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

NCT05169242 | Recruiting

• 1 other identifier: 2021.381
• Study Type: interventional
• Target: 584
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Polypectomy Bleeding

Outcome Measures

Primary Outcomes (1)

• Clinically significant delayed post-polypectomy bleeding

  The primary endpoint is clinically significant delayed post-polypectomy bleeding.

  2 years

Secondary Outcomes (1)

• Overall delayed post-polypectomy bleeding rate and cardio-thrombotic event rate

  2 years

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Procedure: Endoclip

Control group

NO INTERVENTION

In the control arm, no endoclip will be applied to all post-polypectomy sites, with the exceptions of uncontrolled immediate PPB or pre-treatment in very large pedunculated polyps as specified above. The subjects with endoclips applied due to safety reasons will be included in the subsequent intention-to-treat analysis, but not the per-protocol analysis.

Interventions

Endoclip PROCEDURE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

RECRUITING

Central Study Contacts

Louis Ho Shing Lau

CONTACT

35052211; louishslau@cuhk.edu.lhk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Specialist

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: December 23, 2021
• Study Start: December 15, 2021
• Primary Completion: December 14, 2024
• Study Completion: December 31, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)