UMIN-CTR Clinical Trial

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

Condition
Condition	Biliary disease
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The incidence of postoperative gastrointestinal bleeding when EST is performed on patients taking DOAC in accordance with Gastrointestinal Endoscopy Practice Guidelines supplement for patients taking antithrombotic drugs is expected to be approximately 8-10%. 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 EST 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	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	The effect of DOAC trough drug blood concentration (p-Xa activity) on postoperative gastrointestinal bleeding after EST for common bile duct stone or cancer in patients taking DOAC
Key secondary outcomes	(1) The effect of polymorphism of drug-metabolizing enzymes on postoperative bleeding after EST in patients taking DOAC. (2) The effect of blood coagulation markers on postoperative bleeding after EST in patients taking DOAC. (3) Extraction of characteristics of endoscopic treatment-related factors for postoperative bleeding after EST in patients taking DOAC. (4) Differences between DOAC types for postoperative bleeding after EST in patients taking DOAC. (5) Correlation of CHADs score on postoperative bleeding after EST in patients taking DOAC.

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. Those who are 20 years old or older on the registration date (consent acquisition date) 2. Those who are taking DOAC who will undergo endoscopic sphincteropapillotomy for common bile duct stones and cancer in accordance with guidelines. 3. Those who have given their consent to participate in this research by signing the consent form.
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	100

Research contact person
Name of lead principal investigator	1st name Mitsushige Middle name Last name Sugimoto
Organization	Tokyo Medical University
Division name	Department of Gastroenterological Endoscopy
Zip code	1600023
Address	6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL	0333426111
Email	sugimo@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Toshihiro Middle name Last name Homma
Organization	Tokyo Medical University
Division name	Department of Gastroenterology and Hepatology
Zip code	1600023
Address	6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL	0333426111
Homepage URL
Email	t-homma@tokyo-med.ac.jp

Sponsor
Institute	Tokyo Mediclal University
Institute
Department

Funding Source
Organization	no organization.
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	Department of Gastroenterology and Hepatology, Tokyo Medical University Hospital
Address	6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
Tel	0333426111
Email	t-homma@tokyo-med.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	2021 Year 02 Month 08 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 07 Month 21 Day
Date of IRB	2020 Year 12 Month 25 Day
Anticipated trial start date	2021 Year 01 Month 04 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	None

Management information
Registered date	2021 Year 02 Month 07 Day
Last modified on	2021 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048239