Adenoma
Conditions
Brief 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
Interventions
DRUGoctreotide
Octreotide 100mg subcutaneous every 8 hours for 5 days
OTHERNo Octreotide
No drug
Sponsors
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post endoscopic mucosal resection bleeding | 3 days | clinical evidence of a bleed, including melena, hematochezia, hematemesis |
Countries
United States
Outcome results
None listed