Duodenal Bleeding
Conditions
Brief 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.
Detailed 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.
Interventions
PROCEDUREduodenal mucosectomy
Standard resection technique will be performed for duodenal mucosectomy, as well as the usual hemostasis at the discretion of the operator.
PROCEDUREampullectomy
Standard resection technique will be performed for ampullectomy, as well as the usual hemostasis at the discretion of the operator.
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Euraxi Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
single blind
Intervention model description
Single-blind, controlled, comparative, randomized, multicentre, international post-marketing follow-up study of a CE marked medical device.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding rate requiring further intervention within 30 days | 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) |
Countries
France
Contacts
CONTACTSarah LEBLANC, MD
Outcome results
None listed