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Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

Sponsor
AdventHealth (Other)
Overall Status
Terminated
CT.gov ID
NCT02032784
Collaborator
(none)
33
Enrollment
1
Location
2
Arms
76.2
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Jun 28, 2018
Actual Study Completion Date :
Jul 6, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Octreotide

Octreotide 100mcg subcutaneous every 8 hours for 5 days

Drug: octreotide
Octreotide 100mg subcutaneous every 8 hours for 5 days
Other Names:
  • Study drug

    		•
    Other: no octreotide

    No Octreotide

    Other: No Octreotide
    No drug

    Outcome Measures

    Primary Outcome Measures

    1. Post endoscopic mucosal resection bleeding [3 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Florida Hospital Orlando Florida United States 32803

    Sponsors and Collaborators

    • AdventHealth

    Investigators

    • Principal Investigator: Robert Hawes, MD, AdventHealth

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AdventHealth
    ClinicalTrials.gov Identifier:
    NCT02032784
    Other Study ID Numbers:
    • 541923
    First Posted:
    Jan 10, 2014
    Last Update Posted:
    Jul 16, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Adenoma
    Octreotide

    Study Results

    No Results Posted as of Jul 16, 2020