UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical validation of the gastrointestinal blood flow in the anastomotic part during laparoscopic esophagus/gastric cancer surgery
Title of the study (Brief title)	Validation of the gastrointestinal blood flow in the anastomotic part
Region	Japan

Condition
Condition	esophageal cancer and gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate for the usefulness and safety of ICG fluorescence method identifying intestinal blood flow.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of anastomotic leakage
Key secondary outcomes

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	Medicine
Interventions/Control_1	indocyanine green
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Initial esophageal cancer or gastric cancer case
Key exclusion criteria	1) Cases with severe ischemic heart disease 2) Cases with complications of liver cirrhosis and active hepatitis 3) Cases with dyspnea requiring oxygen administration 4) Cases in which dialysis is performed in chronic renal failure 5) Cases requiring complication of other organs 6) Other cases that the physician judged as inappropriate
Target sample size	50

Research contact person
Name of lead principal investigator	Takayuki Nobuoka
Organization	Sapporo Medical University
Division name	Department of Surgery, Surgical Oncology and Science
Address	South-1, West-16, Chuo-ku Sapporo, Japan
TEL	011-611-2111
Email	tnobu@sapmed.ac.jp

Public contact
Name of contact person	Takayuki Nobuoka
Organization	Sapporo Medical University
Division name	Department of Surgery, Surgical Oncology and Science
Address	South-1, West-16, Chuo-ku Sapporo, Japan
TEL	011-611-2111
Homepage URL
Email	tnobu@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University
Institute
Department

Funding Source
Organization	Sapporo Medical University
Organization
Division
Category of Funding Organization	Other
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	2018 Year 06 Month 21 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 03 Month 08 Day
Anticipated trial start date	2018 Year 03 Month 08 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	2018 Year 06 Month 21 Day
Last modified on	2018 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037728