Overview
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.
Description
This is a post-marketing follow-up study of a CE marked medical device, controlled, comparative, randomized, multicentre, international single-blind.
The main objective is to evaluate the efficacy and safety of PuraStat in duodenal endoscopic mucosal resection or ampullectomy.
This study will be carried out in France in 3 investigative centers. The duration of patient participation in the study is approximately 37 days depending on the time between the selection and the endoscopic intervention.
Eligibility
Inclusion Criteria:
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 Criteria:
- 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.
