm Description
Thin EBUS endoscope is inserted and used to visualize peripheral pulmonary lesions, and biopsies will be conducted by EBUS-TBNA.
Intervention Type
Device
Intervention Name(s)
Linear Ultrasound Bronchoscope BF-UC290F (Olympus)
Intervention Description
A thin Olympus EBUS bronchoscope BF-UC290F will be used for all endobronchial ultrasound examinations, and biopsies will be conducted with EBUS needles - the ViziShot 2 22G (Olympus).
Primary Outcome Measure Information:
Title
Diagnostic yield of BF-UC290F for PPLs
Description
Diagnostic yield is defined as the proportion of peripheral pulmonary lesions (PPLs) diagnosed via endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in all lesions undergoing bronchoscopy biopsy via EBUS-TBNA.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
EBUS scope operation time
Description
It is defined as the total time from insertion of the EBUS scope to withdrawal of the EBUS scope
Time Frame
Immediately after each operation
Title
The total time of lesion access
Description
It is defined as the total time from the insertion of the EBUS scope to the arrival confirmed by ultrasound image.
Time Frame
Immediately after Each Operation
Title
Factors affecting the diagnosis rate
Description
Factors affecting the diagnosis rate, including the nature of the lesions, the size of the lesions, the location of the lesions and so on will be analyzed.
Time Frame
Up to 6 months
Title
The bronchus level of lesions, and the bronchus level reached with the EBUS scope
Description
Level: Bronchus is level 0, leaf bronchus is level 1, segment bronchus is level 2, sub-segment bronchus is level 3, and so on, such as: LB3a is level 3
Time Frame
During the procedure
Title
Specimen adequacy
Description
The adequacy of specimens obtained by Thin Convex Probe EBUS Scope BF-UC290F for pathological typing, molecular testing, and immune checkpoint detection
Time Frame
Up to 6 months
Other Pre-specified Outcome Measures:
Title
Safety Outcome: Complication rate
Description
The complications refer to the total of serious adverse events related to the procedure during or within 1 month after the operation
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 18 years old. Chest imaging shows the presence of peripheral pulmonary lesions (surrounded by pulmonary parenchyma and located below the segmental bronchus/located at least 2 airway generations from the main carina as seen radiographically.) suspicious of malignancy, 0.8-5cm in greatest diameter in need of bronchoscopic biopsy for clinical purposes, and the investigators consider it possible to be biopsied with BF-UC290F (the bronchus adjacent or leading to the PPLs are ≥5mm in diameter, thus BF-UC290F is able to arrival/access). Patients without contraindications of bronchoscopy. Patients have good medical adherence and signed informed consent. Exclusion Criteria: Peripheral pulmonary lesion is pure ground-glass opacity. Visible lumen lesions during bronchoscopy The lesions were adjacent to the central airway (trachea, left and right main bronchus, and right middle bronchus), and the biopsies by the Thin Convex Probe EBUS Scope BF-UC290F were conducted without leaf bronchus entry The investigators believe that patient has other conditions that are not suitable for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayuan Sun, MD., PhD.
Phone
86-021-22200000
Ext
1511
Email
jysun1976@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD., PhD.
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
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
Jiayuan Sun, MD
Email
jysun1976@163.com
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33447457
Citation
Zhi X, Wang L, Chen J, Zheng X, Li Y, Sun J. Scoring model of convex probe endobronchial ultrasound multimodal imaging in differentiating benign and malignant lung lesions. J Thorac Dis. 2020 Dec;12(12):7645-7655. doi: 10.21037/jtd-2020-abpd-005.
Results Reference
background
PubMed Identifier
30610852
Citation
Fujino K, Ujiie H, Kinoshita T, Lee CY, Igai H, Inage T, Motooka Y, Gregor A, Suzuki M, Yasufuku K. First Evaluation of the Next-Generation Endobronchial Ultrasound System in Preclinical Models. Ann Thorac Surg. 2019 May;107(5):1464-1471. doi: 10.1016/j.athoracsur.2018.11.068. Epub 2019 Jan 2.
Results Reference
background

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Feasibility of Thin Cp-EBUS Scope BF-UC290F for the Diagnosis of PPLs

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