Lesion; Duodenum Clinical Trial
Official title:
A Study to Evaluate the Effectiveness of Purastat® in the Prevention of Delayed Bleeding After EMR of Non-ampullary Duodenal Lesions
| NCT number | NCT04629768 |
| Other study ID # | S63851 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2, 2020 |
| Est. completion date | September 2023 |
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.
| Status | Recruiting |
| Enrollment | 59 |
| Est. completion date | September 2023 |
| Est. primary completion date | October 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospitals Leuven | Leuven |
| Lead Sponsor | Collaborator |
|---|---|
| Prof. Dr. Raf Bisschops | 3-D Matrix Europe SAS |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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' | |
| Secondary | 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' | |
| Secondary | The feasibility of PuraStat application: Amount | The amount of PuraStat will be investigated: Volume in mL | During EMR procedure | |
| Secondary | The feasibility of PuraStat application: Ease | The ease of application will be investigated: Questionnaire will be answered by the endoscopist. | During EMR procedure | |
| Secondary | 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 |