Colorectal EMR and ESD on continuous use of anticoagulants.

UMIN ID: UMIN000018655

Registered date:12/08/2015

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: 1. Patinets taking anticoagulants because of thrombotic risk (CHADS2 score more than 2 or mechnical valve replacement) 2. Colorectal polyps more than 5mm in diameter 3. Within 3 polyps can be resected in one procedure 4. Over 20 years old 5. PS(ECOG)0, 1, 2 6. patients without severe anemia, moderate to severe thrombocytopenia, severe liver dysfunction and severe renal dysfunction
• Date of first enrollment: 2015/03/17
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): anticoagulant therapy

Outcome(s)

• Primary Outcome: Lower gastrointestinal hemorrhage after endoscopic resetion
• Secondary Outcome: Hemorrhage not related with endoscopic therapy, thrombotic complications, perforation, other complications.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients taking antithrombotic agents other than warfarin or NOAC. Patients taking NSAIDs and not able to interrupt 7 days before endoscopic therapy and 28 days after therapy. Female who are pregnant or lactating. Patients who have psychiatric disease. patients who have active bacterial infection or fungal infection. Patients with poor control hypertension(SBP more than 160mmHg or DBP more than 100mmHg). Patients with chronic lung disease who need continuous oxygen therapy.

Related Information

• Primary Sponsor: Division of Gastroenterology Teikyo University Chiba Medical Center
• Secondary Sponsor: Shin-Tokyo Hospital
• Source(s) of Monetary Support: AstraZeneca,Bristol-Myers Squibb