NCT02032784

Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

Our hypothesis is that prophylactic administration of 5 days of Octreotide following EMR or ampullectomy in patients with duodenal and ampullary adenomas greater than or equal to 10mm.

Detailed description

Inclusion Criteria: Duodenal or ampullary adenoma greater than or equal to 10mm. Duodenal or ampullary adenoma that is suitable for endoscopic mucosal resection. Medically fit for anesthesia, endoscopy, and EMR Able to provide Informed Consent 18 years or older, male and female Exclusion criteria: Duodenal or ampullary adenoma \<10mm Duodenal or ampullary adenoma that is not suitable for endoscopic mucosal resection Medically unfit for anesthesia, endoscopy, or EMR Unable to provide Informed Consent Less than 18 years old Allergy to Octreotide

Conditions

• Adenoma

Interventions

Type	Name	Description
DRUG	octreotide	Octreotide 100mg subcutaneous every 8 hours for 5 days
OTHER	No Octreotide	No drug

Timeline

• Start date: 2014-03-01
• Primary completion: 2018-06-28
• Completion: 2020-07-06
• First posted: 2014-01-10
• Last updated: 2020-07-16

Locations

1 site across 1 country: United States