Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: duodenal mucosectomy, ampullectomy.
- Who it may be relevant to
- Registry conditions: Duodenal Bleeding. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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
- Procedure duodenal mucosectomy
Standard resection technique will be performed for duodenal mucosectomy, as well as the usual hemostasis at the discretion of the operator. - Procedure ampullectomy
Standard resection technique will be performed for ampullectomy, as well as the usual hemostasis at the discretion of the operator.
Primary outcome measures
- Bleeding rate requiring further intervention within 30 days [Time frame: 30 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Hôpital Privé Jean Mermoz — Lyon
Identifiers
NCT: NCT05746884 · 2022-A02660-43