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Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02032784
Recruitment Status : Terminated (Difficult to enroll subjects)
First Posted : January 10, 2014
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Adenoma Drug: octreotide Other: No Octreotide 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

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Study Type : Interventional  (Clinical Trial)
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 : March 2014
Actual Primary Completion Date : June 28, 2018
Actual Study Completion Date : July 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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 Name: Study drug

no octreotide
No Octreotide
Other: No Octreotide
No drug




Primary Outcome Measures :
  1. Post endoscopic mucosal resection bleeding [ Time Frame: 3 days ]
    clinical evidence of a bleed, including melena, hematochezia, hematemesis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032784


Locations
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United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
Sponsors and Collaborators
AdventHealth
Investigators
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Principal Investigator: Robert Hawes, MD AdventHealth
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Responsible Party: AdventHealth
ClinicalTrials.gov Identifier: NCT02032784    
Other Study ID Numbers: 541923
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents