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Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

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ClinicalTrials.gov Identifier: NCT02032784
Recruitment Status : Recruiting
First Posted : January 10, 2014
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Florida Hospital

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 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
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

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



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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


Contacts
Contact: Robin Barron, RN, MSN 407-303-5503 Robin.Barron@flhosp.org
Contact: Robert Hawes, MD 407-303-2570 robert.hawes.md@flhosp.org

Locations
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Robin Barron, RN, MSN    407-303-5503    Robin.Barron@flhosp.org   
Contact: Robert Hawes, MD    407-303-2570    robert.hawes.MD@flhosp.org   
Principal Investigator: Robert Hawes, MD         
Sponsors and Collaborators
Florida Hospital
Investigators
Principal Investigator: Robert Hawes, MD Florida Hospital

Responsible Party: Florida Hospital
ClinicalTrials.gov Identifier: NCT02032784     History of Changes
Other Study ID Numbers: 541923
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents