Purastat Prevention Delayed Bleeding Duodenum

Prof. Dr. Raf Bisschops59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Lesion; Duodenum

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 1 day after EMR

Secondary Outcomes

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.

Time frame: '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

Time frame: '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

Time frame: During EMR procedure

The feasibility of PuraStat application: Ease

The ease of application will be investigated: Questionnaire will be answered by the endoscopist.

Time frame: 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

Time frame: During EGD procedure