None listed
Conditions
Brief summary
The purpose of this study is to test a gel with blood-controlling properties called Purastat. This gel may be useful because bleeding a risk after endoscopy, especially if the patient uses anti-clotting medications Who is it for? You may be eligible for this study if you are aged over 18, are undergoing an endoscopic resection procedure for colorectal lesions and use an anti-clotting medication. Study details All participants in this study will undergo their procedure as scheduled. During the procedure the endoscopist will apply a few millilitres of the Purastat gel to the site of the resection. The procedure will otherwise be a per standard procedures. There will be no additional requirements from patients as part of this study – all patients will have routine care post-procedure. It is hypothesised this gel will reduce the rate of post-resection bleeding and improve outcomes for patients at risk of bleeding after endoscopic resections.
Interventions
Advanced endoscopic resection techniques such as Endoscopic Mucosal Resection (EMR) have provided a minimally invasive alternative to surgery for curative management of advanced mucosal neoplasia. The safety profile and outcomes of EMR techniques are significantly better than surgical resection however significant post resection bleeding remains an ongoing challenge. There is currently no consistently recommended strategy to reduce the risk of post-EMR bleeding that has been adopted as standard of care. In particular, patients on antithrombotic therapy are at high risk of post procedure bleeding and strategies to mitigate this are required. A recently introduced haemostatic gel (Purastat, 3D-Matrix) that acts as a self assembling nanoparticle matrix has demonstrated efficacy as a topical haemostat in controlling oozing bleeding in a number of anatomical locations including applications in ENT, Gynaecology, and endoscopy. The haemostatic gel will be applied to the post EMR mucosal defect to consecutive eligible, consenting patients undergoing endoscopic mucosal resection who are on anti-thrombotic therapy (excluding single agent aspirin) or multiple agents. We will be applying aliquots of 1-5mLs of the gel matrix; the exact amount will be determined by the size of the defect remaining post excision of the target lesion. Gel will be applied endoscopically at the time of the procedure via the proceduralist until the entire defect has been covered - this is considered the one and only time the gel will be delivered.
Sponsors
Study design
Eligibility
Inclusion criteria
Colorectal lesions Size 20mm and above 3 or less lesions per patient Single agent (excluding aspirin) or multiple anti-thrombotic agent use ceased within 1 week before the procedure and resumed within 5 days after EMR
Exclusion criteria
• Unable to provide informed consent • Age <18 years old • Pregnant • Allergy to Purastat • “Cold” endoscopic mucosal resection