UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014829
Receipt number R000017236
Scientific Title Innovative and correct technique for identification of intersegmental planes by infrared thoracoscopy after transbronchial injection of indocianine green
Date of disclosure of the study information 2014/08/25
Last modified on 2014/08/11 14:38:39

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Basic information

Public title

Innovative and correct technique for identification of intersegmental planes by infrared thoracoscopy after transbronchial injection of indocianine green

Acronym

Identification of lung segment by transbronchial ICG instillation

Scientific Title

Innovative and correct technique for identification of intersegmental planes by infrared thoracoscopy after transbronchial injection of indocianine green

Scientific Title:Acronym

Identification of lung segment by transbronchial ICG instillation

Region

Japan


Condition

Condition

lung tumor

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to determine segmental planes with infrared thoracoscopy by immediate preoperative injection of ICG into the associated bronchus prior to segmentectomy for lung tumors.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

After segmentectomy, we will evaluate the efficacy of ICG instillation for demarking segments by confirming whether residual segments which should be removed still exist and by measuring distance from the segmental plane to the tumor. After operation, we will confirm the correctness of removing the segments by computed tomography.

Key secondary outcomes



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

Device,equipment

Interventions/Control_1

Transbronchial ICG instillation to the resected segments of lung tumor

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. 20 year old or higher
2. the patients who undergo segmentectomy
3. IC was obtained

Key exclusion criteria

1. patients who do not want to entry this study
2. Allegy for iodine
3. Inappropriate patients for this study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuo Sekine

Organization

Tokyo Womens Medical University Yachiyo Medical Center

Division name

Departments of Thoracic Surgery

Zip code


Address

477-96 Owada-Shinden, Yachiyo, Chiba, 276-8524, Japan

TEL

047-450-6000

Email

ysekine@tymc.twmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuo Sekine

Organization

Tokyo Womens Medical University Yachiyo Medical Center

Division name

Departments of Thoracic Surgery

Zip code


Address

477-96 Owada-Shinden, Yachiyo, Chiba, 276-8524, Japan

TEL

047-450-6000

Homepage URL


Email

ysekine@tymc.twmu.ac.jp


Sponsor or person

Institute

Tokyo Womens Medical University Yachiyo Medical Center

Institute

Department

Personal name



Funding Source

Organization

Tokyo Womens Medical University

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



Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 25 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

Preinitiation

Date of protocol fixation

2014 Year 08 Month 11 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 25 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 08 Month 11 Day

Last modified on

2014 Year 08 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017236


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name