UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Accuracy of pathological diagnosis of frozen section in gastric ESD
Title of the study (Brief title)	Accuracy of pathological diagnosis of frozen section in gastric ESD
Region	Japan

Condition
Condition	Early gastric cancer or gastric adenoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate accuracy of pathological diagnosis of frozen section as a fundamental study on rapid biopsy during gastric ESD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accuracy of pathological diagnosis of frozen section in resected specimen of gastric ESD(positive predictive value, negative predictive value, sensitivity, specificity)
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	1. Patients who can consent in writing for participation in this study 2. Patients who receive treatment with ESD and whose pathological specimens can be created
Key exclusion criteria	1. Patients who are interrupted treatment with ESD for some reason 2. Patients who are judged inappropriate for this study by the doctor
Target sample size	200

Research contact person
Name of lead principal investigator	Tomoki Inaba
Organization	Kagawa Prefectural Central Hospital
Division name	Gastroenterology
Address	1-2-1 Asahi-machi, Takamatsu-city, Kagawa, Japan
TEL	087-811-3333
Email	t-inaba@chp-kagawa.jp

Public contact
Name of contact person	Shigenao Ishikawa
Organization	Kagawa Prefectural Central Hospital
Division name	Gastroenterology
Address	1-2-1 Asahi-machi, Takamatsu-city, Kagawa, Japan
TEL	087-811-3333
Homepage URL
Email	ishikawa5308@yahoo.co.jp

Sponsor
Institute	Kagawa Prefectural Central Hospital
Institute
Department

Funding Source
Organization	Kagawa Prefectural Central Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	2019 Year 01 Month 28 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 01 Month 15 Day
Anticipated trial start date	2019 Year 01 Month 28 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	Not applicable

Management information
Registered date	2019 Year 01 Month 23 Day
Last modified on	2019 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040409