Glucagon Use in Colonoscopies

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT02078726
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer	Drug: Glucagon	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: Role of Glucagon in Outpatient Colonoscopy? A Prospective Double-Blind Randomized Controlled Trial
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Glucagon 1 mg glucagon given during colonoscopy	Drug: Glucagon; glucagon (hormone produced by the body)
Placebo Comparator: Placebo 1 mL normal saline	Drug: Glucagon; glucagon (hormone produced by the body)

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco General Hospital	San Francisco	California	United States	94117

Sponsors and Collaborators

• University of California, San Francisco

Investigators

• Principal Investigator: John Cello, MD, University of California, San Francisco

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 6, 2017

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02078726
• Other Study ID Numbers: 14-13185
• First Posted: Mar 5, 2014
• Last Update Posted: Apr 20, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by University of California, San Francisco: glucagon, screening colonoscopy
• Additional relevant MeSH terms: Colonic Neoplasms; Glucagon

Study Results

Participant Flow

Arm/Group Title	Glucagon	Placebo
Arm/Group Description	1 mg glucagon given during colonoscopy Glucagon: glucagon (hormone produced by the body)	1 mL normal saline Placebo
Period Title: Overall Study
STARTED	64	36
COMPLETED	64	36
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Glucagon	Placebo	Total
Arm/Group Description	1 mg glucagon given during colonoscopy Glucagon: glucagon (hormone produced by the body)	1 mL normal saline Placebo	Total of all reporting groups
Overall Participants	64	36	100
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	64 100%	36 100%	100 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	30 46.9%	19 52.8%	49 49%
Male	34 53.1%	17 47.2%	51 51%
Race/Ethnicity, Customized (Count of Participants)
Asian	30 46.9%	12 33.3%	42 42%
Hispanic	16 25%	9 25%	25 25%
Caucasian	14 21.9%	9 25%	23 23%
African American	4 6.3%	5 13.9%	9 9%
Other	0 0%	1 2.8%	1 1%
Region of Enrollment (participants) [Number]
United States	64 100%	36 100%	100 100%
Diabetes (Count of Participants)
Count of Participants [Participants]	18 28.1%	8 22.2%	26 26%
Tobacco use (Count of Participants)
Count of Participants [Participants]	21 32.8%	5 13.9%	26 26%

Outcome Measures

1. Primary Outcome

Title	Adenoma Detection Rate (ADR) During Colonoscopy Procedure
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Glucagon	Placebo
Arm/Group Description	1 mg glucagon given during colonoscopy Glucagon: glucagon (hormone produced by the body)	1 mL normal saline Placebo
Measure Participants	64	36
Number [percentage of participants]	43.75 68.4%	33.33 92.6%

Adverse Events

Time Frame	During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm)
Arm/Group Title	Glucagon		Placebo
Arm/Group Description	1 mg glucagon given during colonoscopy Glucagon: glucagon (hormone produced by the body)		1 mL normal saline Placebo
All Cause Mortality
	Glucagon		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/36 (0%)
Serious Adverse Events
	Glucagon		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	Glucagon		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/36 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.