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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epinephrine | Experimental | Epinephrine in the submucosal injection fluid (1:200,000) |
|
| No epinephrine | No Intervention | Submucosal injection fluid without epinephrine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinephrine | Drug | Epinephrine in the submucosal injection fluid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 1 hour after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| en Bloc Resection | Number of polyps removed en bloc (in 1 piece) vs number of polyps removed piecemeal (in more than 1 piece) | During the colonoscopy procedure, an average of 47.3 minutes |
| Sydney Resection Quotient |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Douglas K Rex, MD | IU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23022496 | Background | 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. | |
| 26077453 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Epinephrine | Epinephrine in the submucosal injection fluid (1:200,000) Epinephrine: Epinephrine in the submucosal injection fluid |
| FG001 | No Epinephrine | Submucosal injection fluid without epinephrine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Epinephrine | Epinephrine in the submucosal injection fluid (1:200,000) Epinephrine: Epinephrine in the submucosal injection fluid |
| BG001 | No Epinephrine | Submucosal injection fluid without epinephrine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 30 minutes after the procedure |
|
30 days
Patients were assessed for adverse events that occurred within 30 days after the procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epinephrine | Epinephrine in the submucosal injection fluid (1:200,000) Epinephrine: Epinephrine in the submucosal injection fluid |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| delayed bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Specialist | Indiana University | 317-948-0724 | rlahr@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2020 | May 4, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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size of the polyp in mm divided by the number of pieces the polyps is removed in
| 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. | During the colonoscopy procedure, an average of 47.3 minutes |
| Frequency of Immediate Bleeding | Number of polyps with intraprocedural bleeding during removal | During the colonoscopy procedure, an average of 47.3 minutes |
| 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. |
| 28061339 | Background | 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. |
| Background | World Health Organization. Epinephrine (for use with local anaesthetics). Model Prescribing Information: Drugs Used in Anaesthesis, Geneva, 1989:33 |
| 34896443 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| Other Units (Polyps) |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Polyp Size | Mean | Standard Deviation | millimeters | Participants |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Units on a Scale | 1 hour after procedure |
|
|
|
| Secondary | en Bloc Resection | Number of polyps removed en bloc (in 1 piece) vs number of polyps removed piecemeal (in more than 1 piece) | One patient in the epinephrine group had two eligible polyps for the study so there ended up being 11 polyps in the epinephrine arm. | Posted | Number | Polyps | During the colonoscopy procedure, an average of 47.3 minutes | Polyps | Polyps |
|
|
|
| Secondary | Sydney Resection Quotient | size of the polyp in mm divided by the number of pieces the polyps is removed in | Only lesions removed by EMR with electrocautery (heat) are included. | Posted | Median | Inter-Quartile Range | Ratio | During the colonoscopy procedure, an average of 47.3 minutes | Polyps | 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. | One patient in the epinephrine group had two eligible polyps for the study so there ended up being 11 polyps in the epinephrine arm. | Posted | Count of Units | Polyps | During the colonoscopy procedure, an average of 47.3 minutes | Polyps | Polyps |
|
|
|
| Secondary | Frequency of Immediate Bleeding | Number of polyps with intraprocedural bleeding during removal | One patient in the epinephrine group had two eligible polyps for the study so there ended up being 11 polyps in the epinephrine arm. | Posted | Count of Units | Polyps | During the colonoscopy procedure, an average of 47.3 minutes | Polyps | Polyps |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | No Epinephrine | Submucosal injection fluid without epinephrine | 0 | 10 | 0 | 10 | 1 | 10 |
| abdominal pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Unknown |
|