Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

Advanced endoscopic resection (ER) 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 ER 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-ER bleeding that has been adopted as standard of care. ER in the duodenum carries the highest risk for for post ER bleeding based on anatomical location. This rate is particularly high with ER of and around the ampulla/ampullectomy (~20%). 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. All patients will be given high dose PPI prophylactically and undergo standard resection technique as outlined below for EMR and Ampullectomy. The control subjects will have these interventions ALONE, while the intervention arm will have these interventions in ADDITION to gel matrix. EMR: o Gelofusine + chromo of choice + 1:100,000 adrenaline in all injections unless adrenaline contraindicated o Snare of choice but must use Endocut diathermy o Intraprocedural haemostasis defined as clips only to active bleeding point or to area of injury not to close the entire defect o Adjunctive therapy permitted for fibrosis/islands: avulsion, o Salvage Purastat allowed in both arms if uncontrollable oozing bleeding intraprocedurally Ampullectomy o Resection of laterally spreading component as per duodenal EMR protocol o Snare based resection of the ampulla without injection into the ampulla with the aim of en-bloc ampullary resection. o Intraprocedural haemostasis as indicated/clinician preference however clips only to active bleeding point or to area of MP injury not to close the entire defect o Routine placement of plastic PD stent (except if known pancreas divisum) o Routine biliary stenting o Salvage Purastat allowed in both arms if uncontrollable oozing bleeding intraprocedurally We hypothesise that the application of the topical haemostatic gel to the duodenum will reduce the rate of clinically significant bleeding. 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 via the proceduralist until the entire defect has been covered.