Purastat Prevention Delayed Bleeding Duodenum

Study Overview
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Brief Summary
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PuraStat is a viscous solution of synthetic peptides that provides a physical barrier to facilitate hemostasis. It is indicated for haemostasis in a variety of surgical indications. In this study the efficacy of PuraStat in reducing delayed bleeding following duodenal endoscopic mucosal resection (EMR) will be assessed. PuraStat will be applied to the EMR defect after the resection. The presence of active bleeding or high risk stigma of bleeding will be observed on an esophagogastroduodenoscopy (EGD) performed 1 day after the duodenal EMR. Furthermore the presence of clinical signs of delayed bleeding, other adverse events and the feasibility of PuraStat application will be assessed.

Official Title
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A Study to Evaluate the Effectiveness of Purastat® in the Prevention of Delayed Bleeding After EMR of Non-ampullary Duodenal Lesions

Conditions
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Lesion; Duodenum

Intervention / Treatment
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* Device: PuraStat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Duodenal non-ampullary mucosal lesion ≥ 10 mm ≥ 18y of age Informed consent obtained Exclusion Criteria: Ampulloma Submucosal lesion Lesion < 10 mm >1 lesion resected Active use of anticoagulant or antithrombotic medication other than aspirin Known clotting disorder Inability to give informed consent < 18y of age

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Duodenal EMR + PuraStat<br>PuraStat will be applied to the defect after duodenal EMR of the lesion | Device: PuraStat<br>* Purastat is applied to the EMR defect<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of active bleeding or high risk stigma of bleeding | On an EGD, performed the day after the duodenal EMR with PuraStat application, the presence of active bleeding or the presence of visible vessels after removal of a blood clot will be observed | 1 day after EMR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of clinical signs of delayed bleeding | The presence of hematemesis, melena, hemoglobin/hematocrit drop, hypotension or shock will be observed in the patients that had duodenal EMR with PuraStat application. | 'During hospital stay, assessed up to 10 days' and '30 days after EMR' | 
| The presence of other adverse events | The presence of adverse events like perforation, severe pain, fever… will be observed in the patients that had duodenal EMR with Purastat application | 'During hospital stay, assessed up to 10 days' and '30 days after EMR' | 
| The feasibility of PuraStat application: Amount | The amount of PuraStat will be investigated: Volume in mL | During EMR procedure | 
| The feasibility of PuraStat application: Ease | The ease of application will be investigated: Questionnaire will be answered by the endoscopist. | During EMR procedure | 
| The feasibility of Purastat application: Coverage | Is PuraStat covering the resection defect the day after the EMR? This will be investigated by questionnaire that will be answered by the endoscopist who performs the EGD | During EGD procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Purastat, EMR duodenum