Colonic PolypPhase 4NCT04065451

Effect of Epinephrine on Post-polypectomy Pain

A Phase 4 study testing Epinephrine in people with Colonic Polyp, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Epinephrine is widely used in endoscopic mucosal resection of large polyps to prevent post-polypectomy bleeding. No previous studies looked at increase in immediate post-polypectomy pain with the use of epinephrine. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Colonic Polyp
What is being tested?: Epinephrine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 6 Jan 2020to 17 Aug 2021
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients aged 18 years and over
Patients scheduled for treatment of large (≥ 20 mm) colorectal polyps
Able to sign informed consent

Who cannot join

Patients previously enrolled in the study
Pedunculated polyps
Polyps not amenable to endoscopic resection
Patients allergic or sensitive to epinephrine
Patients with coronary artery disease who have had a myocardial infarction in the past year, or had coronary stenting in the past year, or had angina in the past year.
Patients electing anesthesia other than monitored anesthesia care with propofol (MAC) for colonoscopy

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University Hospital
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Effect of Epinephrine on Immediate Post-polypectomy Pain in Colorectal Lesions Larger Than 20 mm

Conditions: Colonic Polyp
Being tested: Epinephrine
Medical subject headings: Colonic Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EpinephrineDrug
Epinephrine in the submucosal injection fluid

Study groups in NCT04065451
Study group	Role	What they receive
Epinephrine	Experimental	Epinephrine in the submucosal injection fluid (1:200,000) Receives: Drug: Epinephrine
No epinephrine	No intervention	Submucosal injection fluid without epinephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

Immediate Post-polypectomy Pain
Pain related by the participant on a 0-100 visual analog scale; patients will be asked to mark their pain level on a straight vertical line 100 mm long and this point will be measured with a ruler for pain score. Possible values are zero- indicating no pain at all to 100-indicating worst imaginable pain
Measured: 30 minutes after the procedure
Immediate Post Polypectomy Pain (1hour)
Pain related by the participant on a 0-100 visual analog scale; patients will be asked to mark their pain level on a straight vertical line 100 mm long and this point will be measured with a ruler for pain score. Possible values are zero- indicating no pain at all to 100-indicating worst imaginable pain
Measured: 1 hour after procedure

Secondary outcomes (4)

en Bloc Resection
Number of polyps removed en bloc (in 1 piece) vs number of polyps removed piecemeal (in more than 1 piece)
Measured: During the colonoscopy procedure, an average of 47.3 minutes
Sydney Resection Quotient
size of the polyp in mm divided by the number of pieces the polyps is removed in
Measured: During the colonoscopy procedure, an average of 47.3 minutes
Quality of the Mound
Endoscopist impression of lift provided by the submucosal injection: excellent/adequate or insufficient. Excellent is the best rating and insufficient is the worst rating on this scale.
Measured: During the colonoscopy procedure, an average of 47.3 minutes
Frequency of Immediate Bleeding
Number of polyps with intraprocedural bleeding during removal
Measured: During the colonoscopy procedure, an average of 47.3 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 202017 Aug 2021

First posted22 Aug 2019
Study start6 Jan 2020
Primary completion17 Aug 2021
Study completion17 Aug 2021

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 (5)Papers the sponsor has linked to this study.
Other trials for Colonic PolypStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04065451
Sponsor's protocol ID: 1908473351
Status last verified: Sep 2022
First submitted: 15 Aug 2019
Last updated: 30 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Pohl H, Srivastava A, Bensen SP, Anderson P, Rothstein RI, Gordon SR, Levy LC, Toor A, Mackenzie TA, Rosch T, Robertson DJ. Incomplete polyp resection during colonoscopy-results of the complete adenoma resection (CARE) study. Gastroenterology. 2013 Jan;144(1):74-80.e1. doi: 10.1053/j.gastro.2012.09.043. Epub 2012 Sep 25.
PubMed 23022496
ASGE Technology Committee; Hwang JH, Konda V, Abu Dayyeh BK, Chauhan SS, Enestvedt BK, Fujii-Lau LL, Komanduri S, Maple JT, Murad FM, Pannala R, Thosani NC, Banerjee S. Endoscopic mucosal resection. Gastrointest Endosc. 2015 Aug;82(2):215-26. doi: 10.1016/j.gie.2015.05.001. Epub 2015 Jun 12.
PubMed 26077453
Klein A, Bourke MJ. How to Perform High-Quality Endoscopic Mucosal Resection During Colonoscopy. Gastroenterology. 2017 Feb;152(3):466-471. doi: 10.1053/j.gastro.2016.12.029. Epub 2017 Jan 3. No abstract available.
PubMed 28061339
World Health Organization. Epinephrine (for use with local anaesthetics). Model Prescribing Information: Drugs Used in Anaesthesis, Geneva, 1989:33
Rex DK, Lahr RE, Peterson MM, Vemulapalli KC. Impact of including epinephrine in the submucosal injectate for colorectal EMR on postprocedural pain: a randomized controlled trial. Gastrointest Endosc. 2022 Mar;95(3):535-539.e1. doi: 10.1016/j.gie.2021.11.043. Epub 2021 Dec 9.
PubMed 34896443

