The purpose of this study is to test whether prophylactic application of haemostatic gel will reduce the rate of clinically significant bleeding requiring intervention (such as blood transfusion, admission to hospital, other blood products) following endoscopic resection of advanced duodenal neoplasia compared to standard therapy.
Single ampullary lesion ≥ 10mm
Resection via hot ampullectomy, injection/Endoscopic mucosal resection of adjacent lateral spreading component Duodenal Lesions
≤ 2 lesions
Lesion ≥15mm
Inability to provide informed consent (including people with cognitive impairment);
Pregnant or breastfeeding women;
Allergy to PuraStat®;
"Cold" mucosal endoscopic resection;
Parallel
duodenal mucosectomy
Procedure/SurgeryStandard resection technique will be performed for duodenal mucosectomy, as well as the usual hemostasis at the discretion of the operator.
ampullectomy
Procedure/SurgeryStandard resection technique will be performed for ampullectomy, as well as the usual hemostasis at the discretion of the operator.
Bleeding rate requiring further intervention within 30 days
Rate of clinically significant delayed postoperative bleeding requiring further intervention within 30 days (such as blood transfusion, packed cell transfusion or administration of other blood products, hospitalization or repeat endoscopy)
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GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead sponsor
Euraxi Pharma
Collaborator
