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Glucagon Use in Colonoscopies

Primary Purpose

Colon Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glucagon
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Cancer focused on measuring glucagon, screening colonoscopy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Glucagon

Placebo

Arm Description

1 mg glucagon given during colonoscopy

1 mL normal saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2014
Last Updated
March 24, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02078726
Brief Title
Glucagon Use in Colonoscopies
Official Title
Role of Glucagon in Outpatient Colonoscopy? A Prospective Double-Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
glucagon, screening colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucagon
Arm Type
Active Comparator
Arm Description
1 mg glucagon given during colonoscopy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 mL normal saline
Intervention Type
Drug
Intervention Name(s)
Glucagon
Intervention Description
glucagon (hormone produced by the body)
Primary Outcome Measure Information:
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Cello, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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).
Results Reference
result

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Glucagon Use in Colonoscopies

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