UMIN-CTR Clinical Trial

Basic information
Public title	An acetic acid-indigocarmine mixture for the detection of early gastric cancers
Acronym	An acetic acid-indigocarmine mixture for the detection of early gastric cancers
Scientific Title	An acetic acid-indigocarmine mixture for the detection of early gastric cancers
Scientific Title:Acronym	An acetic acid-indigocarmine mixture for the detection of early gastric cancers
Region	Japan

Condition
Condition	Patients examined by esophagogastroduodenoscopy
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the feasibility of an acetic acid-indigocarmine mixture for the detection of early gastric cancers
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of detection of early gastric cancers in according to pathological diagnosis ater 7 days of esophagogastroduodenoscopy and biopsy.
Key secondary outcomes	To evaluate these factors: age, smoking, mucosal atrophy, H. pylori infection, therapic history including endoscopic resection and gastrectomy of gastric cancer, tumor location and time of exmaination related to the detection of early gastric cancers by using an acetic acid-indigocarmine mixture

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	Prevention
Type of intervention	Medicine
Interventions/Control_1	After conventional esopgagogastroduodenoscopy, an acetic acid-indigocarmine mixture (1.5% acetic acid, 0.4% indigocarmine and a small amount of dimethicone) was sprinkled onto the gastric mucosa. Biopsy was taken from the unstained area and pathological diagnosis was examined.
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	Patients evaluated by esophagogastroduodenoscopy. Patients with written and oral informed consent are included.
Key exclusion criteria	Patients with severe complications are excluded.
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Hattori
Organization	Medical coroporation Yamashita Hospital
Division name	Gastroenterology
Zip code	4918531
Address	1-3-5, Nakamachi Ichnimomiya
TEL	0586-45-4511
Email	m.hattori@yamashita.or.jp

Public contact
Name of contact person	1st name Ippei Middle name Last name Matsuzaki
Organization	Medical coroporation Yamashita Hospital
Division name	Gastroenterology
Zip code	4918531
Address	1-3-5, Nakamachi Ichnimomiya
TEL	0586-45-4511
Homepage URL
Email	imatsu@med.nagoya-u.ac.jp

Sponsor
Institute	Medical coroporation Yamashita Hospital
Institute
Department

Funding Source
Organization	Medical coroporation Yamashita Hospital
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	Medical coroporation Yamashita Hospital
Address	1-3-5, Nakamachi Ichnimomiya
Tel	0586-45-4511
Email	y.okudaira@yamashita.or.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	医療法人　山下病院 Medical coroporation Yamashita Hospital

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 15 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	Completed
Date of protocol fixation	2016 Year 02 Month 12 Day
Date of IRB	2016 Year 01 Month 28 Day
Anticipated trial start date	2016 Year 02 Month 15 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 04 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 15 Day
Last modified on	2020 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024232