Prophylactic Octreotide to Prevent Post Duodenal EMR and... | NCT02032784

Studies
Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

NCT02032784

Sponsor

AdventHealth

Status

Terminated

Last Update Posted

Jul 16, 2020Actual

Enrollment

33Actual

Phase

Phase 4

Conditions

Adenoma

Interventions

octreotide
No Octreotide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficult to enroll subjects

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Jun 28, 2018Actual

Completion Date

Jul 6, 2020Actual

First Submitted Date

Jan 8, 2014

First Submission Date that Met QC Criteria

Jan 8, 2014

First Posted Date

Jan 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2020

Last Update Posted Date

Jul 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Octreotide	Experimental	Octreotide 100mcg subcutaneous every 8 hours for 5 days	Drug: octreotide
no octreotide	Other	No Octreotide	Other: No Octreotide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
octreotide	Drug	Octreotide 100mg subcutaneous every 8 hours for 5 days	Octreotide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post endoscopic mucosal resection bleeding	clinical evidence of a bleed, including melena, hematochezia, hematemesis	3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Hawes, MD	AdventHealth	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Florida Hospital		Orlando	Florida	32803	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000236	Adenoma

Ancestor Terms

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015282	Octreotide
D004341	Drug Evaluation

Ancestor Terms

ID	Term
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided