An exploratory study of pharmacological predictors of postoperative bleeding after endoscopic papillary sphincterotomy in patients taking direct-acting oral anticoagulants

An exploratory study of pharmacological predictors of postoperative bleeding after endoscopic papillary sphincterotomy in patients taking direct-acting oral anticoagulants - FXa activity in post-EST bleeding in DOAC users

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056265

Enrollment

100

Registered

2024-11-25

Start date

2021-01-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary and pancreatic diseases

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The effect of DOAC trough drug blood level and FXa activity in post-EST bleeding in patients taking DOAC	—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Countries

Japan

Contacts

Public ContactMitsushige Sugimoto

Oita University Research Center for GLOBAL and LOCAL Infectious Disease

sugimo@oita-u.ac.jp097-586-5401

Outcome results