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Recruitment status
Unique ID issued by UMIN UMIN000021575
Receipt No. 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

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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
Institute Gunma University Hospital
Institute
Department

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
URL(English) https://upload.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


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