Clinical trial NCT02078726: Glucagon Use in Colonoscopies
Official title: Role of Glucagon in Outpatient Colonoscopy? A Prospective Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colon Cancer
Keywords: glucagon, screening colonoscopy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Adenoma Detection Rate (ADR) During Colonoscopy Procedure
timeFrame: During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm)
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: John Cello, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anupam Aditi, Trilokesh Dey Kidambi, Angel Espinoza, Nicholas Crowley, Alex Rodas, John Patrick Cello. Glucagon Shortens Cecal Intubation Time and Total Procedure Time During Colonoscopy: A Prospective, Double-Blind Placebo Controlled Randomized Trial. Biomedical Journal of Scientific & Technical Research. 2019; 22(2).