UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056265 |
|---|---|
| Receipt number | R000064282 |
| Scientific Title | An exploratory study of pharmacological predictors of postoperative bleeding after endoscopic papillary sphincterotomy in patients taking direct-acting oral anticoagulants |
| Date of disclosure of the study information | 2024/11/25 |
| Last modified on | 2024/11/25 14:43:46 |
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Basic information
Public title
An exploratory study of pharmacological predictors of postoperative bleeding after endoscopic papillary sphincterotomy in patients taking direct-acting oral anticoagulants
Acronym
FXa activity in post-EST bleeding in DOAC users
Scientific Title
An exploratory study of pharmacological predictors of postoperative bleeding after endoscopic papillary sphincterotomy in patients taking direct-acting oral anticoagulants
Scientific Title:Acronym
FXa activity in post-EST bleeding in DOAC users
Region
| Japan |
Condition
Condition
Biliary and pancreatic diseases
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify predictive markers to identify high-risk groups for postoperative gastrointestinal bleeding among patients taking DOACs who are scheduled to undergo EST for common bile duct stones or cancer according to the Guidelines for Gastrointestinal Endoscopy in Patients Taking Antithrombotic Medications (Supplement 2017).
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The effect of DOAC trough drug blood level and FXa activity in post-EST bleeding in patients taking DOAC
Key secondary outcomes
(1) Influence of drug-metabolizing enzyme gene polymorphisms on gastrointestinal bleeding after EST in patients taking DOACs
(2) The influence of blood coagulation markers on gastrointestinal bleeding after EST in patients taking DOACs
(3) Extracting the characteristics of factors related to endoscopic treatment in gastrointestinal bleeding after EST in patients taking DOACs
(4) Differences in DOACs in gastrointestinal bleeding after EST in patients taking DOACs
(5) The relevance of CHADs scores in gastrointestinal bleeding after EST in patients taking DOACs
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 aged 20 years or older
2. Those taking DOACs who are scheduled to undergo endoscopic papillary sphincterotomy for choledocholithiasis or cancer in accordance with the guidelines for the diagnosis and treatment of patients with antithrombotic drugs (2017 supplement)
3. Those who have given their consent to participate in this study by signing the consent form
Key exclusion criteria
1. Those who did not give consent to participate in this study
2. Those who are taking three or more types of antithrombotic drugs
3. Those who have serious complications (heart failure, renal failure, hepatic failure, respiratory failure)
4. Those who are pregnant or breastfeeding
5. Those who are judged to be unsuitable for participation in this study for other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mitsushige |
| Middle name | |
| Last name | Sugimoto |
Organization
Oita University
Division name
Research Center for GLOBAL and LOCAL Infectious Disease,
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama, Yufu, Oita
TEL
097-586-5401
sugimo@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsushige |
| Middle name | |
| Last name | Sugimoto |
Organization
Oita University
Division name
Research Center for GLOBAL and LOCAL Infectious Disease
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama, Yufu
TEL
097-586-5401
Homepage URL
sugimo@oita-u.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
No fund
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-ku Shinjuku, Tokyo, JAPAN
Tel
03-3342-6111
ds110674@outlook.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
東京医科大学 消化器内科 准教授 土屋 貴愛
宮崎大学 消化器内科 教授 河上 洋
京都医療センター 消化器内科 村田 雅樹
東京医科大学 八王子医療センター 消化器内科 准教授 北村 勝哉
手稲渓仁会病院 消化器病センター 主任医長 金 俊文
仙台市医療センター 仙台オープン病院 消化器内科 副部長 菅野 良秀
東京大学 消化器内科 助教 木暮 宏史
山梨大学 消化器内科 特任講師 深澤 光晴
近畿大学 消化器内科 講師 竹中 完
岡山大学 消化器内科 講師 加藤 博也
湘南鎌倉総合病院 消化器内科 主任部長 小泉 一也
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 25 | 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
| 2021 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation/examination items
1. Clinical data: age, gender, medical history, family history, medication history, alcohol consumption history, smoking history, height, weight, dialysis history
2. Presence or absence of direct oral anticoagulant medication: non-valvular atrial fibrillation, pulmonary thromboembolism, the following off-label diseases
3. Chest X-ray: CTR (%), electrocardiogram
4. General blood test data: degree of anemia, liver function (GOT, GPT, GGTP, LDH, T-Bil), renal function (BUN, Cre), HbA1c
5. Blood clotting markers: PT, APTT, FIB, D-dimmer
6. Resection information
7. Occurrence of adverse events (gastrointestinal hemorrhage, gastrointestinal perforation, pancreatitis, cholangitis, etc., and how they were dealt with) Severity was assessed using the Cotton et al. classification of the severity of complications of ERCP and EST
8. Presence or absence of post-procedure hemorrhage and hemostatic methods (severity assessment, degree of anemia progression, etc.)
9. Presence or absence of thromboembolism
10. DOAC drug blood concentration (anti-Xa activity)
11. Drug-metabolizing enzyme gene polymorphisms
12. CHADs score
13. Drug blood concentration and anti-Xa activity at trough
gene polymorphisms ABCB1 (1236C>T, 2677 G>T/A, 3435 C>T), ABCG2 (421C>A), CYP3A5 (*3)
Management information
Registered date
| 2024 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064282
