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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030747
Receipt No. R000034898
Scientific Title Evaluation of new clinical application to tissue perfusion of digestive surgery using indocyanine green (ICG) enhanced fluorescence system
Date of disclosure of the study information 2018/01/11
Last modified on 2018/01/10

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Basic information
Public title Evaluation of new clinical application to tissue perfusion of digestive surgery using indocyanine green (ICG) enhanced fluorescence system
Acronym Evaluation of new clinical application to tissue perfusion of digestive surgery using indocyanine green (ICG) enhanced fluorescence system
Scientific Title Evaluation of new clinical application to tissue perfusion of digestive surgery using indocyanine green (ICG) enhanced fluorescence system
Scientific Title:Acronym Evaluation of new clinical application to tissue perfusion of digestive surgery using indocyanine green (ICG) enhanced fluorescence system
Region
Japan

Condition
Condition Digestive disease
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Our purpose is to evaluate clinical benefit and safety to investigate anastomotic tissue perfusion in reconstruction using ICG-enhanced fluorescence system
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Safety of the measurement of blood supply in anastomotic tissue using ICG-enhanced fluorescence system: incidence rate of intraoperative or postoperative complication related to ICG injection.
Key secondary outcomes Clinical outcomes: incidence rate of postoperative complication, severity assessment of postoperative complication by Clavien-Dindo classification system, and postoperative hospital stay, mortality.

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 Device,equipment
Interventions/Control_1 To investigate blood supply of gastrointestinal tract tissue, ICG intravenous injection during operation was performed using ICG solution at a concentration of 5 mg/ml. Anostomoses were observed for five minutes. In all cases, laparoscopic system (IMAGE 1 SPIESTM, KARL STORZ GmbH & Co. KG, Tuttlingen, Germany) was used to generate ICG-enhanced fluorescence images.
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 Inclusion criteria are as follow: 20 and more than 20 years old, undergoing digestive surgery operation, and requiring to provide written informed concent before enrolment.
Key exclusion criteria Exclusion criteria are as follow: having an allergy to ICG or iodine, pregnant or breastfeeding woman, being concidered as ineligible, and retraction of the concent.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikito Mori
Organization Teikyo University Chiba Medical Center
Division name Department of Surgery
Zip code
Address 3426-3 Anesaki, Ichihara, Chiba, Japan
TEL 0436-62-1211
Email m-mori@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mikito Mori
Organization Teikyo University Chiba Medical Center
Division name Department of Surgery
Zip code
Address 3426-3 Anesaki, Ichihara, Chiba, Japan
TEL 0436-62-1211
Homepage URL
Email m-mori@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization Teikyo 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 帝京大学ちば総合医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 11 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 Open public recruiting
Date of protocol fixation
2015 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 18 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
2018 Year 01 Month 10 Day
Last modified on
2018 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034898

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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