Colon CancerPhase 4NCT02078726
Glucagon Use in Colonoscopies
A Phase 4 study testing Glucagon in people with Colon Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any subject who has already been already cleared for and scheduled to undergo colonoscopy at SFGH endoscopy center.
Who cannot join
- Refusal to give informed consent.
- Age <18 or >70.
- Prior intra-abdominal surgery
- Diabetes
- Pheochromocytoma
- Insulinoma
- Liver disease (Child-Pugh Score >6)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94117
About this study
Official title: Role of Glucagon in Outpatient Colonoscopy? A Prospective Double-Blind Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Colon Cancer
- Being tested
- Glucagon
- Keywords
- glucagon, screening colonoscopy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucagonDrug
glucagon (hormone produced by the body) administered through IV
| Study group | Role | What they receive |
|---|---|---|
| Glucagon | Active comparator | 1 mg glucagon given during colonoscopy through an IV Receives: Drug: Glucagon |
| Placebo | Placebo comparator | 1 mL normal saline given during colonoscopy through an IV Receives: Drug: Glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Cello, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078726
- Sponsor's protocol ID
- 14-13185
- Status last verified
- Jul 2025
- First submitted
- 24 Feb 2014
- Last updated
- 3 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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).
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Glucagon in Outpatient Colonoscopy? A Prospective Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02078726
- Acronym / sponsor ID
- 14-13185
- Conditions
- Colon Cancer
- Keywords
- glucagon, screening colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Posted 20 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucagon | Active comparator | Drug: Glucagon1 mg glucagon given during colonoscopy through an IV |
| Placebo | Placebo comparator | Drug: Glucagon1 mL normal saline given during colonoscopy through an IV |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any subject who has already been already cleared for and scheduled to undergo colonoscopy at SFGH endoscopy center.
Key exclusion criteria (8 listed)
- Refusal to give informed consent.
- Age <18 or >70.
- Prior intra-abdominal surgery
- Diabetes
- Pheochromocytoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucagonglucagon (hormone produced by the body) administered through IV | Drug | Glucagon, Placebo |
Primary outcome
Adenoma Detection Rate (ADR) During Colonoscopy Procedure
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationAnupam 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Cello, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucagon in people with Colon Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma Detection Rate (ADR) During Colonoscopy Procedure (time frame: During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02078726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.