Prevention of Post-Polypectomy Colorectal Bleeding by Clips in Patients on Anticoagulants (PiCAnt)

Helios Kliniken Schwerin

Status: Enrolling

Conditions: Polyp of Colon

Treatments: Device: Hemostatic clip

Study type: Observational

Funder types: Other

Identifiers

NCT07007598

HeliosSchwerin GAS 01

Details and patient eligibility

About

This observational study aims to retrospectively determine if clips can prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy, using a large, single-center patient registry.

The main question it aims to answer is:

Can clips prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy? Researchers will compare adults who received preventive clipping after a polypectomy with those who did not, regarding colorectal bleeding after receiving restarted anticoagulants.

Participants have undergone a colorectal polypectomy and received restarted anticoagulants (acetylsalicylic acid excluded) after the procedure.

Full description

Screening colonoscopy allows early detection of cancer and removal of adenomas before they become malignant. Unresected polyps larger than 1 cm have a 24% risk of invasive adenocarcinoma. Post-polypectomy bleeding is influenced by factors such as polyp size, location, tumor type, anticoagulants and concomitant diseases. Prophylactic measures such as clipping show mixed results; selective clipping is cost-effective, but universal clipping is not. The updated ESGE guideline on colorectal polypectomy and endoscopic mucosal resection from 2024 recommends prophylactic endoscopic clip of the mucosal defect after endoscopic mucosal resection of large non-pedunculated polyps in the right colon to reduce the risk of delayed bleeding. However, there is no clear recommendation for patients on anticoagulants whether to use or not to use prophylactic clipping. Therefore, this observational study aims to retrospectively determine if clips can prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy, using a large, single-center patient registry (> 10.000 colonoscopies).

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult who has received a colonoscopy with endoscopic colorectal polypectomy
• patient who has received at least one anticoagulant after polypectomy

Exclusion criteria

• Endoscopic polypectomy was combined with closure of the mucosal defect by a suturing device or full thickness resection device

Trial design

10,000 participants in 2 patient groups

Colorectal polypectomy and prophylactic clipping before restarted anticoagulants

Description:

At least one prophylactic clip is applied to close the mucosal defect after polypectomy

Treatment:

Device: Hemostatic clip

Colorectal polypectomy without prophylactic clipping before restarted anticoagulant

Description:

A prophylactic clip is not applied to close the mucosal defect after polypectomy.