Temporary interruption versus maintenance of anticoagulation in polypectomy of colorectal lesions: study protocol for a multicentre randomised non-inferiority clinical trial POLYPHEM.

内容摘要

Colorectal polypectomy plays a crucial role in reducing mortality from colorectal cancer. Postpolypectomy bleeding is the most common adverse event. Current European guidelines recommend a temporary suspension of anticoagulation for polypectomy, despite the lack of high-quality evidence supporting this practice. Recent data challenge this approach, suggesting that polypectomy without discontinuing anticoagulation is not only safe but may also reduce the incidence of thromboembolic events. This multicentre, prospective randomised, endoscopist-blinded, investigator-initiated, non-inferiority clinical trial aims to compare the safety of temporary interruption versus maintenance of anticoagulation during polypectomy for colorectal lesions. A total of 481 patients on oral anticoagulant treatment (either vitamin K antagonists or direct oral anticoagulants), and scheduled for an elective colonoscopy for any indication, will be randomised in a 1:1 ratio to each group. Colonoscopy and polypectomy procedures will be conducted by experienced endoscopists at 11 Spanish hospitals. The primary outcome is clinically significant postpolypectomy haemorrhage, while the secondary outcomes involve evaluating the risk of thromboembolic events and other procedural-related variables. Non-inferiority will be assessed in the per-protocol population using an adjusted absolute risk difference margin of 10%. The study protocol was initially approved by the Medical Ethics Committee of Hospital Clínico San Carlos, Madrid, Spain (approval number: 24/330-EC_M). According to Spanish legislation on clinical trials, approval by a single CEIm is sufficient for multicentre studies and is recognised by all participating centres. The decision of the approving ethics committee is therefore applicable to all study sites. All participants will provide written informed consent prior to enrolment.The results of this study will be disseminated through publication in a peer-reviewed scientific journal and presentation at relevant national and international gastroenterology and endoscopy conferences. NCT07185295.