UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Takanori Sakaguchi
Organization	Hamamatsu University School of Medicine
Division name	Second Department of Surgery
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	Takanori Sakaguchi
Organization	Hamamatsu University School of Medicine
Division name	Second Department of Surgery
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2017 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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