UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021575
Receipt number R000024754
Scientific Title Clinical research for evaluation of organ blood flow by using the ICG fluorescence method during esophagus cancer operations.
Date of disclosure of the study information 2016/03/24
Last modified on 2017/04/24 12:05:45

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Basic information

Public title

Clinical research for evaluation of organ blood flow by using the ICG fluorescence method during esophagus cancer operations.

Acronym

Organ bloodflow evaluation by using the ICG fluorescence method

Scientific Title

Clinical research for evaluation of organ blood flow by using the ICG fluorescence method during esophagus cancer operations.

Scientific Title:Acronym

Organ bloodflow evaluation by using the ICG fluorescence method

Region

Japan


Condition

Condition

esophagus cancer

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate and analyze for blood flow in a gastric wall, gastric tube and the trachea by using ICG during esophagus cancer operations.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

enables the observation of blood flow in a gastric wall, gastric tube and the trachea by using ICG during esophagus cancer operations.

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

Medicine

Interventions/Control_1

indocyanine green 25mg by dissolving with injection solution and use 0.5cc (1.25mg) per time when conducting chest procedure and creating gastric tube.

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 Histologically proven esophagus cancer
2 Aged over 20 at the time of registration
3 Patients conducting surgical operation for esophagus cancer
4 Written IC

Key exclusion criteria

1 Previous history of ICG allergy
2 Any other cases who are regarded as inadequate for study enrollment by the investigator

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Kuwano

Organization

Gunma University Hospital

Division name

Integrative Center of General Surgery

Zip code


Address

3-39-15 Showa-machi Maebashi Gunma 371-8511

TEL

027-220-8224

Email

maksakai@gunma-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makoto Sakai

Organization

Gunma University Hospital

Division name

Integrative Center of General Surgery

Zip code


Address

3-39-15 Showa-machi Maebashi Gunma 371-8511

TEL

027-220-8224

Homepage URL


Email

maksakai@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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

群馬大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 24 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

Date of protocol fixation

2016 Year 02 Month 24 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 01 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

2016 Year 03 Month 23 Day

Last modified on

2017 Year 04 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024754


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name