Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

Not Applicable

Recruiting

Conditions: Advanced duodenal mucosal/submucosal neoplasia
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery - Other surgery
Cancer - Bowel - Small bowel (duodenum and ileum)

Registration Number: ACTRN12620000208909

Lead Sponsor: iverpool Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 234

Inclusion Criteria

All patients must be
18 years old or above
Single agent (excluding aspirin) or multiple anti-thrombotic agent use ceased within 1 week prior to the procedure*

For patients with ampullary lesions;
- Single ampullary lesion
- 10mm or greater in size
- Resection via hot ampullectomy, inject/EMR of adjacent lateral spreading component
- Morphology: 0-Is, 0-IIa/b/c or combination

For patients with duodenal Lesions
- 2 or less lesions
- 15mm or greater
- Resection via hot EMR
- Morphology: 0-Is, 0-IIa/b/c or combination, submucosal lesions

*Antithrombotic therapy other than single agent aspirin is defined as
either 1) patients taking one of; warfarin, apixaban, rivaroxaban, dabigatran, clopidogrel,
prasugrel, asasantin, or any heparin based therapy, OR 2) multiple anti-thrombotic
agents (combination of any of the aforementioned therapies and/or aspirin).

Exclusion Criteria

•Unable to provide informed consent
•Age <18 years old
•Pregnant
•Allergy to Purastat
•Cold” EMR

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of delayed post-procedural bleeding requiring further intervention (such as blood transfusion, admission to hospital, or other blood products (such as platelets, fresh frozen plasma, prothrombinex)<br>This will be assessed clinically by the presence of upper gastrointestinal bleeding (such as melena or haematochezia) where patients were given blood products as documented in the medical record.[ 30 days post endoscopic procedure]

Secondary Outcome Measures

Name	Time	Method
Procedure related adverse events. This is a composite of <br>- delayed perforation (as identified on imaging such as CT or MRI, or surgically)<br>- procedure related hospitalisation <br>- Procedure related death (where the death is a direct result of the procedure or a complication of the procedure)<br>These will be assessed via review of the medical record for documented evidence of any of the adverse events mentioned above.[ 30 days post endoscopic procedure];Haemostatic gel measures <br>- volume of gel applied in mL<br>- volume of gel per cm^2 of lesion (mL/cm^2)<br>- total time (s) of gel being applied per mL of gel applied<br>- Successful application to entire post EMR defect (yes/no; as determined by the proceduralist)[ Day 0];Procedure outcome (successful EMR) - as determined by the proceduralist as complete resection of the target lesion(s). This is determined at the time of the procedure by the endoscopist and will be documented in the procedure report.[ 30 days post endoscopic procedure]