Colon Adenoma, Colon Cancer, Colon Polyp
Conditions
Keywords
Polyp Resection, Cold Snare, Hot Snare, Cold Endoscopic Mucosal Resection (EMR), Hot Endoscopic Mucosal Resection (EMR), Colonoscopy
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECold 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.)
PROCEDUREHot 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.)
PROCEDURECold EMR
Subjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.)
PROCEDUREHot EMR
Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.)
Sponsors
John D. Dingell VA Medical Center
White River Junction Veterans Affairs Medical Center
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 40 years or older * Ability to provide informed consent
Exclusion criteria
* Subjects with a history of Inflammatory Bowel Disease * Lesions less than 6mm or greater than 15mm in largest dimension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Resection (Central Post-Resection Biopsies) | 1 day | 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. |
| Efficacy of Resection (Peripheral Post-Resection Biopsies) | 1 day | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.) | 59 |
| 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.) | 63 |
| 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.) | 57 |
| 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.) | 56 |
| Total | 235 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Polyp was next to a cancer and not removed | 0 | 0 | 0 | 1 |
| Overall Study | Polyp was pedunculated | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Cold EMR | Cold Snare | Hot Snare | Hot EMR | Total |
|---|---|---|---|---|---|
| Age, Continuous | 65.0 years STANDARD_DEVIATION 8 | 66.2 years STANDARD_DEVIATION 9.9 | 66.3 years STANDARD_DEVIATION 8 | 67.0 years STANDARD_DEVIATION 8.4 | 66.0 years STANDARD_DEVIATION 8.6 |
| Indication Diagnostic | 7 Participants | 7 Participants | 4 Participants | 6 Participants | 24 Participants |
| Indication Screening | 10 Participants | 17 Participants | 8 Participants | 8 Participants | 43 Participants |
| Indication Surveillance | 43 Participants | 34 Participants | 40 Participants | 41 Participants | 158 Participants |
| Indication Therapeutic | 3 Participants | 1 Participants | 5 Participants | 1 Participants | 10 Participants |
| Number of Polyps | 82 Polyps | 68 Polyps | 71 Polyps | 65 Polyps | 286 Polyps |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 2 Participants | 1 Participants | 6 Participants | 11 Participants |
| Race/Ethnicity, Customized Other/Unknown | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 60 Participants | 56 Participants | 54 Participants | 48 Participants | 218 Participants |
| Sex: Female, Male Female | 28 Participants | 25 Participants | 19 Participants | 17 Participants | 89 Participants |
| Sex: Female, Male Male | 35 Participants | 34 Participants | 38 Participants | 39 Participants | 146 Participants |
| Site Detroit Veterans Affairs Medical Center | 2 Participants | 6 Participants | 4 Participants | 9 Participants | 21 Participants |
| Site Indiana University | 47 Participants | 44 Participants | 41 Participants | 37 Participants | 169 Participants |
| Site White River Junction Veterans Affairs Medical Center | 14 Participants | 9 Participants | 12 Participants | 10 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 63 | 0 / 57 | 0 / 56 |
| other Total, other adverse events | 8 / 59 | 11 / 63 | 10 / 57 | 6 / 56 |
| serious Total, serious adverse events | 0 / 59 | 0 / 63 | 1 / 57 | 1 / 56 |
Outcome results
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.
Time frame: 1 day
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Cold Snare | Efficacy of Resection (Central Post-Resection Biopsies) | Negative | 68 Polyps |
| Cold Snare | Efficacy of Resection (Central Post-Resection Biopsies) | Positive | 0 Polyps |
| Cold EMR | Efficacy of Resection (Central Post-Resection Biopsies) | Positive | 0 Polyps |
| Cold EMR | Efficacy of Resection (Central Post-Resection Biopsies) | Negative | 82 Polyps |
| Hot Snare | Efficacy of Resection (Central Post-Resection Biopsies) | Negative | 69 Polyps |
| Hot Snare | Efficacy of Resection (Central Post-Resection Biopsies) | Positive | 2 Polyps |
| Hot EMR | Efficacy of Resection (Central Post-Resection Biopsies) | Negative | 63 Polyps |
| Hot EMR | Efficacy of Resection (Central Post-Resection Biopsies) | Positive | 2 Polyps |
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.
Time frame: 1 day
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Cold Snare | Efficacy of Resection (Peripheral Post-Resection Biopsies) | Negative | 68 Polyps |
| Cold Snare | Efficacy of Resection (Peripheral Post-Resection Biopsies) | Positive | 0 Polyps |
| Cold EMR | Efficacy of Resection (Peripheral Post-Resection Biopsies) | Positive | 1 Polyps |
| Cold EMR | Efficacy of Resection (Peripheral Post-Resection Biopsies) | Negative | 81 Polyps |
| Hot Snare | Efficacy of Resection (Peripheral Post-Resection Biopsies) | Negative | 70 Polyps |
| Hot Snare | Efficacy of Resection (Peripheral Post-Resection Biopsies) | Positive | 1 Polyps |
| Hot EMR | Efficacy of Resection (Peripheral Post-Resection Biopsies) | Negative | 62 Polyps |
| Hot EMR | Efficacy of Resection (Peripheral Post-Resection Biopsies) | Positive | 3 Polyps |