Lesion; Duodenum
Conditions
Keywords
Purastat, EMR duodenum
Brief summary
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.
Interventions
DEVICEPuraStat
Purastat is applied to the EMR defect
Sponsors
3-D Matrix Europe SAS
Prof. Dr. Raf Bisschops
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The presence of active bleeding or high risk stigma of bleeding | 1 day after EMR | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The presence of clinical signs of delayed bleeding | 'During hospital stay, assessed up to 10 days' and '30 days after EMR' | The presence of hematemesis, melena, hemoglobin/hematocrit drop, hypotension or shock will be observed in the patients that had duodenal EMR with PuraStat application. |
| The presence of other adverse events | 'During hospital stay, assessed up to 10 days' and '30 days after EMR' | The presence of adverse events like perforation, severe pain, fever… will be observed in the patients that had duodenal EMR with Purastat application |
| The feasibility of PuraStat application: Amount | During EMR procedure | The amount of PuraStat will be investigated: Volume in mL |
| The feasibility of PuraStat application: Ease | During EMR procedure | The ease of application will be investigated: Questionnaire will be answered by the endoscopist. |
| The feasibility of Purastat application: Coverage | During EGD procedure | 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 |
Countries
Belgium
Contacts
Primary ContactRaf Bisschops
Backup ContactIngrid Demedts
Outcome results
None listed