UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the intestinal blood flow using Indocyanine green(ICG)fluorescence method in abdominal emergency surgery
Acronym	Evaluation of the intestinal blood flow using Indocyanine green(ICG)fluorescence method in abdominal emergency surgery
Scientific Title	Evaluation of the intestinal blood flow using Indocyanine green(ICG)fluorescence method in abdominal emergency surgery
Scientific Title:Acronym	Evaluation of the intestinal blood flow using Indocyanine green(ICG)fluorescence method in abdominal emergency surgery
Region	Japan

Condition
Condition	Acute abdomen
Classification by specialty	Gastroenterology Surgery in general Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the blood flow in intestinal tract with ischemia using the ICG fluorescence method in abdominal emergency surgery
Basic objectives2	Others
Basic objectives -Others	Presence of postoperative morbidity
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Presence of ICG fluorescence in intestinal tract with ischemia
Key secondary outcomes	1 Presence of intestinal necrosis 2 Postoperative morbidity 3 Postoperative hospital stay

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	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Indocyanine green intravenous injection at the abdominal emergency surgery
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 Abdominal emergency surgery patient 2 Written informed consent
Key exclusion criteria	1 Allergic hypersensitivity of the indocyanine green 2 Cases of incapacity decided by attending physicians
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Ueda
Organization	Minami-Nara General Medical Center
Division name	Department of Surgery
Zip code	6388551
Address	8-1 Fukugami, Oyodo, Yoshino, Nara, Japan
TEL	0747-54-5000
Email	takeueda@naramed-u.ac.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Ueda
Organization	Minami-Nara General Medical Center
Division name	Department of Surgery
Zip code	6388551
Address	8-1 Fukugami, Oyodo, Yoshino, Nara, Japan
TEL	0747-54-5000
Homepage URL
Email	takeueda@naramed-u.ac.jp

Sponsor
Institute	Minami-Nara General Medical Center
Institute
Department

Funding Source
Organization	Minami-Nara General Medical Center
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	Minami-Nara General Medical Center
Address	8-1 Fukugami, Oyodo, Yoshino, Nara, Japan
Tel	0747-54-5000
Email	takeshiueda8@yahoo.co.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	南奈良総合医療センター(奈良県)

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 08 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	12
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	It is taking a long time to write results.
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	Enrolling by invitation
Date of protocol fixation	2017 Year 08 Month 14 Day
Date of IRB	2017 Year 09 Month 07 Day
Anticipated trial start date	2017 Year 09 Month 07 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 11 Month 08 Day
Last modified on	2022 Year 11 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034117