NCT02032784

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2020

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

4.3 years

First QC Date

January 8, 2014

Last Update Submit

July 15, 2020

Conditions

Adenoma

Outcome Measures

Primary Outcomes (1)

  • Post endoscopic mucosal resection bleeding

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

    3 days

Study Arms (2)

Octreotide

EXPERIMENTAL

Octreotide 100mcg subcutaneous every 8 hours for 5 days

Drug: octreotide

no octreotide

OTHER

No Octreotide

Other: No Octreotide

Interventions

octreotideDRUG

Octreotide 100mg subcutaneous every 8 hours for 5 days

Also known as: Study drug
Octreotide
No OctreotideOTHER

No drug

no octreotide

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Hospital

Orlando, Florida, 32803, United States

Location

MeSH Terms

Conditions

Adenoma

Interventions

OctreotideDrug Evaluation

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsDrug DevelopmentInvestigative TechniquesEvaluation Studies as Topic

Study Officials

  • Robert Hawes, MD

    AdventHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 10, 2014

Study Start

March 1, 2014

Primary Completion

June 28, 2018

Study Completion

July 6, 2020

Last Updated

July 16, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)