UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024306
Receipt number R000027995
Scientific Title Effectiveness of additional ultrathin bronchoscopy for peripheral pulmonary lesions to which a radial endobronchial ultrasound (EBUS) probe cannot be advanced during bronchoscopy
Date of disclosure of the study information 2016/10/06
Last modified on 2021/10/21 23:11:29

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Basic information

Public title

Effectiveness of additional ultrathin bronchoscopy for peripheral pulmonary lesions to which a radial endobronchial ultrasound (EBUS) probe cannot be advanced during bronchoscopy

Acronym

Effectiveness of ultrathin bronchoscopy added to bronchoscopy

Scientific Title

Effectiveness of additional ultrathin bronchoscopy for peripheral pulmonary lesions to which a radial endobronchial ultrasound (EBUS) probe cannot be advanced during bronchoscopy

Scientific Title:Acronym

Effectiveness of ultrathin bronchoscopy added to bronchoscopy

Region

Japan


Condition

Condition

Benign or malignant pulmonary lesions

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness of ultrathin bronchoscopy added to bronchoscopy for peripheral pulmonary lesions to which a radial EBUS probe cannot be advanced

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

1. Diagnostic yield of histology specimens

Key secondary outcomes

1. Diagnostic yield: benign or malignant
2. Diagnostic yield according to lesion size: < 20 mm or > 20 mm
3. Diagnostic yield according to lesion location relative to the hilum
4. Diagnostic yield according to lesion location in the bronchopulmonary segment
5. Visibility with EBUS
6. Diagnostic yield according to presence of the air bronchus sign
7. Diagnostic yield according to lesion appearance on CT: solid or ground glass nodule
8. Level of bronchus reached with ultrathin bronchoscope
9. Frequency of reaching the lesion with ultrathin bronchoscope
10. Time required for examination procedure
11. Incidence of adverse effects


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

EBUS-TBB-VBN with an ultrathin bronchoscope

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. Patients with a peripheral pulmonary lesion < 30 mm in size who need to undergo diagnostic bronchoscopy
2. 20 years old or older
3. Informed consent

Key exclusion criteria

1. Serious concomitant medical illness
2. Central pulmonary lesions
3. Lesion located within the inner third ellipse from the hilum on chest CT
4. Re-examination following prior failure in this trial
5. Case with pure ground glass nodule
6. Patients needing to undergo bronchoscopic procedures for non-target lesion in the same setting
7. Diffuse pulmonary lesions
8. Pregnancy
9. Bleeding tendency
10. Other clinical difficulties in this trial

Target sample size

260


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahide Oki

Organization

Nagoya Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan

TEL

052-951-1111

Email

masahideo@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Masahide Oki

Organization

Nagoya Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan

TEL

052-951-1111

Homepage URL


Email

masahideo@gmail.com


Sponsor or person

Institute

Nagoya 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


Address


Tel


Email



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

国立病院機構名古屋医療センター (愛知県)


Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 06 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

Completed

Date of protocol fixation

2016 Year 09 Month 28 Day

Date of IRB

2016 Year 09 Month 29 Day

Anticipated trial start date

2016 Year 10 Month 06 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 10 Month 05 Day

Last modified on

2021 Year 10 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027995


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name