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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucagon | Active Comparator | 1 mg glucagon given during colonoscopy through an IV |
|
| Placebo | Placebo Comparator | 1 mL normal saline given during colonoscopy through an IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucagon | Drug | glucagon (hormone produced by the body) administered through IV |
|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Cello, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital | San Francisco | California | 94117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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). |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glucagon | 1 mg glucagon given during colonoscopy Glucagon: glucagon (hormone produced by the body) |
| FG001 | Placebo | 1 mL normal saline Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glucagon | 1 mg glucagon given during colonoscopy Glucagon: glucagon (hormone produced by the body) |
| BG001 | Placebo | 1 mL normal saline Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | between 18 and 65 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of participants | During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm) |
|
During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glucagon | 1 mg glucagon given during colonoscopy Glucagon: glucagon (hormone produced by the body) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Cello, MD | University of California, San Francisco | 628-206-4767 | John.Cello@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 7, 2016 | Jul 1, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D005934 | Glucagon |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetes | Count of Participants | Participants |
|
| Tobacco use | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| 0 |
| 64 |
| EG001 | Placebo | 1 mL normal saline Placebo | 0 | 36 | 0 | 36 | 0 | 36 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |