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NCT02032784 Clinical Trial

Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

Adenoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02032784
Other study ID # 541923
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date March 2014
Est. completion date July 6, 2020

Study information
Verified date July 2020
Source AdventHealth
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Terminated
Enrollment 33
Est. completion date July 6, 2020
Est. primary completion date June 28, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• octreotide
Octreotide 100mg subcutaneous every 8 hours for 5 days
Other:
• No Octreotide
No drug

Locations
Country Name City State
United States Florida Hospital Orlando Florida

Sponsors (1)
Lead Sponsor Collaborator
AdventHealth

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post endoscopic mucosal resection bleeding clinical evidence of a bleed, including melena, hematochezia, hematemesis 3 days
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