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| Name | Class |
|---|---|
| John D. Dingell VA Medical Center | FED |
| White River Junction Veterans Affairs Medical Center | FED |
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The study will compare the use of cold snare, hot snare, cold EMR, and hot EMR for polyp resection. Although previous studies have compared two of the potential resection methods, no previous study has evaluated all four of the resection methods.
The optimal method for removal of polyps 6-9 and 10-15 mm in size is not established. In this study, we propose to evaluate four different treatments for polyps (sized 6mm-15mm). The four treatments are cold snaring without injection, hot snaring without injection, cold EMR, and hot EMR. This study aims to help to establish the optimal resection technique for 6-9 and 10-15 mm polyps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold Snare | Experimental | Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold snare techniques. |
|
| Hot Snare | Experimental | Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques. |
|
| Cold EMR | Experimental | Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques. |
|
| Hot EMR | Experimental | Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold Snare | Procedure | Subjects randomized to Cold Snare Intervention will have any polyps sized 6mm to 15mm removed using cold snare techniques (no electrocautery, no submucosal injection.) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Resection (Central Post-Resection Biopsies) | Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the central post-resection biopsies. Positive means that there was residual polyp tissue seen on the central post-resection biopsies. Negative central post-resection biopsies are considered a better outcome. | 1 day |
| Efficacy of Resection (Peripheral Post-Resection Biopsies) | Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the peripheral post-resection biopsies. Positive means that there was residual polyp tissue seen on the peripheral post-resection biopsies. Negative peripheral post-resection biopsies are considered a better outcome. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas K Rex, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35288147 | Derived | Rex DK, Anderson JC, Pohl H, Lahr RE, Judd S, Antaki F, Lilley K, Castelluccio PF, Vemulapalli KC. Cold versus hot snare resection with or without submucosal injection of 6- to 15-mm colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2022 Aug;96(2):330-338. doi: 10.1016/j.gie.2022.03.006. Epub 2022 Mar 12. |
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De-identified data may be shared in the future upon request per PI discretion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cold Snare | Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold snare techniques. Cold Snare: Subjects randomized to Cold Snare Intervention will have any polyps sized 6mm to 15mm removed using cold snare techniques (no electrocautery, no submucosal injection.) |
| FG001 | Cold EMR | Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques. Cold EMR: Subjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.) |
| FG002 | Hot Snare | Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques. Hot Snare: Subjects randomized to Hot Snare Intervention will have any polyps sized 6mm to 15mm removed using hot snare techniques (with electrocautery, no submucosal injection.) |
| FG003 | Hot EMR | Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques. Hot EMR: Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cold Snare | Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold snare techniques. Cold Snare: Subjects randomized to Cold Snare Intervention will have any polyps sized 6mm to 15mm removed using cold snare techniques (no electrocautery, no submucosal injection.) |
| BG001 |
| 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 | Efficacy of Resection (Central Post-Resection Biopsies) | Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the central post-resection biopsies. Positive means that there was residual polyp tissue seen on the central post-resection biopsies. Negative central post-resection biopsies are considered a better outcome. | Posted | Count of Units | Polyps | 1 day | Polyps | Polyps |
|
1 month
Patients were called approximately 30 days after their colonoscopy 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 | Cold Snare | Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold snare techniques. Cold Snare: Subjects randomized to Cold Snare Intervention will have any polyps sized 6mm to 15mm removed using cold snare techniques (no electrocautery, no submucosal injection.) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| delayed hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment | Delayed bleeding requiring treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraprocedural bleed from biopsy | Injury, poisoning and procedural complications | Systematic Assessment |
Study endoscopists are experts with special interest in polypectomy; serrated lesions were included in the study instead of only including adenomas; incomplete resections occurred in 10-15mm lesions so a study designed for 10-15mm or 10-20mm lesions may be more relevant; potential of proceduralist bias due to lack of endoscopist blinding; relying on biopsies of the defect instead of evaluation of scars at surveillance for determining efficacy
| 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 | Feb 24, 2020 | Apr 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Hot Snare | Procedure | Subjects randomized to Hot Snare Intervention will have any polyps sized 6mm to 15mm removed using hot snare techniques (with electrocautery, no submucosal injection.) |
|
| Cold EMR | Procedure | Subjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.) |
|
| Hot EMR | Procedure | Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.) |
|
| Polyp was next to a cancer and not removed |
|
| Cold EMR |
Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques. Cold EMR: Subjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.) |
| BG002 | Hot Snare | Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques. Hot Snare: Subjects randomized to Hot Snare Intervention will have any polyps sized 6mm to 15mm removed using hot snare techniques (with electrocautery, no submucosal injection.) |
| BG003 | Hot EMR | Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques. Hot EMR: Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Number of Polyps | Number | Polyps |
|
| Indication | Count of Participants | Participants |
|
| Site | Count of Participants | Participants |
|
| OG001 | Cold EMR | Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques. Cold EMR: Subjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.) |
| OG002 | Hot Snare | Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques. Hot Snare: Subjects randomized to Hot Snare Intervention will have any polyps sized 6mm to 15mm removed using hot snare techniques (with electrocautery, no submucosal injection.) |
| OG003 | Hot EMR | Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques. Hot EMR: Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.) |
|
|
| Primary | Efficacy of Resection (Peripheral Post-Resection Biopsies) | Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the peripheral post-resection biopsies. Positive means that there was residual polyp tissue seen on the peripheral post-resection biopsies. Negative peripheral post-resection biopsies are considered a better outcome. | Posted | Count of Units | Polyps | 1 day | Polyps | Polyps |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 8 |
| 59 |
| EG001 | Cold EMR | Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques. Cold EMR: Subjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.) | 0 | 63 | 0 | 63 | 11 | 63 |
| EG002 | Hot Snare | Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques. Hot Snare: Subjects randomized to Hot Snare Intervention will have any polyps sized 6mm to 15mm removed using hot snare techniques (with electrocautery, no submucosal injection.) | 0 | 57 | 1 | 57 | 10 | 57 |
| EG003 | Hot EMR | Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques. Hot EMR: Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.) | 0 | 56 | 1 | 56 | 6 | 56 |
|
| Delayed Bleed | Injury, poisoning and procedural complications | Systematic Assessment | Bleeding noticed after procedure but not requiring intervention |
|
| Abdominal pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Urinary incontinence or retention | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bowel Movement Irregularity | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Medication Reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Other, Miscellaneous | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Polyps |
|
| Positive |
|