Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

ABSTRACT: Interventions: 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 spr Primary outcome(s): Rate of delayed post-procedural bleeding requiring further intervention (such as blood transfusion, admission to hospital, or other blood products (such as platelets, fresh frozen plasma, prothrombinex) This will be assessed clinically by the presence of upper gastrointestinal bleeding (such as melena or haematochezia) where patients were given blood products as documented in the medical record.[30 days post endoscopic procedure] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel

DISEASE(S): Oral And Gastrointestinal-other Diseases Of The Mouth, Teeth, Oesophagus, Digestive System Including Liver And Colon,Advanced Duodenal Mucosal/submucosal Neoplasia,Surgery-other Surgery,Cancer-bowel-small Bowel (duodenum And Ileum)

PROVIDER: 2470430 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR