Glucagon and Colonoscopy
Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colon Cancer
Intervention: Glucagon (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s):
John Cello, MD, Principal Investigator, Affiliation: University of California, San Francisco
Overall contact:
Anupam Aditi, MD, Phone: 415 206 4754, Email: anupam.aditi@ucsf.edu
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.
Clinical Details
Official title: Role of Glucagon in Outpatient Colonoscopy? A Prospective Double-Blind Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
Primary outcome: Adenoma detection rate
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Anupam Aditi, MD, Phone: 415 206 4754, Email: anupam.aditi@ucsf.edu
San Francisco General Hospital, San Francisco, California 94117, United States; Recruiting
Alex Rodas, Email: arodas@medsfgh.ucsf.edu
Anupam Aditi, MD, Principal Investigator
John Cello, MD, Principal Investigator
Additional Information
Starting date: April 2014
Last updated: June 4, 2015
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