Exploratory research on pharmacological predictors for postoperative bleeding after endoscopic sphincterotomy in patients taking direct-acting oral anticoagulants

Exploratory research on pharmacological predictors for postoperative bleeding after endoscopic sphincterotomy in patients taking direct-acting oral anticoagulants - Exploratory research on pharmacological predictors for postoperative bleeding after EST in patients taking DOAC

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043269

Enrollment

100

Registered

2021-02-08

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 disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
(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.	—

Measure

Time frame

(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.

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Countries

Japan

Contacts

Public ContactToshihiro Homma

Tokyo Medical University Department of Gastroenterology and Hepatology

t-homma@tokyo-med.ac.jp0333426111

Outcome results