Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection

Launched by ERASME UNIVERSITY HOSPITAL · Oct 20, 2023

Keywords

ClinConnect Summary

This clinical trial, called NEXPOWDER-ENDOHS, is studying a new treatment called Nexpowder that aims to prevent delayed bleeding after certain types of endoscopic procedures used to remove polyps or other growths in the gastrointestinal tract. Specifically, it focuses on patients who are at high risk for bleeding after these procedures, which include upper and lower endoscopic mucosal resections (EMR) or endoscopic submucosal dissections (ESD) on larger lesions (20mm or more). The goal is to see if using Nexpowder can reduce the rate of delayed bleeding to less than 5%.

To be eligible for this trial, participants must be at least 18 years old and have signed consent to join the study. They should have a documented need for an endoscopic procedure due to lesions that are likely to cause bleeding, particularly if they are on blood-thinning medications. However, individuals with smaller lesions, those enrolled in other conflicting studies, or those who are pregnant or incapacitated cannot participate. If you join the trial, you will be monitored closely after the procedure to check for any delayed bleeding and assess the effectiveness of Nexpowder.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: ≥18 year of age at the time of informed consent,
• • Patients must have given written informed consent,
• * Subjects with documented lesions with indication of upper or lower endoscopic removal by ESD or EMR with high risk of delayed bleeding (+/-16%), namely:
• • All patients under anticoagulation (vitamin K antagonist, direct anticoagulant, non-fractionated heparin or low molecular weight heparin) or anti-aggregating (P2Y12 receptor antagonists),
• • Patients without anticoagulation or anti-aggregating with indication of duodenal EMR or ESD (if duodenal cold snare EMR: only under anticoagulant or P2Y12 receptor antagonist),
• • Resection field of ESD or EMR is ≥ 20mm (same size restriction in case of endoscopic papillectomy).
• Exclusion Criteria:
• • Resection bed \<20mm,
• • Subject currently enrolled in another interventional confounding research (no contra-indication for image or blood collection in another protocol),
• • Incapacitated subjects, pregnant or lactating women.