Glucagon Use in Colonoscopies

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified June 2025 by University of California, San Francisco
Sponsor
University of California, San Francisco
Information Provided by (Responsible Party)
University of California, San Francisco
Clinicaltrials.gov Identifier
NCT02078726
Other Study ID Numbers:
14-13185
First Submitted
February 23, 2014
First Posted
March 4, 2014
Results First Posted
March 23, 2021
Last Update Posted
July 2, 2025
Last Verified
June 2025

ClinicalTrials.gov processed this data on June 2025Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Colon Cancer
Drug: GlucagonDrug: Glucagon

Study Design

Study TypeInterventional
Actual Enrollment100 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeDiagnostic
Official TitleRole of Glucagon in Outpatient Colonoscopy? A Prospective Double-Blind Randomized Controlled Trial
Study Start DateMarch 31, 2014
Actual Primary Completion DateApril 30, 2018
Actual Study Completion DateApril 30, 2018

Groups and Cohorts

Group/CohortIntervention/Treatment
Glucagon
1 mg glucagon given during colonoscopy through an IV
Drug: Glucagon
glucagon (hormone produced by the body) administered through IV
Placebo
1 mL normal saline given during colonoscopy through an IV
Drug: Glucagon
glucagon (hormone produced by the body) administered through IV

Outcome Measures

Primary Outcome Measures
  1. Adenoma Detection Rate (ADR) During Colonoscopy Procedure
    ADR was defined as the percentage of participants with at least one traditional adenoma (including tubular or villous adenomas, and adenomas with high grade dysplasia or adenocarcinoma) of any size.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsUniversity of California, San Francisco
Locations
San Francisco General Hospital | San Francisco California, United States, 94117
Investigators
Principal Investigator: John Cello, MD, University of California, San Francisco
Study Documents (Full Text)
Documents provided by University of California, San FranciscoStudy Protocol, Statistical Analysis Plan, and Informed Consent Form  June 6, 2016