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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Glucagon Use in Colonoscopies

Overview

Status
Completed
Phase
Phase 4
Enrollment
100 participants (actual)
Sponsor
University of California, San Francisco · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Apr 2014
Primary completion
May 2018
Completion
May 2018
First posted
5 Mar 2014 (estimated)
Last update posted
3 Jul 2025
Conditions
Colon Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016201720182019
  1. Ph 4

    Glucagon Use in Colonoscopies

    NCT02078726

    Apr 2014 to May 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GlucagonDrug

Arms2

  • Active comparator

    Glucagon

    1 mg glucagon given during colonoscopy through an IV

  • Placebo comparator

    Placebo

    1 mL normal saline given during colonoscopy through an IV

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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)

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm)

Adenoma Detection Rate (ADR) During Colonoscopy Procedure

GroupValue (percentage of participants)
Glucagon43.75
Placebo33.33

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Glucagon1 mg glucagon given during colonoscopy Glucagon: glucagon (hormone produced by the body)0 / 640 / 640 / 64
Placebo1 mL normal saline Placebo0 / 360 / 360 / 36

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultAnupam 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).

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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