UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044710 |
|---|---|
| Receipt number | R000050908 |
| Scientific Title | Comparison of the usefulness of INVOS and ICG fluorescence method as a method for evaluating residual intestinal blood flow during gastrointestinal resection surgery |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2023/01/06 10:35:54 |
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Basic information
Public title
Comparison of the usefulness of INVOS during intestinal resection surgery and blood flow evaluation by ICG fluorescence method.
Acronym
Comparison of blood flow evaluation by INVOS and ICG fluorescence method at the time of intestinal resection
Scientific Title
Comparison of the usefulness of INVOS and ICG fluorescence method as a method for evaluating residual intestinal blood flow during gastrointestinal resection surgery
Scientific Title:Acronym
Comparison of the usefulness of INVOS and ICG fluorescence method as a method for evaluating residual intestinal blood flow during gastrointestinal resection surgery
Region
| Japan |
Condition
Condition
esophageal and gastrointestinal and colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To measure oxygen saturation using INVOS in the intestine to be resected and in the remaining intestine in patients undergoing gastrointestinal resection and to evaluate whether it can be used as an indirect index of blood flow assessment, and to evaluate blood flow assessment at the same site using ICG fluorescence and to evaluate the correlation with blood flow assessment by INVOS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
INVOS oxygen saturation of residual intestine
Key secondary outcomes
Evaluation of correlation between INVOS tissue saturation and ICG fluorescence method, ICG fluorescence intensity, oxygen saturation, oxygen partial pressure, blood oxygen content, oxygen supply, oxygen consumption, oxygen uptake rate
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
| Maneuver |
Interventions/Control_1
INVOS measurement, ICG fluorescence method measurement
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
Patients scheduled for gastrointestinal resection at our hospital
Key exclusion criteria
Patients under 20 years old
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Egi |
Organization
Ehime University
Division name
Gastrointestinal Surgery and Surgical oncology
Zip code
791-0295
Address
454 Shitsukawa, Toon City, Ehime
TEL
0899605975
egi.hiroyuki.if@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Ogi |
Organization
Ehime University
Division name
Gastrointestinal Surgery and Surgical oncology
Zip code
791-0295
Address
454 Shitsukawa, Toon City, Ehime
TEL
0899605975
Homepage URL
ogi.yusuke.xx@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Ehime 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
Institutional Review Board,Ehime University Hospital
Address
Shitsukawa, Toon City, Ehime
Tel
089-960-5172
rinri@m.ehime-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 30 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2021 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050908
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| Registered date | File name |
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