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RecruitingNot ApplicableNCT05169242

A Trial on Prophylactic Clipping to Prevent Post-polypectomy Bleeding After Colonoscopy in Direct Oral Anticoagulant Users

A Double Blinded Randomized Controlled Trial on Prophylactic Clipping to Prevent Post-polypectomy Bleeding After Colonoscopy in Direct Oral Anticoagulant Users

Sponsor

Chinese University of Hong Kong

Enrollment

584 participants

Start Date

Dec 15, 2021

Study Type

INTERVENTIONAL

Conditions

Post Polypectomy Bleeding

Summary

The investigators hypothesize that prophylactic clipping after colonoscopic polypectomy can reduce risk of delayed PPB among DOAC users. The investigators also hypothesize that pre-endoscopy drug level can predict the risk of hemorrhagic complications after the procedure.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • They are active users of any DOAC
  • They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or past gastrointestinal bleeding
  • Aged 18 years old or above;
  • Written informed consent obtained.

Exclusion Criteria9

  • Absolute contraindications to colonoscopy
  • Any medical conditions precluding interruption of DOAC for procedure
  • Any medical conditions requiring concomitant uninterrupted dual antiplatelet drugs (single antiplatelet drug users will not be excluded)
  • Active gastrointestinal bleeding
  • Clinically significant bleeding tendency (decompensated cirrhosis or severe thrombocytopenia)
  • Severe renal impairment (defined as creatinine clearance < 15 ml/min)
  • Pregnancy or lactation;
  • Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
  • Unable to obtain informed consent

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Interventions

PROCEDUREEndoclip

In the intervention arm, one or more endoclips will be used to completely close the mucosal defect after polypectomy. Prophylactic clipping will be applied to all post-polypectomy sites. The total number of endoclips used will be recorded.

Locations(1)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

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NCT05169242