Comparison of bleeding complications between cold versus hot endoscopic mucosal resection for an intermediate-sized polyp in patients with antithrombotic agents; a multicenter randomized controlled trial
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0008522
- Lead Sponsor
- Soon Chun Hyang University Hospital Seoul
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 300
Patients aged 19 and above, with a history of anticoagulant medication use within the last 30 days, who have a sessile polyp measuring 10mm or more but less than 15mm (10-15mm) in size detected during colonoscopy and are being considered for endoscopic resection.
? Patients who are unable to discontinue anticoagulant therapy based on recent guidelines and have a high risk of thromboembolic events.
? Patients who have been taking warfarin within the last 30 days.
? Cases where complete resection through endoscopic polypectomy is expected to be difficult due to endoscopic findings (visual appearance, Kudo pit pattern, Japan Narrow-Band Imaging Expert Team (JNET) classification of Type 2B or higher) indicating the possibility of invasive cancer (16).
? Cases where rescue treatment is required due to failed or incomplete resection attempts during endoscopic polypectomy.
? Patients with inflammatory bowel disease.
? Patients with hereditary colorectal tumors or the presence of 10 or more multiple polyps.
? Patients with known blood-related disorders such as leukemia, myelodysplastic syndromes, or hemophilia, or patients who have had a platelet count <100,000/uL or a coagulation disorder (aPTT > 40 seconds and/or PT INR > 1.2) within the last 3 months according to preoperative tests.
? Patients who do not consent to participate in the study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of overall bleeding rates between cold snare polypectomy (Cold-EMR) and hot snare polypectomy (Hot-EMR) according to the selection criteria in patients.
- Secondary Outcome Measures
Name Time Method Comparison of incidence of the following complications during or after the procedure ? Occurrence of mucosal bleeding during the procedure and implementation of hemostasis measures. ? Occurrence of acute post-procedural bleeding. ? Incidence of post-procedural coagulation syndrome. ? Occurrence of perforation after the procedure.;Comparison of en-bloc resection rates between cold snare polypectomy and hot snare polypectomy.;Analysis of risk factors associated with overall bleeding events.;Sub-analysis dividing patients into groups based on resumption of medication: those who resumed medication on the day following the procedure and those who resumed medication two days after the procedure, analyzing the frequency of delayed bleeding complications.