Back to resultsProphylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding
Primary Purpose
Adenoma
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
octreotide
No Octreotide
Sponsored by
About this trial
This is an interventional prevention trial for Adenoma
Eligibility Criteria
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
Sites / Locations
- Florida Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Octreotide
no octreotide
Arm Description
Octreotide 100mcg subcutaneous every 8 hours for 5 days
No Octreotide
Outcomes
Primary Outcome Measures
Post endoscopic mucosal resection bleeding
clinical evidence of a bleed, including melena, hematochezia, hematemesis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02032784
Brief Title
Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding
Official Title
Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Difficult to enroll subjects
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
July 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Octreotide
Arm Type
Experimental
Arm Description
Octreotide 100mcg subcutaneous every 8 hours for 5 days
Arm Title
no octreotide
Arm Type
Other
Arm Description
No Octreotide
Intervention Type
Drug
Intervention Name(s)
octreotide
Other Intervention Name(s)
Study drug
Intervention Description
Octreotide 100mg subcutaneous every 8 hours for 5 days
Intervention Type
Other
Intervention Name(s)
No Octreotide
Intervention Description
No drug
Primary Outcome Measure Information:
Title
Post endoscopic mucosal resection bleeding
Description
clinical evidence of a bleed, including melena, hematochezia, hematemesis
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hawes, MD
Organizational Affiliation
AdventHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding
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