Pharmacological risk factor for gastrointestinal bleeding after endoscopic submucosal dissection in gastric cancer patients with direct oral anticoagulants

Pharmacological risk factor for gastrointestinal bleeding after endoscopic submucosal dissection in gastric cancer patients with direct oral anticoagulants - Pharmacological risk factor for bleeding after ESD in patients with DOAC

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000042584

Enrollment

115

Registered

2020-11-27

Start date

2020-05-01

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

Early-stage gastric cancer patients treated with DOAC

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. With consent 2. Performance status: ECOG 0 or 1 3. Early stage gastric cancer according to the treatment guideline for gastric cancer by the Japanese association of gastric cancer. 4. Over 20 years old patients treated with DOAC

Exclusion criteria

Exclusion criteria: 1. No consent 2. with three kinds of anticoagulants 3. with severe diseases (heart, liver and pulmonary failure) 4. Pregnancy

Design outcomes

Primary

Measure	Time frame
Association with plasma concentration of DOAC at trough or anti-Xa activity and incidence of bleeding after ESD for early-stage gastric cancer in patients treated with DOAC	—

Secondary

Measure	Time frame
(1) Effect of drug blood concentration (Xa activity) of DOAC (Tmax) on gastrointestinal bleeding after ESD for early gastrointestinal cancer in DOAC users (2) Influence of drug-metabolizing enzyme gene polymorphisms on post-ESD gastrointestinal bleeding in early gastrointestinal cancer (3) Effect of blood coagulation markers on gastrointestinal bleeding after ESD in early gastrointestinal cancer (4) Extraction of endoscopic features of early gastrointestinal tract for gastrointestinal bleeding after ESD in early gastrointestinal cancer (5) Extraction of pathological features of early gastrointestinal tract for gastrointestinal bleeding after ESD in early gastrointestinal cancer (6) Association of CHADs score with post-ESD gastrointestinal bleeding in early gastrointestinal cancer	—

Measure

Time frame

(1) Effect of drug blood concentration (Xa activity) of DOAC (Tmax) on gastrointestinal bleeding after ESD for early gastrointestinal cancer in DOAC users (2) Influence of drug-metabolizing enzyme gene polymorphisms on post-ESD gastrointestinal bleeding in early gastrointestinal cancer (3) Effect of blood coagulation markers on gastrointestinal bleeding after ESD in early gastrointestinal cancer (4) Extraction of endoscopic features of early gastrointestinal tract for gastrointestinal bleeding after ESD in early gastrointestinal cancer (5) Extraction of pathological features of early gastrointestinal tract for gastrointestinal bleeding after ESD in early gastrointestinal cancer (6) Association of CHADs score with post-ESD gastrointestinal bleeding in early gastrointestinal cancer

—

Countries

Japan

Contacts

Public ContactMasaki Masaki

National Hospital Organization Kyoto Medical Center Department of Gastroenterology

ds110674@outlook.jp0756419161

Outcome results