UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharmacological risk factor for gastrointestinal bleeding after endoscopic submucosal dissection in gastric cancer patients with direct oral anticoagulants
Title of the study (Brief title)	Pharmacological risk factor for bleeding after ESD in patients with DOAC
Region	Japan

Condition
Condition	Early-stage gastric cancer patients treated with DOAC
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To clarify a risk factor for bleeding after ESD for early-stage gastric cancer in patients treated with DOAC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association with plasma concentration of DOAC at trough or anti-Xa activity and incidence of bleeding after ESD for early-stage gastric cancer in patients treated with DOAC
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. With consent 2. Performance status: ECOG 0 or 1 3. Early stage gastric cancer according to the treatment guideline for gastric cancer by the Japanese association of gastric cancer. 4. Over 20 years old patients treated with DOAC
Key exclusion criteria	1. No consent 2. with three kinds of anticoagulants 3. with severe diseases (heart, liver and pulmonary failure) 4. Pregnancy
Target sample size	400

Research contact person
Name of lead principal investigator	Mitsushige Sugimoto
Organization	Shiga University of Medical Science Hospital
Division name	Division of Digestive Endoscopy
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN, 520-2192
TEL	077-548-2618
Email	sugimo@belle.shiga-med.ac.jp

Public contact
Name of contact person	Mitsushige Sugimoto
Organization	Shiga University of Medical Science Hospital
Division name	Division of Digestive Endoscopy
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN, 520-2192
TEL	077-548-2618
Homepage URL
Email	sugimo@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science Hospital
Institute
Department

Funding Source
Organization	Shiga University of Medical Science 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	2018 Year 03 Month 28 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 27 Day
Anticipated trial start date	2018 Year 03 Month 27 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	None

Management information
Registered date	2018 Year 03 Month 27 Day
Last modified on	2018 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036457