UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023939
Receipt number R000026990
Scientific Title Preoperative bronchoscopic marking using virtual bronchoscopic navigation to improve surgical precision for small lung nodules
Date of disclosure of the study information 2016/10/01
Last modified on 2018/03/08 10:52:25

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Basic information

Public title

Preoperative bronchoscopic marking using virtual bronchoscopic navigation to improve surgical precision for small lung nodules

Acronym

Accurate preoperative bronchoscopic marking for small lung nodules

Scientific Title

Preoperative bronchoscopic marking using virtual bronchoscopic navigation to improve surgical precision for small lung nodules

Scientific Title:Acronym

Accurate preoperative bronchoscopic marking for small lung nodules

Region

Japan


Condition

Condition

Small lung nodules

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safety and efficacy of endobronchial marking on lung surface with ICG and contrast agent.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Accuracy and visibility of markings.

Key secondary outcomes

the rate of complete resection of small lung nodules.


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

Maneuver

Interventions/Control_1

Using bronchoscopy, a catheter was inserted into a selected bronchus close to the pleura. 1 mL of dye (ICG, contrast agent) was injected. This was used as references in the subsequent operation to secure complete resection of small lung nodules. This study includes no control group.

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

Among patients who will undergo surgery at Thoracic Surgery, Kyoto University Hospital, those who clinically needs preoperative marking.

Key exclusion criteria

1 ) Patients with history of allergy to ICG, or contrast agent.
2 ) patients with bronchial asthma .
3 ) Minors and dementia patients.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toyofumi F. Chen-Yoshikawa

Organization

Graduate School of Medicine, Kyoto University

Division name

Thoracic Surgery

Zip code


Address

54 Shogoin Kawahara-cho, Sakyoku, Kyoto

TEL

075-751-4975

Email

fengshic@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toyofumi F. Chen-Yoshikawa

Organization

Graduate School of Medicine, Kyoto University

Division name

Thoracic Surgery

Zip code


Address

54 Shogoin Kawahara-cho, Sakyoku, Kyoto

TEL

075-751-4975

Homepage URL


Email

fengshic@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Thoracic Surgery,
Graduate School of Medicine,
Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Thoracic Surgery,
Graduate School of Medicine,
Kyoto University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

京都大学医学部附属病院(京都)


Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 01 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

2016 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 04 Day

Last follow-up date

2021 Year 11 Month 30 Day

Date of closure to data entry

2021 Year 11 Month 30 Day

Date trial data considered complete

2021 Year 11 Month 30 Day

Date analysis concluded

2021 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 09 Month 05 Day

Last modified on

2018 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026990


Research Plan
Registered date File name
2018/03/08 C1223研究計画書201801014.doc

Research case data specifications
Registered date File name
2018/03/08 ICG_CaseX_ CRF.xlsx

Research case data
Registered date File name