Glucagon Use in Colonoscopies

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Colon Cancer

Treatments: Drug: Glucagon

Study type: Interventional

Funder types: Other

Identifiers

NCT02078726

14-13185

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Glucagon

Active Comparator group

Description:

1 mg glucagon given during colonoscopy through an IV

Treatment:

Drug: Glucagon

Placebo

Placebo Comparator group

Description:

1 mL normal saline given during colonoscopy through an IV

Treatment:

Drug: Glucagon