UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety evaluation of endoscopic therapy against patients receiving anticoagulants agents.
Title of the study (Brief title)	The safety evaluation of endoscopic therapy during anticoagulants therapy.
Region	Japan

Condition
Condition	Patients undergoing gastrointestinal endoscopic therapy during anticoagulant therapy
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is aimed to evaluate safety of endoscopic therapy in gastrointestinal tract for patients receiving anticoagulatns without cessation.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gastrointestinal bleeding during two weeks after endoscopic therapy.
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	Prevention
Type of intervention	Maneuver
Interventions/Control_1	endoscopic therapy
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	(A)Medical need of gastrointestinal endoscopic therapy. (B)Receiving anticoagulants agents. (C)Informed consent.
Key exclusion criteria	(A)INR exceeding the upper limit shown in the guideline by Japanese circulation society. (B)The patient who takes other antiplatelet agents
Target sample size	100

Research contact person
Name of lead principal investigator	Kazuhide Higuchi
Organization	Osaka Medical College
Division name	Second department of internal medicine
Address	2-7,Daigaku-machi,Takatukishi,Osaka
TEL	0726831221
Email	higuchi@osaka-med.ac.jp

Public contact
Name of contact person	kazuki Kakimoto
Organization	Osaka Medical College
Division name	Second department of internal medicine
Address	2-7,Daigaku-machi,Takatukishi,Osaka
TEL	0726831221
Homepage URL
Email	kazuki1977924@yahoo.co.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College
Organization
Division
Category of Funding Organization	Other
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	2016 Year 12 Month 06 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 12 Month 01 Day
Anticipated trial start date	2017 Year 01 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

Management information
Registered date	2016 Year 12 Month 06 Day
Last modified on	2018 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028946