UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031270
Receipt number R000035658
Scientific Title Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions
Date of disclosure of the study information 2018/02/15
Last modified on 2022/08/18 09:09:50

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Basic information

Public title

Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions

Acronym

Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions

Scientific Title

Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions

Scientific Title:Acronym

Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions

Region

Japan


Condition

Condition

Benign or malignant pulmonary lesions

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions will be investigated.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rate of reaching the lesion and rate of cases for which cone beam CT was effective

Key secondary outcomes

1. DirectPath
Regions and the bronchial generation order for which virtual images are automatically prepared
Regions and the bronchial generation order for which manual imaging is added
2. Bronchoscopy
Consistency with virtual images
Region and the bronchial generation order allowing insertion
Region and the bronchial generation order observed
3. EBUS
Findings: within, adjacent to, invisible
4. Cone beam CT
Findings: centered, inside, and outside
Number of acquisitions
5. Diagnostic yield
Diagnostic yield (histological diagnostic yield and overall diagnostic yield combining culture, cytology, and histological diagnosis)
Diagnostic yield by the final diagnosis (benign, malignant)
Diagnostic yield by the lesion size (larger or smaller than 2 cm)
Diagnostic yield by the distance of the lesion from the pulmonary hilum (1/3 intermediate, 1/3 lateral)
Diagnostic yield by the pulmonary lobe
Diagnostic yield by the presence or absence of involved bronchus
Diagnostic yield by the character of the lesion (solid, ground glass nodule)
Diagnostic yield by cone beam CT findings
6. Examination and fluoroscopy time and X-ray exposure
Bronchoscopic examination time
Total fluoroscopy time
Cumulative dose area product (DAP) (fluoroscopy, acquisition)
Cumulative Frontal Air Kerma
7. Safety
Complications


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) A 3-cm or smaller peripheral pulmonary lesion is present on chest CT and bronchoscopic examination is necessary to diagnose it or decide on a treatment strategy.
2) The bronchus or pulmonary artery involved in the lesion can be confirmed on chest CT.
3) Age of 20 years old or older
4) SpO2 of 90% or higher
5) Obtainment of written consent to participation in the study directly from the patients.

Key exclusion criteria

1) A lesion is considered present on the central side of the subsegmental bronchus on bronchoscopy.
2) It is clear that the lesion is benign on imaging such as CT.
3) The presence of serious complication which may interfere with examination
4) Oral medication with anticoagulant and antiplatelet agent unable to be discontinued
5) Pregnancy
6) The presence of another complication which may seriously interfere with execution of the examination.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Fumihiro
Middle name
Last name Asano

Organization

Gifu Prefectural General Medical Center

Division name

Department of Pulmonary Medicine

Zip code

5008717

Address

4-6-1, Noishiki, Gifu, Japan

TEL

058-246-1111

Email

asano-fm@ceres.ocn.ne.jp


Public contact

Name of contact person

1st name Fumihiro
Middle name
Last name Asano

Organization

Gifu Prefectural General Medical Center

Division name

Department of Pulmonary Medicine

Zip code

5008717

Address

4-6-1, Noishiki, Gifu, Japan

TEL

058-246-1111

Homepage URL


Email

asano-fm@ceres.ocn.ne.jp


Sponsor or person

Institute

Gifu Prefectural General Medical Center

Institute

Department

Personal name



Funding Source

Organization

Self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gifu Prefectural General Medical Center

Address

4-6-1

Tel

0582461111

Email

asano-fm@ceres.ocn.ne.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2018 Year 02 Month 07 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 13 Day

Last modified on

2022 Year 08 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035658


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name