UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of safety of endoscopic submucosal dissection for gastric neoplasms without discontinuation of thienopyridine derivatives.
Title of the study (Brief title)	Gastric ESD on thienopyridines study.
Region	Japan

Condition
Condition	Gastric neoplasms
Classification by specialty	Gastroenterology Cardiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We aimed to evaluate safety of gastric ESD without discontinuation of thienopyridine derivatives.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Post operative bleeding rate
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Endoscopic submucosal dissection
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) Diagnosed as or suspicious of gastric adenoma/adenocarcinoma (cStageIA). 2) More than six months after last PCI. 3) An oral administration of clopidogrel or prasugrel. 4) A treatment for a single lesion. 5) Older than 19 years and younger than 85 years. 6) Performance status of 0-2. 7) Normal liver, renal, and hematological functions. 8) Follow-up of 60 days after treatment. 9) Written informed consent.
Key exclusion criteria	1) Double registration. 2) A past history of coronary stent embolism. 3) A stent located in left main coronary trunk. 4) A past history of irradiation in upper abdomen. 5) A plan of following treatment for esophageal or duodenal lesions. 6) A recent treatment for upper GI lesions within 28 days before registration. 7) A plan of following treatment for upper GI lesions within 28 days after treatment. 8) A systemic administration of steroids or anticoagulants. 9) An administration of NSAID or other antiplatelets that can be withdrawn before treatment. 10) Pregnancy or bleastfeeding. 11) An active bacterial or fungal infection. 12) A poor control of hypertension. 13) A severe respiratory disease. 14) Other conditions that are judged not suitable.
Target sample size	10

Research contact person
Name of lead principal investigator	Satoshi Ono
Organization	The University of Tokyo
Division name	Department of Gastroenterology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo.
TEL	03-3815-5411
Email	satoshi-tky@umin.ac.jp

Public contact
Name of contact person	Satoshi Ono
Organization	The University of Tokyo
Division name	Department of Gastroenterology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo.
TEL	03-3815-5411
Homepage URL
Email	satoshi-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 04 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 26 Day
Anticipated trial start date	2015 Year 04 Month 10 Day
Last follow-up date	2016 Year 11 Month 28 Day
Date of closure to data entry	2016 Year 11 Month 28 Day
Date trial data considered complete	2016 Year 11 Month 28 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 08 Day
Last modified on	2016 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019450