UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045477
Receipt number R000051918
Scientific Title A randomized Phase 3 trial exploring the utility of addition of cryobiopsy to forceps biopsy using an ultrathin bronchoscope when diagnosing small, peripheral pulmonary lesions
Date of disclosure of the study information 2021/09/14
Last modified on 2023/03/16 22:41:55

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Basic information

Public title

Use of an ultrathin bronchoscope for cryobiopsy of small, peripheral pulmonary lesions

Acronym

Cryobiopsy using an ultrathin bronchoscope (NMC-UT-Cryo 2)

Scientific Title

A randomized Phase 3 trial exploring the utility of addition of cryobiopsy to forceps biopsy using an ultrathin bronchoscope when diagnosing small, peripheral pulmonary lesions

Scientific Title:Acronym

A randomized trial exploring the utility of addition of cryobiopsy to forceps biopsy using an ultrathin bronchoscope when diagnosing small, peripheral pulmonary lesions (NMC-UT-Cryo 2)

Region

Japan


Condition

Condition

Solitary pulmonary lesions

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

1. To compare the histopathological diagnostic yield of combined forceps biopsy and cryobiopsy with forceps biopsy alone using an ultrathin bronchoscope for small peripheral pulmonary lesions

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

1. Histopathological diagnostic yield

Key secondary outcomes

1. Safety
2. Histopathological diagnostic yield according to subtypes
3. Procedural times
4. Histopathological diagnostic yield according to biopsy procedure


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Forceps biopsy and cryobiopsy using an ultrathin bronchoscope

Interventions/Control_2

Forceps biopsy using an ultrathin bronchoscope

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 peripheral pulmonary lesions <= 30 mm in diameter that require biopsy prior to management decision-making
2. 20 years old or more
3. Provision of written informed consent

Key exclusion criteria

1. Any serious, concomitant medical condition
2. Lesion located within the second ellipse from the hilum, as revealed by chest computed tomography
3. Need for a bronchoscopic procedure addressing a non-target lesion in the same setting
4. Lesion near a large vessel
5. Distance < 10 mm between the visceral pleura and the central margin of the lesion
6. Prior enrollment in this trial
7. Patients who have undergone or will undergo bronchoscopy between the provision of consent and initiation of the study
8. Pregnancy
9. Inability to temporarily interrupt anticoagulant/antiplatelet agents
10. Bleeding tendency
11. Any other clinical issue identified by a study investigator

Target sample size

330


Research contact person

Name of lead principal investigator

1st name Masahide
Middle name
Last name Oki

Organization

National Hospital Organization Nagoya Medical Center

Division name

Department of Respiratory Medicine

Zip code

460-0001

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 Masahide
Middle name
Last name Oki

Organization

National Hospital Organization Nagoya Medical Center

Division name

Department of Respiratory Medicine

Zip code

460-0001

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

National Hospital Organization 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

Institutional Review Board, National Hospital Organization Nagoya Medical Center

Address

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

Tel

052-951-1111

Email

311-rec@mail.hosp.go.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

国立病院機構名古屋医療センター (愛知県)、北海道大学病院 (北海道)、松坂市民病院 (三重県)、松波総合病院 (岐阜県)


Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 14 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

2021 Year 09 Month 07 Day

Date of IRB

2021 Year 09 Month 13 Day

Anticipated trial start date

2021 Year 10 Month 21 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 09 Month 14 Day

Last modified on

2023 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051918


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name