UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative risk of gastrointestinal bleeding in patients with anticoagulants undergoing endoscopic treatment.
Title of the study (Brief title)	Comparative risk of gastrointestinal bleeding in patients with anticoagulants undergoing endoscopic treatment.
Region	Japan

Condition
Condition	early esophageal cancer/early gastric cancer/early colon cancer/gastric adenoma/colon polyp
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify as to wether endoscopic treatment with anticoagulants increase the risk of complications.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate the frequency of bleeding after treatment of endoscopy.
Key secondary outcomes	adverse event rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The safety of anticoaglants
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who take anticoagulation.
Key exclusion criteria	Patients ineligible for this study. Patients administer treatment of hepalinization. Without the consent of the patients.
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroto Miwa
Organization	Hyogo College of Medicine.
Division name	Gastroenterology
Address	1-1 Mucogawa cho Nishinomiya city Hyogo
TEL	0798-45-6662
Email	miwahgi@hyo-med.ac.jp

Public contact
Name of contact person	Yoshitaka Kitayama
Organization	Hyogo College of Medicine.
Division name	Gastroenterology
Address	1-1 Mucogawa cho Nishinomiya city Hyogo
TEL	0798-45-6662
Homepage URL
Email	yoshitaka591027@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine.
Institute
Department

Funding Source
Organization	none
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	2017 Year 08 Month 22 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 08 Month 22 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	2017 Year 08 Month 21 Day
Last modified on	2017 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032918