Glucagon Use in Colonoscopies

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of Glucagon in Outpatient Colonoscopy? A Prospective Double-Blind Randomized Controlled Trial

Conditions
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Colon Cancer

Intervention / Treatment
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* Drug: Glucagon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any subject who has already been already cleared for and scheduled to undergo colonoscopy at SFGH endoscopy center. Exclusion Criteria: Refusal to give informed consent. Age <18 or >70. Prior intra-abdominal surgery Diabetes Pheochromocytoma Insulinoma Liver disease (Child-Pugh Score >6) Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucagon<br>1 mg glucagon given during colonoscopy | Drug: Glucagon<br>* glucagon (hormone produced by the body)<br>|
| Placebo Comparator: Placebo<br>1 mL normal saline | Drug: Glucagon<br>* glucagon (hormone produced by the body)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucagon, screening colonoscopy