Colonic Polyp
Conditions
Brief 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.
Interventions
DRUGEpinephrine
Epinephrine in the submucosal injection fluid
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients aged 18 years and over 2. Patients scheduled for treatment of large (≥ 20 mm) colorectal polyps 3. Able to sign informed consent
Exclusion criteria
1. Patients previously enrolled in the study 2. Pedunculated polyps 3. Polyps not amenable to endoscopic resection 4. Patients allergic or sensitive to epinephrine 5. 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. 6. Patients electing anesthesia other than monitored anesthesia care with propofol (MAC) for colonoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Post-polypectomy Pain | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| en Bloc Resection | During the colonoscopy procedure, an average of 47.3 minutes | Number of polyps removed en bloc (in 1 piece) vs number of polyps removed piecemeal (in more than 1 piece) |
| Sydney Resection Quotient | During the colonoscopy procedure, an average of 47.3 minutes | size of the polyp in mm divided by the number of pieces the polyps is removed in |
| Quality of the Mound | During the colonoscopy procedure, an average of 47.3 minutes | 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. |
| Frequency of Immediate Bleeding | During the colonoscopy procedure, an average of 47.3 minutes | Number of polyps with intraprocedural bleeding during removal |
Countries
United States
Participant flow
Pre-assignment details
Twenty-two patients consented to participate in the trial, but two patients were not randomized to either of the study arms. One patient did not have a polyp to remove (referred polyp was a lipoma). The other patient had poor bowel preparation, and the procedure was aborted.
Participants by arm
| Arm | Count |
|---|---|
| Epinephrine Epinephrine in the submucosal injection fluid (1:200,000)
Epinephrine: Epinephrine in the submucosal injection fluid | 10 |
| Epinephrine Epinephrine in the submucosal injection fluid (1:200,000)
Epinephrine: Epinephrine in the submucosal injection fluid | 11 |
| No Epinephrine Submucosal injection fluid without epinephrine | 10 |
| No Epinephrine Submucosal injection fluid without epinephrine | 10 |
| Total | 41 |
Baseline characteristics
| Characteristic | Epinephrine | No Epinephrine | Total |
|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 9.1 | 60.5 years STANDARD_DEVIATION 9.1 | 61.4 years STANDARD_DEVIATION 8.9 |
| Polyp Size | 46.7 millimeters STANDARD_DEVIATION 28.3 | 40.4 millimeters STANDARD_DEVIATION 16.1 | 43.7 millimeters STANDARD_DEVIATION 23 |
| Race/Ethnicity, Customized Unknown/Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 8 Participants | 6 Participants | 14 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 1 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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
Time frame: 30 minutes after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epinephrine | Immediate Post-polypectomy Pain | 46.5 units on a scale | Standard Deviation 32.4 |
| No Epinephrine | Immediate Post-polypectomy Pain | 13.6 units on a scale | Standard Deviation 25.9 |
Primary
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
Time frame: 1 hour after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epinephrine | Immediate Post Polypectomy Pain (1hour) | 44 Units on a Scale | Standard Deviation 27.7 |
| No Epinephrine | Immediate Post Polypectomy Pain (1hour) | 12.9 Units on a Scale | Standard Deviation 27.8 |
Secondary
en Bloc Resection
Number of polyps removed en bloc (in 1 piece) vs number of polyps removed piecemeal (in more than 1 piece)
Time frame: During the colonoscopy procedure, an average of 47.3 minutes
Population: One patient in the epinephrine group had two eligible polyps for the study so there ended up being 11 polyps in the epinephrine arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epinephrine | en Bloc Resection | En bloc removal | 0 Polyps |
| Epinephrine | en Bloc Resection | Piecemeal removal | 11 Polyps |
| No Epinephrine | en Bloc Resection | En bloc removal | 0 Polyps |
| No Epinephrine | en Bloc Resection | Piecemeal removal | 10 Polyps |
Secondary
Frequency of Immediate Bleeding
Number of polyps with intraprocedural bleeding during removal
Time frame: During the colonoscopy procedure, an average of 47.3 minutes
Population: One patient in the epinephrine group had two eligible polyps for the study so there ended up being 11 polyps in the epinephrine arm.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Epinephrine | Frequency of Immediate Bleeding | Bleeding | 2 Polyps |
| Epinephrine | Frequency of Immediate Bleeding | No bleeding | 9 Polyps |
| No Epinephrine | Frequency of Immediate Bleeding | Bleeding | 4 Polyps |
| No Epinephrine | Frequency of Immediate Bleeding | No bleeding | 6 Polyps |
Secondary
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.
Time frame: During the colonoscopy procedure, an average of 47.3 minutes
Population: One patient in the epinephrine group had two eligible polyps for the study so there ended up being 11 polyps in the epinephrine arm.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Epinephrine | Quality of the Mound | insufficient | 0 Polyps |
| Epinephrine | Quality of the Mound | Excellent/adequate | 9 Polyps |
| Epinephrine | Quality of the Mound | Unknown | 2 Polyps |
| No Epinephrine | Quality of the Mound | Excellent/adequate | 8 Polyps |
| No Epinephrine | Quality of the Mound | insufficient | 2 Polyps |
| No Epinephrine | Quality of the Mound | Unknown | 0 Polyps |
Secondary
Sydney Resection Quotient
size of the polyp in mm divided by the number of pieces the polyps is removed in
Time frame: During the colonoscopy procedure, an average of 47.3 minutes
Population: Only lesions removed by EMR with electrocautery (heat) are included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Epinephrine | Sydney Resection Quotient | 5 Ratio |
| No Epinephrine | Sydney Resection Quotient | 4.2 Ratio |