Recurrence
Conditions
Keywords
Argon Plasma Coagulation, Snare Tip Soft Coagulation, Recurrence rates
Brief summary
Patients who have provided informed consented and are scheduled to undergo endoscopic mucosal resection (EMR) of lesions 15mm and larger will be randomized to STSC (80 W, Effect 5) vs APC (preferred settings) vs No Treatment of the perimeter of the EMR site.
Detailed description
Data regarding polyp morphology, location & shape will be recorded in addition to procedure and treatment length. Injection fluid use and clipping will also be recorded in addition to any procedural complications. All randomized subjects will receive a 30-day post procedure follow-up phone call and be scheduled, as per the standard of care, to receive a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the rate of recurrence by endoscopic visualization of the EMR site at the first follow-up using endoscopic magnification and electronic chromoendoscopy, as well as systematic biopsy of the scars.
Interventions
DEVICEArgon Plasma Coagulation
APC will be applied to the perimeter of the resection site
STSC will be applied to the perimeter of the resection site
Sponsors
Erbe USA Incorporated
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized to Argon Plasma Coagulation vs Snare Tip Soft Coagulation vs no treatment
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 25 years and older * Ability to provide informed consent * Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion
Exclusion criteria
* Pedunculated lesions * Inflammatory bowel disease * Inability to provide informed consent * Lesions less than 15mm in largest dimension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence | 1 day | The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy |
| Types of Recurrences | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time | 1 day | The time it takes to apply each respective treatment (APC or STSC) on the day of procedure |
| Complications | 1 day | To look at the number of complications for each randomization arm as assessed through a 30 day follow-up period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 126 |
| 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 | 126 |
| 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. | 132 |
| Total | 384 |
Baseline characteristics
| Characteristic | Total | Argon Plasma Coagulation | Snare Tip Soft Coagulation | No Treatment |
|---|---|---|---|---|
| Age, Continuous | 65.6 Years STANDARD_DEVIATION 9.9 | 65.4 Years STANDARD_DEVIATION 9.7 | 66.0 Years STANDARD_DEVIATION 9.8 | 65.5 Years STANDARD_DEVIATION 10.1 |
| Boston Bowel Prep Score | 9 scores on a scale | 9 scores on a scale | 9 scores on a scale | 9 scores on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 6 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 371 Participants | 120 Participants | 124 Participants | 127 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Follow-up Colonoscopy Interval | 6.4 Months | 6.4 Months | 6.4 Months | 6.3 Months |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 8 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 2 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) White | 343 Participants | 114 Participants | 117 Participants | 112 Participants |
| Region of Enrollment United States | 384 participants | 126 participants | 126 participants | 132 participants |
| Sex: Female, Male Female | 162 Participants | 58 Participants | 55 Participants | 49 Participants |
| Sex: Female, Male Male | 222 Participants | 68 Participants | 71 Participants | 83 Participants |
| Site AdventHealth Orlando | 53 Participants | 18 Participants | 16 Participants | 19 Participants |
| Site Dartmouth-Hitchcock Medical Center | 9 Participants | 3 Participants | 4 Participants | 2 Participants |
| Site Indiana University | 126 Participants | 41 Participants | 42 Participants | 43 Participants |
| Site Johns Hopkins Hospital | 43 Participants | 14 Participants | 14 Participants | 15 Participants |
| Site Mount Sinai Hospital | 50 Participants | 17 Participants | 17 Participants | 16 Participants |
| Site NYU Langone Medical Center | 64 Participants | 20 Participants | 21 Participants | 23 Participants |
| Site Penn State Health Milton S. Hershey Medical Center | 4 Participants | 1 Participants | 1 Participants | 2 Participants |
| Site Sibley Memorial Hospital | 6 Participants | 2 Participants | 2 Participants | 2 Participants |
| Site The University of Kansas Medical Center | 29 Participants | 10 Participants | 9 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 126 | 0 / 126 | 0 / 132 |
| other Total, other adverse events | 27 / 126 | 30 / 126 | 24 / 132 |
| serious Total, serious adverse events | 7 / 126 | 10 / 126 | 13 / 132 |
Outcome results
Primary
Recurrence
The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Argon Plasma Coagulation | Recurrence | 10 Polyps |
| Snare Tip Soft Coagulation | Recurrence | 5 Polyps |
| No Treatment | Recurrence | 24 Polyps |
Primary
Types of Recurrences
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Argon Plasma Coagulation | Types of Recurrences | Not visible recurrence - Pathology positive | 2 Polyps |
| Argon Plasma Coagulation | Types of Recurrences | Visible recurrence - Pathology verified | 8 Polyps |
| Argon Plasma Coagulation | Types of Recurrences | Visible recurrence - No pathology verification | 0 Polyps |
| Snare Tip Soft Coagulation | Types of Recurrences | Not visible recurrence - Pathology positive | 0 Polyps |
| Snare Tip Soft Coagulation | Types of Recurrences | Visible recurrence - Pathology verified | 5 Polyps |
| Snare Tip Soft Coagulation | Types of Recurrences | Visible recurrence - No pathology verification | 0 Polyps |
| No Treatment | Types of Recurrences | Visible recurrence - Pathology verified | 15 Polyps |
| No Treatment | Types of Recurrences | Visible recurrence - No pathology verification | 1 Polyps |
| No Treatment | Types of Recurrences | Not visible recurrence - Pathology positive | 8 Polyps |
Secondary
Complications
To look at the number of complications for each randomization arm as assessed through a 30 day follow-up period
Time frame: 1 day
Population: Number of patients that completed the follow-up to collect adverse event information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Argon Plasma Coagulation | Complications | Delayed Bleeding | 3 Adverse Events |
| Argon Plasma Coagulation | Complications | Myocardial Infarction | 1 Adverse Events |
| Argon Plasma Coagulation | Complications | Post Polypectomy Syndrome | 0 Adverse Events |
| Argon Plasma Coagulation | Complications | Hospitalization | 3 Adverse Events |
| Argon Plasma Coagulation | Complications | Perforation | 0 Adverse Events |
| Snare Tip Soft Coagulation | Complications | Post Polypectomy Syndrome | 1 Adverse Events |
| Snare Tip Soft Coagulation | Complications | Delayed Bleeding | 4 Adverse Events |
| Snare Tip Soft Coagulation | Complications | Perforation | 0 Adverse Events |
| Snare Tip Soft Coagulation | Complications | Myocardial Infarction | 0 Adverse Events |
| Snare Tip Soft Coagulation | Complications | Hospitalization | 5 Adverse Events |
| No Treatment | Complications | Hospitalization | 6 Adverse Events |
| No Treatment | Complications | Myocardial Infarction | 0 Adverse Events |
| No Treatment | Complications | Delayed Bleeding | 6 Adverse Events |
| No Treatment | Complications | Post Polypectomy Syndrome | 1 Adverse Events |
| No Treatment | Complications | Perforation | 0 Adverse Events |
Secondary
Time
The time it takes to apply each respective treatment (APC or STSC) on the day of procedure
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Argon Plasma Coagulation | Time | 4.08 Minutes |
| Snare Tip Soft Coagulation | Time | 3.35 Minutes |
| No Treatment | Time | NA Minutes |