Trial Outcomes & Findings for Post-resection Treatment of Large Colon Polyps (NCT NCT03654209)

Last Updated: 2024-01-05

Results Overview

The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy

Recruitment status

COMPLETED

Study phase

Target enrollment

384 participants

Primary outcome timeframe

1 day

Results posted on

2024-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Argon Plasma Coagulation Following polyp removal using standard of care methods, Argon Plasma Coagulation (APC) will be applied to the perimeter of the resection site before any clips are added. Argon Plasma Coagulation: APC will be applied to the perimeter of the resection site	Snare Tip Soft Coagulation Following polyp removal using standard of care methods, Snare Tip Soft Coagulation (STSC) will be applied to the perimeter of the resection site before any clips are added. Snare Tip Soft Coagulation: STSC will be applied to the perimeter of the resection site	No Treatment Following polyp removal using standard of care methods, neither APC nor STSC will be applied to the perimeter of the resection site. Clips may be added at the discretion of the PI.
Overall Study STARTED	126	126	132
Overall Study COMPLETED	103	100	105
Overall Study NOT COMPLETED	23	26	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-resection Treatment of Large Colon Polyps

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Argon Plasma Coagulation n=126 Participants Following polyp removal using standard of care methods, Argon Plasma Coagulation (APC) will be applied to the perimeter of the resection site before any clips are added. Argon Plasma Coagulation: APC will be applied to the perimeter of the resection site	Snare Tip Soft Coagulation n=126 Participants Following polyp removal using standard of care methods, Snare Tip Soft Coagulation (STSC) will be applied to the perimeter of the resection site before any clips are added. Snare Tip Soft Coagulation: STSC will be applied to the perimeter of the resection site	No Treatment n=132 Participants Following polyp removal using standard of care methods, neither APC nor STSC will be applied to the perimeter of the resection site. Clips may be added at the discretion of the PI.	Total n=384 Participants Total of all reporting groups
Age, Continuous	65.4 Years STANDARD_DEVIATION 9.7 • n=5 Participants	66.0 Years STANDARD_DEVIATION 9.8 • n=7 Participants	65.5 Years STANDARD_DEVIATION 10.1 • n=5 Participants	65.6 Years STANDARD_DEVIATION 9.9 • n=4 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	55 Participants n=7 Participants	49 Participants n=5 Participants	162 Participants n=4 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	71 Participants n=7 Participants	83 Participants n=5 Participants	222 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	120 Participants n=5 Participants	124 Participants n=7 Participants	127 Participants n=5 Participants	371 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants	23 Participants n=4 Participants
Race (NIH/OMB) White	114 Participants n=5 Participants	117 Participants n=7 Participants	112 Participants n=5 Participants	343 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment United States	126 participants n=5 Participants	126 participants n=7 Participants	132 participants n=5 Participants	384 participants n=4 Participants
Boston Bowel Prep Score	9 scores on a scale n=5 Participants	9 scores on a scale n=7 Participants	9 scores on a scale n=5 Participants	9 scores on a scale n=4 Participants
Follow-up Colonoscopy Interval	6.4 Months n=5 Participants	6.4 Months n=7 Participants	6.3 Months n=5 Participants	6.4 Months n=4 Participants
Site AdventHealth Orlando	18 Participants n=5 Participants	16 Participants n=7 Participants	19 Participants n=5 Participants	53 Participants n=4 Participants
Site Dartmouth-Hitchcock Medical Center	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Site Indiana University	41 Participants n=5 Participants	42 Participants n=7 Participants	43 Participants n=5 Participants	126 Participants n=4 Participants
Site Johns Hopkins Hospital	14 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	43 Participants n=4 Participants
Site Mount Sinai Hospital	17 Participants n=5 Participants	17 Participants n=7 Participants	16 Participants n=5 Participants	50 Participants n=4 Participants
Site NYU Langone Medical Center	20 Participants n=5 Participants	21 Participants n=7 Participants	23 Participants n=5 Participants	64 Participants n=4 Participants
Site Penn State Health Milton S. Hershey Medical Center	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Site Sibley Memorial Hospital	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Site The University of Kansas Medical Center	10 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 day

Population: There were 103 patients that completed follow-up colonoscopy in the APC arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 108 lesions assessed for recurrence in the APC arm. For the same reason, there are 100 patients but 108 polyps in the STSC group and 105 patients but 112 polyps in the No Treatment group.

