UMIN-CTR Clinical Trial

Public title

Usefulness of a navigation system "Directpath" in bronchoscopy for pulmonary peripheral lesions

Acronym

Usefulness of a navigation system "Directpath" in bronchoscopy for pulmonary peripheral lesions

Scientific Title

Usefulness of a navigation system "Directpath" in bronchoscopy for pulmonary peripheral lesions

Scientific Title:Acronym

Usefulness of a navigation system "Directpath" in bronchoscopy for pulmonary peripheral lesions

Region

Japan

Condition

Benign or malignant pulmonary lesions

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the usefulness of the navigation system Directpath in bronchoscopy for pulmonary peripheral lesions.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Diagnostic yield

Key secondary outcomes

Directpath
The bronchial generation order allowing automatic virtual image production
The bronchial generation order for which manual registration is added

Bronchoscope
Consistency with virtual images
The bronchial generation order allowing insertion and the outer diameter of the bronchus on virtual images
The distance from the bronchoscope insertion site to the lesion and the number of bronchial divisions
The bronchial generation order allowing observation
The bronchial generation order allowing observation

Diagnostic yield
Diagnostic yields according to the method and bronchoscope used
Diagnostic yield according to the lesion size
Diagnostic yields according to the distance between the lesion and hilum
Diagnosis yields according to the lesion visualization rate using ultrasound, whether the lesion is visualized, and the positional relationship between the ultrasound probe and lesion Visibility on EBUS.
Diagnostic yield according to location of probe in relation to target lesion

Examination time

Safety, Complications

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Virtual images toward pulmonary peripheral lesions are produced using Directpath.
Transbronchial biopsy (TBB) with virtual bronchoscopic navigation (VBN) is performed using a 2.8-mm ultrathin bronchoscope (BF-XP260F; channel inner diameter, 1.2 mm; Olympus). Subsequently, endobronchial ultrasound-guided transbronchial biopsy (EBUS-TBB) /transbronchial needle aspiration (TBNA) with VBN is performed using a 4.0-mm bronchoscope (BF-P260F, inner diameter of the operation channel, 2.0 mm; Olympus).

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. On chest CT images, an abnormal shadow is present in the peripheral area of the lung field, and bronchoscopy is necessary to make a diagnosis or determine treatment principles
2. 20 years of age or older
3. Consent in writing to participate in this study has been obtained from patients themselves

Key exclusion criteria

1. Case with serious concomitant medical illness
2. Central pulmonary lesions
3. Diffuse pulmonary lesions
4. Re-examination due to prior failure in this trial
5. Case with pure ground glass opacity
6. Patients needing to undergo other bronchoscopic procedures (e.g. TBNA, BAL)
7. Bleeding tendency
8. Pregnant woman
9. Other clinical difficulties in this trial

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Fumihiro Asano

Organization

Gifu Prefectural General Medical Center

Division name

Department of Pulmonary Medicine and Bronchoscopy

Zip code

Address

4-6-1, Noishiki, Gifu, Japan

TEL

058-246-1111

Email

Name of contact person

1st name
Middle name
Last name	Akifumi Tsuzuku

Organization

Gifu Prefectural General Medical Center

Division name

Department of Pulmonary Medicine and Bronchoscopy

Zip code

Address

4-6-1, Noishiki, Gifu, Japan

TEL

058-246-1111

Homepage URL

Email

a.tsuzuku@gmail.com

Institute

Gifu Prefectural General Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

岐阜県総合医療センター（岐阜県）

Date of disclosure of the study information

2013

Year

05

Month

23

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

05

Month

23

Day

Date of IRB

Anticipated trial start date

2013

Year

05

Month

23

Day

Last follow-up date

2013

Year

11

Month

30

Day

Date of closure to data entry

2013

Year

12

Month

31

Day

Date trial data considered complete

2013

Year

12

Month

31

Day

Date analysis concluded

2014

Year

05

Month

31

Day

Other related information

Registered date

2013

Year

05

Month

23

Day

Last modified on

2018

Year

06

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012607