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GI endoscopy and anticoagulant therapy -a multicenter obsevational study-

GI endoscopy and anticoagulant therapy -a multicenter obsevational study- - Osaka GI-anticoagulant (GIANT) study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000009109
Enrollment
450
Registered
2012-10-15
Start date
2012-09-27
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

Patients who are treated with anticoagulant drugs requiring endoscopic biopsy or therapeutics

Interventions

None listed

Sponsors

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients taking warfarin or other antigocoagulant drugs (e.g., dabigatran). 2) Patients older than 20 years old. 3) Patients requiring endoscopic biopsy or treatment 4) Patients who gave written informed concent.

Exclusion criteria

Exclusion criteria: 1) Patients with unstable vital sign with high risk of endoscopy. 2) Patients with apparent GI bleeding before endoscopy. 3)Pregnant, breast-feeding women and possibility of pregnancy 4)Patients who will perform endoscopic biopsy and treatment during the same hospitalization period 5)Patients who were considered not suitable to be included in this study by the physician.

Design outcomes

Primary

MeasureTime frame
Prevalence of GI bleeding within one month after the endoscopy or endoscopic treatment

Secondary

MeasureTime frame
1. Duration of hospitalization 2. Prevalence of cardiovascular and cerebro- and systemic vascular events after endoscopy or endoscopic treatment 3. Frequency of requiring re-endoscopy 4. Frequency of massive GI bleeding 5. Frequency of massive GI bleeding threatening life 6. Frequency of cerebrovascular bleeding

Countries

Japan

Contacts

Public ContactHideki Iijima

Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology

hiijima@gh.med.osaka-u.ac.jp06-6879-3621

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026