Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

Phase 4

Terminated

• Conditions: Adenoma
• Interventions: Other: No Octreotide; Drug: octreotide

• Registration Number: NCT02032784
• Lead Sponsor: AdventHealth

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

Study Timeline

• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-10
• Study Start: 2014-03
• Primary Completion: 2018-06-28
• Status Verified: 2020-07
• Study Completion: 2020-07-06
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
no octreotide	No Octreotide	No Octreotide
Octreotide	octreotide	Octreotide 100mcg subcutaneous every 8 hours for 5 days

Primary Outcome Measures

Name	Time	Method
Post endoscopic mucosal resection bleeding	3 days	clinical evidence of a bleed, including melena, hematochezia, hematemesis

Trial Locations

Locations (1)

Florida Hospital; 🇺🇸 Orlando, Florida, United States