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Trial · Interventional

TerminatedPhase 4Registry data

Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

NCTNCT02032784 (opens ClinicalTrials.gov in a new tab)Other id541923
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 4
Enrollment
33 participants (actual)
Sponsor
AdventHealth · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Mar 2014
Primary completion
28 Jun 2018
Completion
6 Jul 2020
First posted
10 Jan 2014 (estimated)
Last update posted
16 Jul 2020
Conditions
Adenoma

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201620182020
  1. Ph 4

    Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

    NCT02032784

    Mar 2014 to 6 Jul 2020

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • octreotideDrug
  • No OctreotideOther

Arms2

  • Experimental

    Octreotide

    Octreotide 100mcg subcutaneous every 8 hours for 5 days

  • Other

    no octreotide

    No Octreotide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Post endoscopic mucosal resection bleeding

    Time frame · 3 days

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 89 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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