UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comparison of delayed bleeding associated with endoscopic submucosal dissection for gastric neoplasms between solid and liquid diet
Title of the study (Brief title)	ESD Asahi Trial (EAT)
Region	Japan

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

Objectives
Narrative objectives1	the establishment of the way to ingest after ESD
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	delayed bleeding rate
Key secondary outcomes	1.the rate of ulcer scar about 4 weeks after ESD(evaluate by Sakita classification) 2.the QOL changing between the date of admission and leave the hospital(evaluate by EORTC QLQ-C30 and EORTC QLQ-STO 22) 3.hospital charges 4.abdominal distension 5.abdominal pain 6.constipation 7.diarrhea 8.nausea

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	solid diet
Interventions/Control_2	liquid diet
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 with gastric neoplasms who underwent ESD
Key exclusion criteria	(1)patients with use of antiplatelet agents(aspirin, thienopyridine derivative,and cilostazol) and anticoagulants (2) patients who are pregnant or nursing (3) patients with unstable mental condition (4) patients with use of steroid drugs (5) patients with bacterial and fungal infection (6) patients who are diagnosed as unsuitable for this trial by investigator
Target sample size	100

Research contact person
Name of lead principal investigator	Akihiro Miyakawa
Organization	Asahi General Hospital
Division name	Department of Gastroenterology
Address	1326, I, Asahi ,Chiba, Japan
TEL	0479-63-8111
Email	a292miyaka2007@yahoo.co.jp

Public contact
Name of contact person	Akihiro Miyakawa
Organization	Asahi General Hospital
Division name	Department of Gastroenterology
Address	1326, I, Asahi ,Chiba, Japan
TEL	0479-63-8111
Homepage URL
Email	a292miyaka2007@yahoo.co.jp

Sponsor
Institute	Department of Gastroenterology, Asahi General Hospital
Institute
Department

Funding Source
Organization	Asahi General 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	2014 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 29 Day
Anticipated trial start date	2014 Year 02 Month 12 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	Published
URL releasing results	https://www.karger.com/Article/FullText/494490
Results
Other related information

Management information
Registered date	2014 Year 02 Month 27 Day
Last modified on	2018 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015444