Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

Conditions
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Duodenal Bleeding

Intervention / Treatment
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* Procedure: duodenal mucosectomy
* Procedure: ampullectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind, controlled, comparative, randomized, multicentre, international post-marketing follow-up study of a CE marked medical device.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group with PuraStat®<br>Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedure hemostasis at operator discretion and application of PuraStat® | Procedure: duodenal mucosectomy<br>* Standard resection technique will be performed for duodenal mucosectomy, as well as the usual hemostasis at the discretion of the operator.<br>Procedure: ampullectomy<br>* Standard resection technique will be performed for ampullectomy, as well as the usual hemostasis at the discretion of the operator.<br>|
| Active Comparator: Control Group<br>Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedural hemostasis at operator discretion | Procedure: duodenal mucosectomy<br>* Standard resection technique will be performed for duodenal mucosectomy, as well as the usual hemostasis at the discretion of the operator.<br>Procedure: ampullectomy<br>* Standard resection technique will be performed for ampullectomy, as well as the usual hemostasis at the discretion of the operator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 30 days |