Colon Cancer
Conditions
Keywords
glucagon, screening colonoscopy
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.
Interventions
DRUGGlucagon
glucagon (hormone produced by the body) administered through IV
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Detection Rate (ADR) During Colonoscopy Procedure | During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Glucagon 1 mg glucagon given during colonoscopy
Glucagon: glucagon (hormone produced by the body) | 64 |
| Placebo 1 mL normal saline
Placebo | 36 |
| Total | 100 |
Baseline characteristics
| Characteristic | Total | Placebo | Glucagon |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 36 Participants | 64 Participants |
| Diabetes | 26 Participants | 8 Participants | 18 Participants |
| Race/Ethnicity, Customized African American | 9 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 42 Participants | 12 Participants | 30 Participants |
| Race/Ethnicity, Customized Caucasian | 23 Participants | 9 Participants | 14 Participants |
| Race/Ethnicity, Customized Hispanic | 25 Participants | 9 Participants | 16 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment United States | 100 participants | 36 participants | 64 participants |
| Sex: Female, Male Female | 49 Participants | 19 Participants | 30 Participants |
| Sex: Female, Male Male | 51 Participants | 17 Participants | 34 Participants |
| Tobacco use | 26 Participants | 5 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 36 |
| other Total, other adverse events | 0 / 64 | 0 / 36 |
| serious Total, serious adverse events | 0 / 64 | 0 / 36 |
Outcome results
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.
Time frame: During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glucagon | Adenoma Detection Rate (ADR) During Colonoscopy Procedure | 43.75 percentage of participants |
| Placebo | Adenoma Detection Rate (ADR) During Colonoscopy Procedure | 33.33 percentage of participants |