Clinical Trial: Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

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 Summary:

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


Sponsor: Florida Hospital

Current Primary Outcome: Post endoscopic mucosal resection bleeding [ Time Frame: 3 days ]

clinical evidence of a bleed, including melena, hematochezia, hematemesis


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Florida Hospital

Dates:
Date Received: January 8, 2014
Date Started: March 2014
Date Completion: December 31, 2018
Last Updated: February 13, 2017
Last Verified: February 2017