The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy

Outcome measures

Outcome measures
Measure	Argon Plasma Coagulation n=108 Polyps Following polyp removal using standard of care methods, Argon Plasma Coagulation (APC) will be applied to the perimeter of the resection site before any clips are added. Argon Plasma Coagulation: APC will be applied to the perimeter of the resection site	Snare Tip Soft Coagulation n=108 Polyps Following polyp removal using standard of care methods, Snare Tip Soft Coagulation (STSC) will be applied to the perimeter of the resection site before any clips are added. Snare Tip Soft Coagulation: STSC will be applied to the perimeter of the resection site	No Treatment n=112 Polyps Following polyp removal using standard of care methods, neither APC nor STSC will be applied to the perimeter of the resection site. Clips may be added at the discretion of the PI.
Recurrence	10 Polyps	5 Polyps	24 Polyps

PRIMARY outcome

Timeframe: 1 day

Population: There were 103 patients that completed follow-up colonoscopy in the APC arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 108 lesions assessed to check for recurrence in the APC arm. For the same reason, there are 100 patients but 108 polyps in the STSC group and 105 patients but 112 polyps in the No Treatment group.

Description of whether recurrence was visible during the follow-up procedure and confirmed by pathology, visible during the follow-up procedure but not confirmed by pathology, or not visible during the follow-up procedure but confirmed by pathology of biopsies taken.

Outcome measures

Outcome measures
Measure	Argon Plasma Coagulation n=108 Polyps Following polyp removal using standard of care methods, Argon Plasma Coagulation (APC) will be applied to the perimeter of the resection site before any clips are added. Argon Plasma Coagulation: APC will be applied to the perimeter of the resection site	Snare Tip Soft Coagulation n=108 Polyps Following polyp removal using standard of care methods, Snare Tip Soft Coagulation (STSC) will be applied to the perimeter of the resection site before any clips are added. Snare Tip Soft Coagulation: STSC will be applied to the perimeter of the resection site	No Treatment n=112 Polyps Following polyp removal using standard of care methods, neither APC nor STSC will be applied to the perimeter of the resection site. Clips may be added at the discretion of the PI.
Types of Recurrences Visible recurrence - Pathology verified	8 Polyps	5 Polyps	15 Polyps
Types of Recurrences Not visible recurrence - Pathology positive	2 Polyps	0 Polyps	8 Polyps
Types of Recurrences Visible recurrence - No pathology verification	0 Polyps	0 Polyps	1 Polyps

SECONDARY outcome

Timeframe: 1 day

Population: There were 126 patients in the APC arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 134 lesions included in the APC arm. For the same reason, there are 126 patients but 140 polyps in the STSC group and 132 patients but 140 polyps in the No Treatment group.

The time it takes to apply each respective treatment (APC or STSC) on the day of procedure

Outcome measures

Outcome measures
Measure	Argon Plasma Coagulation n=134 Polyps Following polyp removal using standard of care methods, Argon Plasma Coagulation (APC) will be applied to the perimeter of the resection site before any clips are added. Argon Plasma Coagulation: APC will be applied to the perimeter of the resection site	Snare Tip Soft Coagulation n=140 Polyps Following polyp removal using standard of care methods, Snare Tip Soft Coagulation (STSC) will be applied to the perimeter of the resection site before any clips are added. Snare Tip Soft Coagulation: STSC will be applied to the perimeter of the resection site	No Treatment n=140 Polyps Following polyp removal using standard of care methods, neither APC nor STSC will be applied to the perimeter of the resection site. Clips may be added at the discretion of the PI.
Time	4.08 Minutes Interval 2.75 to 6.4	3.35 Minutes Interval 1.97 to 6.0	NA Minutes The No Treatment arm did not receive margin treatment, so the time to apply margin treatment is not applicable for this group.

SECONDARY outcome

Timeframe: 1 day

Population: Number of patients that completed the follow-up to collect adverse event information.

To look at the number of complications for each randomization arm as assessed through a 30 day follow-up period

Outcome measures

Outcome measures
Measure	Argon Plasma Coagulation n=116 Participants Following polyp removal using standard of care methods, Argon Plasma Coagulation (APC) will be applied to the perimeter of the resection site before any clips are added. Argon Plasma Coagulation: APC will be applied to the perimeter of the resection site	Snare Tip Soft Coagulation n=122 Participants Following polyp removal using standard of care methods, Snare Tip Soft Coagulation (STSC) will be applied to the perimeter of the resection site before any clips are added. Snare Tip Soft Coagulation: STSC will be applied to the perimeter of the resection site	No Treatment n=123 Participants Following polyp removal using standard of care methods, neither APC nor STSC will be applied to the perimeter of the resection site. Clips may be added at the discretion of the PI.
Complications Delayed Bleeding	3 Adverse Events	4 Adverse Events	6 Adverse Events
Complications Perforation	0 Adverse Events	0 Adverse Events	0 Adverse Events
Complications Post Polypectomy Syndrome	0 Adverse Events	1 Adverse Events	1 Adverse Events
Complications Myocardial Infarction	1 Adverse Events	0 Adverse Events	0 Adverse Events
Complications Hospitalization	3 Adverse Events	5 Adverse Events	6 Adverse Events

