UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030747 |
|---|---|
| Receipt number | 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 | 2021/02/02 18:17:43 |
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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 | Kiyohiko |
| Middle name | |
| Last name | Shuto |
Organization
Teikyo University Chiba Medical Center
Division name
Department of Surgery
Zip code
299-0111
Address
3426-3 Anesaki, Ichihara, Chiba, Japan
TEL
0436-62-1211
kshuto@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiyohiko |
| Middle name | |
| Last name | Shuto |
Organization
Teikyo University Chiba Medical Center
Division name
Department of Surgery
Zip code
299-0111
Address
3426-3 Anesaki, Ichihara, Chiba, Japan
TEL
0436-62-1211
Homepage URL
kshuto@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
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
Teikyo University
Address
2-11-1 Kaga Itabashi-ku Tokyo
Tel
03-3964-7256
turb-office@teikyo-u.ac.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
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
| 2015 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2030 | 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
| 2018 | Year | 01 | Month | 10 | Day |
Last modified on
| 2021 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034898
