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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

Tracking Information
First Submitted Date  ICMJE January 8, 2014
First Posted Date  ICMJE January 10, 2014
Last Update Posted Date July 16, 2020
Study Start Date  ICMJE March 2014
Actual Primary Completion Date June 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2014)		 Post endoscopic mucosal resection bleeding [ Time Frame: 3 days ]
clinical evidence of a bleed, including melena, hematochezia, hematemesis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding
Official Title  ICMJE Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Adenoma
Intervention  ICMJE
  • Drug: octreotide
    Octreotide 100mg subcutaneous every 8 hours for 5 days
    Other Name: Study drug
  • Other: No Octreotide
    No drug
Study Arms  ICMJE
  • Experimental: Octreotide
    Octreotide 100mcg subcutaneous every 8 hours for 5 days
    Intervention: Drug: octreotide
  • no octreotide
    No Octreotide
    Intervention: Other: No Octreotide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 12, 2019)		 33
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2014)		 124
Actual Study Completion Date  ICMJE July 6, 2020
Actual Primary Completion Date June 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02032784
Other Study ID Numbers  ICMJE 541923
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party AdventHealth
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AdventHealth
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Hawes, MD AdventHealth
PRS Account AdventHealth
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP