UMIN-CTR Clinical Trial

Basic information
Public title	ABO blood group is an independent risk factor for delayed post-procedural bleeding after colorectal endoscopic resection: a multi-center case-control study
Acronym	ABO blood group is an independent risk factor for delayed bleeding after colorectal endoscopic resection
Scientific Title	ABO blood group is an independent risk factor for delayed post-procedural bleeding after colorectal endoscopic resection: a multi-center case-control study
Scientific Title:Acronym	ABO Blood group is an independent risk factor for delayed bleeding after colorectal endoscopic resection
Region	Japan

Condition
Condition	Colorectal tumors
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to investigate whether O blood group is an independent risk factor for delayed post-procedural bleeding after colorectal endoscopic resection
Basic objectives2	Others
Basic objectives -Others	To confirm clinical impact
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of delayed post-procedural bleeding within 28 days from the procedure.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Consecutive patients who admitted to 4 hospitals to undergo endoscopic resection during the study period
Key exclusion criteria	1) patients who have never undergone blood group screening in each hospital or whose ABO blood group was undetermined despite the screening test 2) patients who underwent endoscopic resection without interrupting anti-platelets or anti-coagulants. For patients who met the eligibility criteria,
Target sample size	8625

Research contact person
Name of lead principal investigator	1st name Kazuki Middle name Last name Sumiyama
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Zip code	1058471
Address	3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan
TEL	03-3433-1111
Email	kaz_sum@jikei.ac.jp

Public contact
Name of contact person	1st name Hiroto Middle name Last name Furuhashi
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Zip code	1058471
Address	3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan
TEL	03-3433-1111
Homepage URL
Email	ms04furuhashi@gmail.com

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	The Jikei University School of Medicine
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	Institutional Review Board of The Jikei University School of Medicine
Address	3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan
Tel	03-3433-1111
Email	rinri@jikei.ac.jp

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	2019 Year 04 Month 13 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	2018 Year 12 Month 12 Day
Date of IRB	2019 Year 01 Month 15 Day
Anticipated trial start date	2019 Year 04 Month 13 Day
Last follow-up date	2019 Year 04 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We extracted cases who underwent endoscopic resection for colorectal tumors between January 2014 and December 2017 using endoscopy database (Solemio ENDO, Olympus medical systems Co., Tokyo, Japan; NEXUS, Fujifilm Co., Tokyo, Japan) and reviewed those medical records in four hospitals (The Jikei University Hospital, Tokyo, Japan; Katsushika medical center, Tokyo, Japan; The Jikei University Daisan Hospital, Tokyo, Japan; and The Jikei University Kashiwa Hospital, Chiba, Japan).

Management information
Registered date	2019 Year 04 Month 12 Day
Last modified on	2019 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041572