Observational study on the safety and usefulness of a novel hemostatic agent for endoscopic sphincterotomy

Observational study on the safety and usefulness of a novel hemostatic agent for endoscopic sphincterotomy - Observational study on the safety and usefulness of a novel hemostatic agent for endoscopic sphincterotomy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051301

Enrollment

300

Registered

2023-06-12

Start date

2023-06-12

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

obstructive jaundice

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria 1. Patients who require biliary drainage for treatment of common bile duct stones, cholangitis, and obstructive jaundice, etc. based on various diagnostic imaging studies. 2. Patients must be at least 20 years old and have good ADL (ECOG performance status 0-1). 3. 3. Informed consent in the study has been obtained from the patient or the patient's surrogate

Exclusion criteria

Exclusion criteria: Patients with any of the following conditions will not be included in this study 1. Patients with a history of endoscopic sphincterotomy or endoscopic papillectomy 2. Patients with duodenal stenosis. 3. Patients who are scheduled for endoscopic papillectomy 4. Patients deemed inappropriate for the study by the investigator.

Design outcomes

Primary

Measure	Time frame
Rate of post EST bleeding	—

Countries

Japan

Contacts

Public ContactYusuke Ishida

Fukuoka University, Faculty of Medicine Department of Gastroenterology and Medicine

y.ishida.cb@fukuoka-u.ac.jp+81-92-801-1011

Outcome results