UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043269 |
|---|---|
| Receipt number | R000048239 |
| Scientific Title | Exploratory research on pharmacological predictors for postoperative bleeding after endoscopic sphincterotomy in patients taking direct-acting oral anticoagulants |
| Date of disclosure of the study information | 2021/02/08 |
| Last modified on | 2021/02/07 02:41:17 |
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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
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
t-homma@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Mediclal University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048239
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
