UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory research on pharmacological predictors for postoperative bleeding after colon polyp resection in patients taking direct-acting oral anticoagulants
Acronym	Exploratory research on pharmacological predictors for postoperative bleeding after colon polyp resection in patients taking DOAC
Scientific Title	Exploratory research on pharmacological predictors for postoperative bleeding after colon polyp resection in patients taking direct-acting oral anticoagulants
Scientific Title:Acronym	Exploratory research on pharmacological predictors for postoperative bleeding after colon polyp resection in patients taking DOAC
Region	Japan

Condition
Condition	colon polyp
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The incidence of postoperative gastrointestinal bleeding when colon polypectomy is performed on patients taking DOAC in accordance with Gastrointestinal Endoscopy Practice Guidelines supplement for patients taking antithrombotic drugs is expected to be approximately 10%. The risk of bleeding is approximately 10 times greater than in patients not taking DOAC. There are as yet no indicators established for monitoring the efficacy of DOAC, so uniform support is provided for all respective patients, but individualized treatment is provided for patients in the high-risk group when predictive markers that may cause gastrointestinal bleeding are identified, which can contribute to prevention of gastrointestinal bleeding. The aim of this study was to clarify predictive markers that may enable extraction of high-risk groups at risk of postoperative gastrointestinal bleeding, among patients taking DOAC who have undergone an endoscopic colon resection in accordance with the Gastrointestinal Endoscopy Practice Guidelines (supplement 2017) for patients taking antithrombotic drugs
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The effect of DOAC trough drug blood concentration (p-Xa activity) on postoperative gastrointestinal bleeding after colon polyp resection in patients taking DOAC
Key secondary outcomes	(1) The effect of DOAC (Tmax) drug blood concentration (PXa activity) on postoperative bleeding after colon polyp resection in patients taking DOAC. (2)The effect of polymorphism of drug-metabolizing enzymes on postoperative bleeding after colon polyp resection. (3) Effect of blood coagulation markers on postoperative bleeding after colon polyp resection. (4) Extraction of endoscopic characteristics of colon polyps for postoperative bleeding after colon polyp resection. (5) Extraction of pathological characteristics of colon polyps for postoperative bleeding after colon polyp resection. (6) Correlation of CHADs score on postoperative bleeding after colon polyp resection.

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. Patients aged 20 or older at the date of registration (date consent is obtained) with continuous administration of oral DOAC, who have undergone a colon polyp resection and who have consented to participate in this study. 2. PS: Patients with a performance status of 0 or 1 based on ECOG criteria.
Key exclusion criteria	1. Patients who have not consented to participate in this study. 2. Patients taking 3 or more antithrombotic drugs. 3. Patients with serious complications (heart failure, kidney failure, liver failure, respiratory failure). 4. Patients who are pregnant or breastfeeding. 5. Other patients determined to be unsuitable as clinical study subjects by the principal (sub) investigator.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Mutsushige Middle name Last name Mitsushige
Organization	Tokyo Medical University Hospital
Division name	Department of Gastroenterological Endoscopy
Zip code	160-8402
Address	6-1-1 Shinjuku, Shinjuku-ku,Tokyo
TEL	03-3351-6141
Email	mura05310531@gmail.com

Public contact
Name of contact person	1st name Masaki Middle name Last name Masaki
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Gastroenterology
Zip code	612-8555
Address	1-1 Mukouhata-cho, Fukakusa, Fushimi-ku, Kyoto
TEL	0756419161
Homepage URL
Email	ds110674@outlook.jp

Sponsor
Institute	Department of Gastroenterological Endoscopy, Tokyo Medical University Hospital
Institute
Department

Funding Source
Organization	no organization.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Medical University Hospital
Address	6-1-1 Shinjuku, Shinjuku-ku,Tokyo
Tel	03-3351-6141
Email	mura05310531@gmail.com

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	2020 Year 11 Month 27 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	Open public recruiting
Date of protocol fixation	2020 Year 04 Month 01 Day
Date of IRB	2020 Year 04 Month 30 Day
Anticipated trial start date	2020 Year 05 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This research is a continuation of the previous research (UMIN000032017) conducted at Shiga University of Medical Science.

Management information
Registered date	2020 Year 11 Month 27 Day
Last modified on	2020 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048597

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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