Adverse Events

Argon Plasma Coagulation

Serious events: 7 serious events

Other events: 27 other events

Deaths: 1 deaths

Snare Tip Soft Coagulation

Serious events: 10 serious events

Other events: 30 other events

Deaths: 0 deaths

No Treatment

Serious events: 13 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Argon Plasma Coagulation n=126 participants at risk Following polyp removal using standard of care methods, Argon Plasma Coagulation (APC) will be applied to the perimeter of the resection site before any clips are added. Argon Plasma Coagulation: APC will be applied to the perimeter of the resection site	Snare Tip Soft Coagulation n=126 participants at risk Following polyp removal using standard of care methods, Snare Tip Soft Coagulation (STSC) will be applied to the perimeter of the resection site before any clips are added. Snare Tip Soft Coagulation: STSC will be applied to the perimeter of the resection site	No Treatment n=132 participants at risk Following polyp removal using standard of care methods, neither APC nor STSC will be applied to the perimeter of the resection site. Clips may be added at the discretion of the PI.
Injury, poisoning and procedural complications Delayed Bleeding	2.4% 3/126 • Number of events 3 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	3.2% 4/126 • Number of events 4 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	4.5% 6/132 • Number of events 6 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Injury, poisoning and procedural complications Post Polypectomy Syndrome	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.79% 1/126 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.76% 1/132 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Cardiac disorders Myocardial Infarction	0.79% 1/126 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/132 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Injury, poisoning and procedural complications Hospitalization	2.4% 3/126 • Number of events 3 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	4.0% 5/126 • Number of events 5 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	4.5% 6/132 • Number of events 6 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.

Other adverse events

Additional Information

Clinical Research Coordinator

Indiana University

Phone: 317-948-0724

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Argon Plasma Coagulation n=126 participants at risk Following polyp removal using standard of care methods, Argon Plasma Coagulation (APC) will be applied to the perimeter of the resection site before any clips are added. Argon Plasma Coagulation: APC will be applied to the perimeter of the resection site	Snare Tip Soft Coagulation n=126 participants at risk Following polyp removal using standard of care methods, Snare Tip Soft Coagulation (STSC) will be applied to the perimeter of the resection site before any clips are added. Snare Tip Soft Coagulation: STSC will be applied to the perimeter of the resection site	No Treatment n=132 participants at risk Following polyp removal using standard of care methods, neither APC nor STSC will be applied to the perimeter of the resection site. Clips may be added at the discretion of the PI.
Injury, poisoning and procedural complications Intraprocedural bleed during index polyp removal	10.3% 13/126 • Number of events 15 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	11.1% 14/126 • Number of events 14 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	12.1% 16/132 • Number of events 16 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Injury, poisoning and procedural complications Type 3 Muscle Injury	1.6% 2/126 • Number of events 2 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.79% 1/126 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.76% 1/132 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Injury, poisoning and procedural complications Pain	3.2% 4/126 • Number of events 4 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	9.5% 12/126 • Number of events 12 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	2.3% 3/132 • Number of events 3 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Injury, poisoning and procedural complications Delayed Bleeding	6.3% 8/126 • Number of events 8 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	6.3% 8/126 • Number of events 8 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	1.5% 2/132 • Number of events 2 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Injury, poisoning and procedural complications Bowel Movement Irregularity	1.6% 2/126 • Number of events 2 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.79% 1/126 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.76% 1/132 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Injury, poisoning and procedural complications Anesthesia Reaction	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	1.6% 2/126 • Number of events 2 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/132 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Respiratory, thoracic and mediastinal disorders pneumonia	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.79% 1/126 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.76% 1/132 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Vascular disorders Thrombosed AV fistula	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.79% 1/126 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/132 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Vascular disorders Blood clots	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.76% 1/132 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Hepatobiliary disorders Paracentesis	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.76% 1/132 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Psychiatric disorders Panic Attack	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.76% 1/132 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Blood and lymphatic system disorders Nose bleed	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.79% 1/126 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/132 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Respiratory, thoracic and mediastinal disorders Asthma	0.79% 1/126 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/132 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Renal and urinary disorders Kidney Stone	0.79% 1/126 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/132 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Injury, poisoning and procedural complications Motor Vehicle Accident	0.79% 1/126 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/132 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.
Injury, poisoning and procedural complications Post-Polypectomy Syndrome	0.79% 1/126 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.00% 0/126 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.	0.76% 1/132 • Number of events 1 • 1 month Patients were called approximately 30 days after their colonoscopy procedure.