UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044710
Receipt No. 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 2021/06/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ogi.yusuke.xx@ehime-u.ac.jp

Sponsor
Institute Ehime University
Institute
Department

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
Email 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 Preinitiation
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
2021 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050908

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.