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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026663
Receipt No. R000030519
Scientific Title Evaluation of tissue blood flow for the digestive tract and the liver by finger-mounted tissue oximetry during peri-oerative period in patients undergoing gastroenterological and hepatobiliary surgery
Date of disclosure of the study information 2017/04/01
Last modified on 2017/03/23

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Basic information
Public title Evaluation of tissue blood flow for the digestive tract and the liver by finger-mounted tissue oximetry during peri-oerative period in patients undergoing gastroenterological and hepatobiliary surgery
Acronym Evaluation of gastrointestinal and hepatic blood flow by finger-mounted tissue oximetry.
Scientific Title Evaluation of tissue blood flow for the digestive tract and the liver by finger-mounted tissue oximetry during peri-oerative period in patients undergoing gastroenterological and hepatobiliary surgery
Scientific Title:Acronym Evaluation of gastrointestinal and hepatic blood flow by finger-mounted tissue oximetry.
Region
Japan

Condition
Condition Ptients who are going to undergo gastrointestinal (GI) surgery (for GI tract malignancies, inflammatory bowel disease, or bowel obstruction) or hepatectomy (for hepatobiliary malignancies)
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To obtain normal values of tissue blood flow (tissue oxygen saturation: rSO2, and total hemoblobin index: T-HbI) in each gastrointestinal tract and the liver.
Basic objectives2 Others
Basic objectives -Others To evaluate the relationship between postoperative leakage and bowel blood flow at anastomosed sites. In the case of hepatectomy, to evaluate the effects of hepatic hilar clamping (so-called Pringle's manuvae) on hepatic or intestinal blood flow
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The average values of tissue blood flow (tissue oxygen saturation: rSO2, and total hemoblobin index: T-HbI) in each gastrointestinal tract and the liver.
Key secondary outcomes postoperative anastomotic leakage

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 finger-mounted tissue oximetry
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 undergoing gastroenterological surgery or hepatectomy.
Key exclusion criteria 1) Patients who are assessed as not eligible for this study by the investigators
2)patients who do not consent
3) patients whose intestinal surface is damaged by adhesion
4) patients whose abdominal blood flow is unstable because of sepsis or bleeding
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanori Sakaguchi
Organization Hamamatsu University School of Medicine
Division name Second Department of Surgery
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL 053-435-2279
Email saka1119@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takanori Sakaguchi
Organization Hamamatsu University School of Medicine
Division name Second Department of Surgery
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL 053-435-2279
Homepage URL
Email saka1119@hama-med.ac.jp

Sponsor
Institute Second Department of Surgery, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Second Department of Surgery, Hamamatsu University School of Medicine
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 01 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
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 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
2017 Year 03 Month 23 Day
Last modified on
2017 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030519

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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