UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of risk factors of bleeding after endoscopic surgery and evaluation of perioperative safety for users of anticoagulants
Acronym	Management of the anticoagulant in endoscopic surgery
Scientific Title	Analysis of risk factors of bleeding after endoscopic surgery and evaluation of perioperative safety for users of anticoagulants
Scientific Title:Acronym	Management of the anticoagulant in endoscopic surgery
Region	Japan

Condition
Condition	gastric cancer, esophageal cancer, colon polyp, colon cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze risk factors of bleeding after endoscopic surgery and to evaluate validity and safety of perioperative discontinuation of anticoagulants
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bleeding rates and risk factors for bleeding after endoscopic surgery
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Users of anticoagulants who receive endoscopic surgery
Key exclusion criteria	Patients who are not adequate to study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shoko Ono
Organization	Hokkaido University Hospital
Division name	Divison of Endoscopy
Zip code
Address	Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
TEL	0117161161
Email	onosho@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shoko Ono
Organization	Hokkaido University Hospital
Division name	Divison of Endoscopy
Zip code
Address	Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
TEL	0117161161
Homepage URL
Email	onosho@med.hokudai.ac.jp

Sponsor
Institute	Department of Gastroenterology, Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	北海道大学病院（北海道）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 09 Day
Date of IRB	2016 Year 08 Month 09 Day
Anticipated trial start date	2016 Year 08 Month 09 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry	2019 Year 01 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 06 Month 30 Day

Other
Other related information	To evaluate bleeding and embolic events after endoscopic surgery for one month.

Management information
Registered date	2016 Year 08 Month 16 Day
Last modified on	2020 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027006