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Glucagon and Colonoscopy

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ClinicalTrials.gov Identifier: NCT02078726
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The investigators believe that glucagon therapy will have a positive impact on key parameters of colonoscopy such as cecal intubation time, withdrawal time, total procedure time, adenoma detection rate, endoscopist's assessment of the difficulty of the procedure, patient comfort, and patient's willingness to undergo a repeat colonoscopy.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: Glucagon Drug: Placebo Phase 4

Detailed Description:
Glucagon transiently decreases peristalsis of smooth muscle in the gastrointestinal tract. It is widely used by radiologists to improve diagnostic yields of upper and lower GI barium contrast examinations. Glucagon is also routinely administered intravenously for all endoscopic retrograde cholangiopancreatography (ERCP) throughout the United States to facilitate canulation of the duodenal papilla and sphincterotomy. Glucagon has been used at the dose of 1-3 mg intravenously by Dr. John Cello in over 5000 ERCP examinations. The role of glucagon in facilitating colonoscopy remains controversial however and is not considered "routine". Several studies have evaluated the effect of glucagon on colonoscopy with varying results. No large scale randomized controlled trial has been performed to conclusively establish the effect of routine glucagon administration prior to colonoscopy. The investigators plan to carry out a randomized double blind, placebo controlled trial that studies key parameters of a colonoscopy such as cecal intubation time, withdrawal time, total procedure time, adenoma detection rate, endoscopist's assessment of the difficulty of the procedure, patient comfort, and patient's willingness to undergo a repeat colonoscopy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Role of Glucagon in Outpatient Colonoscopy? A Prospective Double-Blind Randomized Controlled Trial
Study Start Date : April 2014
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Glucagon

Arm Intervention/treatment
Active Comparator: Glucagon
1 mg glucagon given during colonoscopy
Drug: Glucagon
glucagon (hormone produced by the body)

Placebo Comparator: Placebo
1 mL normal saline
Drug: Placebo



Primary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: at time of primary completion date (1 year) ]
    data will be collected on all patients as they present for colonoscopy. We expect ~ 1 year of recruitment in order to achieve our desired sample size. At the time of the primary completion date, we will review all data generated from the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any subject who has already been already cleared for and scheduled to undergo colonoscopy at SFGH endoscopy center.

Exclusion Criteria:

  1. Refusal to give informed consent.
  2. Age <18 or >70.
  3. Prior intra-abdominal surgery
  4. Diabetes
  5. Pheochromocytoma
  6. Insulinoma
  7. Liver disease (Child-Pugh Score >6)
  8. Pregnancy

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): NCT02078726


Locations
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United States, California
San Francisco General Hospital
San Francisco, California, United States, 94117
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: John Cello, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02078726     History of Changes
Other Study ID Numbers: 14-13185
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

Keywords provided by University of California, San Francisco:
glucagon, screening colonoscopy

Additional relevant MeSH terms:
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Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins