UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observation of the upper gastrointestinal tract lesions by epinephrine spraying
Title of the study (Brief title)	Observation of lesions by epinephrine spraying
Region	Japan

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

Objectives
Narrative objectives1	Consider the endoscopic image of the change by vasoactive substances in esophageal/ gastric mucosa or vessel in mucosa
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Contribution to diagnoses of extent and depth of cancer lesions
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	Diagnosis
Type of intervention	Other
Interventions/Control_1	At upper gastrointestinal endoscopy examination,in addition to the standard diagoses, epinephrine spraying is performed
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 with the upper gastrointestinal tract lesions will be enforced the treatment (surgery or endoscopic therapy)
Key exclusion criteria	The patients who are allergic to epinephrine Other, patients judged to be inappropriate
Target sample size	50

Research contact person
Name of lead principal investigator	Kawakubo Hirofumi
Organization	Keio University,School of Medicine
Division name	Surgery
Address	Shinanomachi 35,Shinjyuku-ku,Tokyo
TEL	03-3353-1211
Email	hkawakubo@z3.keio.jp

Public contact
Name of contact person	Rieko Nakamura
Organization	Keio University,School of Medicine
Division name	Surgery
Address	Shinanomachi 35,Shinjyuku-ku,Tokyo
TEL	03-3353-1211
Homepage URL
Email	rieko-na@cam.hi-ho.ne.jp

Sponsor
Institute	Keio University,School of Medicine
Institute
Department

Funding Source
Organization	Keio 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	2015 Year 05 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 15 Day
Anticipated trial start date	2014 Year 11 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	2015 Year 05 Month 28 Day
Last modified on	2018 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018175