UMIN-CTR Clinical Trial

Basic information
Public title	Indocyanine Green (ICG) Fluorescence Angiography for Quantitative Evaluation of Viability of Esophageal Substitute in Patients Undergoing Esophagectomy
Acronym	ICG Fluorescence Angiography for Evaluation of Viability of Esophageal Substitute
Scientific Title	Indocyanine Green (ICG) Fluorescence Angiography for Quantitative Evaluation of Viability of Esophageal Substitute in Patients Undergoing Esophagectomy
Scientific Title:Acronym	ICG Fluorescence Angiography for Evaluation of Viability of Esophageal Substitute
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Quantitative assessment of blood flow with ICG fluorescence imaging to evaluate viability of esophageal substitute
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	luminance assessed by ICG angiography, rate of anastomotic leakage
Key secondary outcomes	in-hospital days, kinds of complications, duration of complication healing

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) patients undergoing esophageal reconstruction 2) patients who understand purpose of study and reveive informed consent 3) patents with 20 years old or older
Key exclusion criteria	1) patients who have allergy to ICG 2) patients who are judged to be ineligible for subject by researcher
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yoshihiko Maehara
Organization	Kyushu University
Division name	Department of Surgery and Science
Zip code
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5466
Email	maehara@surg2.med.kyushu-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hiroshi Saeki
Organization	Kyushu University
Division name	Department of Surgery and Science
Zip code
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5466
Homepage URL
Email	h-saeki@surg2.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	Department of Surgery and Science, Kyushu University
Organization
Division
Category of Funding Organization	Other
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	2015 Year 05 Month 09 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	Completed
Date of protocol fixation	2013 Year 07 Month 09 Day
Date of IRB	2013 Year 07 Month 09 Day
Anticipated trial start date	2013 Year 07 Month 09 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective study

Management information
Registered date	2015 Year 05 Month 09 Day
Last modified on	2019 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020256