UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028901
Receipt number R000032605
Scientific Title Evaluation of blood flow around the bronchial stump or the bronchial anastomosis by thoracoscopic indocyanine green navigation
Date of disclosure of the study information 2017/09/01
Last modified on 2020/03/03 19:17:49

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Basic information

Public title

Evaluation of blood flow around the bronchial stump or the bronchial anastomosis by thoracoscopic indocyanine green navigation

Acronym

Blood flow around the bronchial stump by ICG navigation

Scientific Title

Evaluation of blood flow around the bronchial stump or the bronchial anastomosis by thoracoscopic indocyanine green navigation

Scientific Title:Acronym

Blood flow around the bronchial stump by ICG navigation

Region

Japan


Condition

Condition

Lung tumor

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is evaluation of blood flow of the bronchial stump or the bronchial anastomosis by thoracoscopic ICG navigation. The blood flow might be relative with postoperative morbidity.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

Evaluation of blood flow around the bronchial stump or the bronchial anastomosis

Key secondary outcomes

Adverse event
Bronchial fistula


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

Treatment

Type of intervention

Medicine

Interventions/Control_1

Evaluation of blood flow around the bronchial stump by ICG navigation

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Lung tumor
Performance status(ECOG) 0-1
Patients maintaing the functions of main organs
Patients with written consent of regstration for this examination

Key exclusion criteria

Patients with high risk for regstration of this examination
Patients who has an allergy for ICG

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Hidetaka
Middle name
Last name Uramoto

Organization

Kanazawa Medical University

Division name

Thoracic Surgery

Zip code

920-0293

Address

1-1 Daigaku, Uchinada, Ishikawa, 920-0293, Japan

TEL

076-286-2211

Email

hidetaka@kanazawa-med.ac.jp


Public contact

Name of contact person

1st name Nozomu
Middle name
Last name Motono

Organization

Kanazawa Medical University

Division name

Thoracic Surgery

Zip code

920-0293

Address

1-1 Daigaku, Uchinada, Ishikawa, 920-0293, Japan

TEL

076-286-2211

Homepage URL


Email

motono@kanazawa-med.ac.jp


Sponsor or person

Institute

Kanazawa Medical University
Department of Thoracic Surgery

Institute

Department

Personal name



Funding Source

Organization

Kanazawa Medical University
Department of Thoracic Surgery

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 Boards of Kanazawa Medical University

Address

1-1 Daigaku, Uchinada

Tel

0762188346

Email

tiken@kanazawa-med.ac.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

金沢医科大学病院(石川県)


Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 Day


Related information

URL releasing protocol

https://kanazawa-med.bvits.com/rinri/Apply/project.aspx?PROJECT_ID=1521

Publication of results

Unpublished


Result

URL related to results and publications

https://kanazawa-med.bvits.com/rinri/Apply/project.aspx?PROJECT_ID=1521

Number of participants that the trial has enrolled

0

Results

None

Results date posted

2020 Year 03 Month 03 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

None

Participant flow

None

Adverse events

None

Outcome measures

None

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2017 Year 08 Month 21 Day

Date of IRB

2017 Year 08 Month 23 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2019 Year 12 Month 31 Day

Date trial data considered complete

2019 Year 12 Month 31 Day

Date analysis concluded

2019 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 08 Month 30 Day

Last modified on

2020 Year 03 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032605


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name