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Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

ABSTRACT: The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Because the risk of prevalent cancer and of transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) using electrocautery snares. Resection of these large polyps is associated with a risk of severe complications that may require hospitalization and additional interventions. The most common risk is delayed bleeding which is observed in approximately 2-9% of patients. A recent retrospective study suggests that closure of the large mucosal defect after resection may decrease the risk of delayed bleeding. However, significant uncertainty remains about the polypectomy techniques to optimizing resection and minimizing risk. Important aspects that may affect risk include clipping of the mucosal defect and electrocautery setting.

DISEASE(S): Colonic Polyps,Colon Polyps,Polyps

PROVIDER: 2151180 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description: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. Primary outcome(s): Rate of clinically significant 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 gastrointestinal bleeding (such as per-rectal bleeding) where patients were given blood products as documented in the medical record.[30 days post endoscopic procedure] Study Design: Purpose: Prevention; Allocation: Non-randomised trial

Project description: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

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Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

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