Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
GCS Ramsay Santé pour l'Enseignement et la Recherche
234 participants
Aug 21, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- Ampullary lesions
- Single ampullary lesion ≥ 10mm
- Resection via hot ampullectomy, injection/Endoscopic mucosal resection of adjacent lateral spreading component Duodenal Lesions
- ≤ 2 lesions
- Lesion ≥15mm
- Resection via hot Endoscopic mucosal resection
- Morphology: 0-Is, 0-IIa/b/c or combination, submucosal lesions
Exclusion Criteria7
- Inability to provide informed consent (including people with cognitive impairment);
- Pregnant or breastfeeding women;
- Allergy to PuraStat®;
- "Cold" mucosal endoscopic resection;
- Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
- Participating patient, or in a period of exclusion from another clinical trial;
- Patient not benefiting from a social security scheme.
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Interventions
Standard resection technique will be performed for duodenal mucosectomy, as well as the usual hemostasis at the discretion of the operator.
Standard resection technique will be performed for ampullectomy, as well as the usual hemostasis at the discretion of the operator.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05746884