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colonic Polyp trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Epinephrine on Immediate Post-polypectomy Pain in Colorectal Lesions Larger Than 20 mm
ClinicalTrials.gov ID: NCT04065451
Acronym / sponsor ID: 1908473351
Conditions: Colonic Polyp
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: 6 Jan 2020 (actual)
Primary completion: 17 Aug 2021 (actual)
Study completion: 17 Aug 2021 (actual)
First posted: 22 Aug 2019 (actual)
Results: Posted 30 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Epinephrine	Experimental	Drug: EpinephrineEpinephrine in the submucosal injection fluid (1:200,000)
No epinephrine	No intervention	–Submucosal injection fluid without epinephrine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients aged 18 years and over
Patients scheduled for treatment of large (≥ 20 mm) colorectal polyps
Able to sign informed consent

Key exclusion criteria (6 listed)

Patients previously enrolled in the study
Pedunculated polyps
Polyps not amenable to endoscopic resection
Patients allergic or sensitive to epinephrine
Patients with coronary artery disease who have had a myocardial infarction in the past year, or had coronary stenting in the past year, or had angina in the past year.

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
EpinephrineEpinephrine in the submucosal injection fluid	Drug	Epinephrine

Primary outcome

Immediate Post-polypectomy Pain
Time frame: 30 minutes after the procedure
Pain related by the participant on a 0-100 visual analog scale; patients will be asked to mark their pain level on a straight vertical line 100 mm long and this point will be measured with a ruler for pain score. Possible values are zero- indicating no pain at all to 100-indicating worst imaginable pain
Immediate Post Polypectomy Pain (1hour)
Time frame: 1 hour after procedure
Pain related by the participant on a 0-100 visual analog scale; patients will be asked to mark their pain level on a straight vertical line 100 mm long and this point will be measured with a ruler for pain score. Possible values are zero- indicating no pain at all to 100-indicating worst imaginable pain

4 secondary outcomes

en Bloc Resection
Time frame: During the colonoscopy procedure, an average of 47.3 minutes
Sydney Resection Quotient
Time frame: During the colonoscopy procedure, an average of 47.3 minutes
Quality of the Mound
Time frame: During the colonoscopy procedure, an average of 47.3 minutes
Frequency of Immediate Bleeding
Time frame: During the colonoscopy procedure, an average of 47.3 minutes

Results and safety

Results posted to the registry on 30 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Epinephrine	10	10
No Epinephrine	10	10

Primary outcome: Immediate Post-polypectomy Pain

Time frame: 30 minutes after the procedure. Mean (Standard Deviation). Unit: units on a scale

Measure	Epinephrine n = 10	No Epinephrine n = 10
Value	46.5 (32.4)	13.6 (25.9)

Primary outcome: Immediate Post Polypectomy Pain (1hour)

Time frame: 1 hour after procedure. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Epinephrine n = 10	No Epinephrine n = 10
Value	44 (27.7)	12.9 (27.8)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Epinephrine	0 of 10 (0%)	1 of 10 (10%)	0 of 10
No Epinephrine	0 of 10 (0%)	1 of 10 (10%)	0 of 10

Limitations and caveats (from the sponsor): * Number of patients in study was small but sample size calculation was performed prior to initiating the study. * Study conducted by single experienced endoscopist which might limit generalizability. * Blinding to the use of epinephrine proved to not be possible due to the blanching effect of epinephrine.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23022496Pohl H, Srivastava A, Bensen SP, Anderson P, Rothstein RI, Gordon SR, Levy LC, Toor A, Mackenzie TA, Rosch T, Robertson DJ. Incomplete polyp resection during colonoscopy-results of the complete adenoma resection (CARE) study. Gastroenterology. 2013 Jan;144(1):74-80.e1. doi: 10.1053/j.gastro.2012.09.043. Epub 2012 Sep 25.
Background: PubMed 26077453ASGE Technology Committee; Hwang JH, Konda V, Abu Dayyeh BK, Chauhan SS, Enestvedt BK, Fujii-Lau LL, Komanduri S, Maple JT, Murad FM, Pannala R, Thosani NC, Banerjee S. Endoscopic mucosal resection. Gastrointest Endosc. 2015 Aug;82(2):215-26. doi: 10.1016/j.gie.2015.05.001. Epub 2015 Jun 12.
Background: PubMed 28061339Klein A, Bourke MJ. How to Perform High-Quality Endoscopic Mucosal Resection During Colonoscopy. Gastroenterology. 2017 Feb;152(3):466-471. doi: 10.1053/j.gastro.2016.12.029. Epub 2017 Jan 3. No abstract available.
BackgroundWorld Health Organization. Epinephrine (for use with local anaesthetics). Model Prescribing Information: Drugs Used in Anaesthesis, Geneva, 1989:33
Derived from this study: PubMed 34896443Rex DK, Lahr RE, Peterson MM, Vemulapalli KC. Impact of including epinephrine in the submucosal injectate for colorectal EMR on postprocedural pain: a randomized controlled trial. Gastrointest Endosc. 2022 Mar;95(3):535-539.e1. doi: 10.1016/j.gie.2021.11.043. Epub 2021 Dec 9.
Individual participant dataSharing planned: No

Related trials for Colonic Polyp

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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.

Douglas K Rex, MD principal investigator

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 Epinephrine in people with Colonic Polyp, run by Indiana University 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 3 inclusion and 6 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 30 Sep 2022. 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. 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 30 Sep 2022). 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?

Immediate Post-polypectomy Pain (time frame: 30 minutes after the procedure). The study lists 2 primary outcomes in all. 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 NCT04065451, which also lists 5 linked publications.

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 30 Sep 2022.