Trial Outcomes & Findings for Quad Resection (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR) (NCT NCT03462706)
NCT ID: NCT03462706
Last Updated: 2023-02-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
238 participants
Primary outcome timeframe
1 day
Results posted on
2023-02-15
Participant Flow
Participant milestones
| Measure |
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.)
|
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.)
|
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.)
|
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.)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
63
|
58
|
57
|
|
Overall Study
COMPLETED
|
59
|
63
|
57
|
56
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.)
|
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.)
|
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.)
|
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.)
|
|---|---|---|---|---|
|
Overall Study
Polyp was pedunculated
|
1
|
0
|
1
|
0
|
|
Overall Study
Polyp was next to a cancer and not removed
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Quad Resection (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)
Baseline characteristics by cohort
| Measure |
Cold Snare
n=59 Participants
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.)
|
Cold EMR
n=63 Participants
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.)
|
Hot Snare
n=57 Participants
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.)
|
Hot EMR
n=56 Participants
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.)
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
65.0 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
66.0 years
STANDARD_DEVIATION 8.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
146 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
56 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
218 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Number of Polyps
|
68 Polyps
n=5 Participants
|
82 Polyps
n=7 Participants
|
71 Polyps
n=5 Participants
|
65 Polyps
n=4 Participants
|
286 Polyps
n=21 Participants
|
|
Indication
Diagnostic
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Indication
Screening
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Indication
Surveillance
|
34 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
158 Participants
n=21 Participants
|
|
Indication
Therapeutic
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Site
Indiana University
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
169 Participants
n=21 Participants
|
|
Site
Detroit Veterans Affairs Medical Center
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Site
White River Junction Veterans Affairs Medical Center
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 dayEfficacy 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.
Outcome measures
| Measure |
Cold Snare
n=68 Polyps
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.)
|
Cold EMR
n=82 Polyps
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.)
|
Hot Snare
n=71 Polyps
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.)
|
Hot EMR
n=65 Polyps
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.)
|
|---|---|---|---|---|
|
Efficacy of Resection (Central Post-Resection Biopsies)
Negative
|
68 Polyps
|
82 Polyps
|
69 Polyps
|
63 Polyps
|
|
Efficacy of Resection (Central Post-Resection Biopsies)
Positive
|
0 Polyps
|
0 Polyps
|
2 Polyps
|
2 Polyps
|
PRIMARY outcome
Timeframe: 1 dayEfficacy 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.
Outcome measures
| Measure |
Cold Snare
n=68 Polyps
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.)
|
Cold EMR
n=82 Polyps
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.)
|
Hot Snare
n=71 Polyps
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.)
|
Hot EMR
n=65 Polyps
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.)
|
|---|---|---|---|---|
|
Efficacy of Resection (Peripheral Post-Resection Biopsies)
Negative
|
68 Polyps
|
81 Polyps
|
70 Polyps
|
62 Polyps
|
|
Efficacy of Resection (Peripheral Post-Resection Biopsies)
Positive
|
0 Polyps
|
1 Polyps
|
1 Polyps
|
3 Polyps
|
Adverse Events
Cold Snare
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cold EMR
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Hot Snare
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Hot EMR
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cold Snare
n=59 participants at risk
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.)
|
Cold EMR
n=63 participants at risk
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.)
|
Hot Snare
n=57 participants at risk
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.)
|
Hot EMR
n=56 participants at risk
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.)
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
delayed hemorrhage
|
0.00%
0/59 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
0.00%
0/63 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
1.8%
1/57 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
1.8%
1/56 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
Other adverse events
| Measure |
Cold Snare
n=59 participants at risk
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.)
|
Cold EMR
n=63 participants at risk
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.)
|
Hot Snare
n=57 participants at risk
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.)
|
Hot EMR
n=56 participants at risk
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.)
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Intraprocedural bleed from biopsy
|
0.00%
0/59 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
1.6%
1/63 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
7.0%
4/57 • Number of events 4 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
3.6%
2/56 • Number of events 2 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
|
Injury, poisoning and procedural complications
Delayed Bleed
|
5.1%
3/59 • Number of events 3 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
4.8%
3/63 • Number of events 3 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
3.5%
2/57 • Number of events 2 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
1.8%
1/56 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
|
Injury, poisoning and procedural complications
Abdominal pain
|
6.8%
4/59 • Number of events 4 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
7.9%
5/63 • Number of events 5 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
3.5%
2/57 • Number of events 2 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
1.8%
1/56 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
|
Injury, poisoning and procedural complications
Urinary incontinence or retention
|
0.00%
0/59 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
1.6%
1/63 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
0.00%
0/57 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
1.8%
1/56 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
|
Injury, poisoning and procedural complications
Bowel Movement Irregularity
|
1.7%
1/59 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
0.00%
0/63 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
1.8%
1/57 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
0.00%
0/56 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
|
Injury, poisoning and procedural complications
Medication Reaction
|
0.00%
0/59 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
1.6%
1/63 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
0.00%
0/57 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
1.8%
1/56 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
|
Injury, poisoning and procedural complications
Other, Miscellaneous
|
1.7%
1/59 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
1.6%
1/63 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
1.8%
1/57 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
0.00%
0/56 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place