UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective multicenter study 2 of the effectiveness of NBI magnified endoscopy with acetic acid for the diagnosis of histological type of early gastric cancer.
Title of the study (Brief title)	Acetic acid NBI study 2
Region	Japan

Condition
Condition	early gastric cancer, depressed type
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the accuracy of white light endoscopy, NBI magnified endoscopy and acetic acid NBI magnified endoscopy for the diagnosis of mixture of moderate or poorly differentiated of gastric adenocarcinoma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accuracy rate of the diagnosis of histological type (White light endoscopy, NBI magnified endoscopy vs. acetic acid NBI magnified endoscopy)
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	The patients who have an early gastric cancer treated by ESD (endoscopic submucosal dissection)
Key exclusion criteria	1. The patients who rejected informed consent. 2. The patients who were treated by chemotherapy or radiation therapy. 3. The patients without tolerability for prolonged sedation. 4. The diameter of lesion is more over 4cm in size.
Target sample size	70

Research contact person
Name of lead principal investigator	OYAMA TSUNEO
Organization	Saku Central Hospital
Division name	Gastroenterology
Address	197 Usuda, Saku-city, Nagano.
TEL	0267827171
Email	kishinotakaaki@hotmail.co.jp

Public contact
Name of contact person	KISHINO TAKAAKI
Organization	Saku Central Hospital
Division name	Gastroenterology
Address	197 Usuda, Saku-city, Nagano.
TEL	0267827171
Homepage URL
Email	kishinotakaaki@hotmail.co.jp

Sponsor
Institute	Saku Central Hospital
Institute
Department

Funding Source
Organization	Saku Central Hospital
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	2012 Year 03 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 02 Month 02 Day
Anticipated trial start date	2012 Year 03 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	We are waiting for the judgement of IRB.

Management information
Registered date	2012 Year 02 Month 29 Day
Last modified on	2017 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008732