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| Name | Class |
|---|---|
| Erbe USA Incorporated | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Argon Plasma Coagulation | Experimental | 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. |
|
| Snare Tip Soft Coagulation | Experimental | 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. |
|
| No treatment | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Argon Plasma Coagulation | Device | APC will be applied to the perimeter of the resection site |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy | 1 day |
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Time | The time it takes to apply each respective treatment (APC or STSC) on the day of procedure | 1 day |
| Complications | To look at the number of complications for each randomization arm as assessed through a 30 day follow-up period |
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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 |
|---|---|---|---|---|---|---|
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States | ||
| AdventHealth Orlando |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27271329 | Background | Zhan T, Hielscher T, Hahn F, Hauf C, Betge J, Ebert MP, Belle S. Risk Factors for Local Recurrence of Large, Flat Colorectal Polyps after Endoscopic Mucosal Resection. Digestion. 2016;93(4):311-7. doi: 10.1159/000446364. Epub 2016 Jun 7. | |
| 11868011 | Background | Brooker JC, Saunders BP, Shah SG, Thapar CJ, Suzuki N, Williams CB. Treatment with argon plasma coagulation reduces recurrence after piecemeal resection of large sessile colonic polyps: a randomized trial and recommendations. Gastrointest Endosc. 2002 Mar;55(3):371-5. doi: 10.1067/mge.2002.121597. |
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De-identified data can be shared in the future upon request.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| 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 | Recurrence | The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy | 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. | 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 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delayed Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraprocedural bleed during index polyp removal | Injury, poisoning and procedural complications | Systematic Assessment |
Imbalance in patient recruitment among sites. We included polyps resected en bloc & 15-19mm polyps. Whether margin treatment is beneficial after en bloc resection or removal of 15-19 mm polyps is unknown.
Endoscopists couldn't be blinded to randomized treatment. Dropout rate was higher than expected, so planned power was slightly reduced.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | 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 | Sep 3, 2020 | Sep 1, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D057908 | Argon Plasma Coagulation |
| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| D002425 | Cautery |
| D013812 | Therapeutics |
| D006489 | Hemostatic Techniques |
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Patients will be randomized to Argon Plasma Coagulation vs Snare Tip Soft Coagulation vs no treatment
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| Snare Tip Soft Coagulation | Device | STSC will be applied to the perimeter of the resection site |
|
| 1 day |
| Orlando |
| Florida |
| 32803 |
| United States |
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| Spring Mill Medical Center | Indianapolis | Indiana | 46290 | United States |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| 29020690 | Background | Tate DJ, Bahin FF, Desomer L, Sidhu M, Gupta V, Bourke MJ. Cold-forceps avulsion with adjuvant snare-tip soft coagulation (CAST) is an effective and safe strategy for the management of non-lifting large laterally spreading colonic lesions. Endoscopy. 2018 Jan;50(1):52-62. doi: 10.1055/s-0043-119215. Epub 2017 Oct 11. |
| 37871841 | Derived | Rex DK, Haber GB, Khashab M, Rastogi A, Hasan MK, DiMaio CJ, Kumta NA, Nagula S, Gordon S, Al-Kawas F, Waye JD, Razjouyan H, Dye CE, Moyer MT, Shultz J, Lahr RE, Yuen PYS, Dixon R, Boyd L, Pohl H. Snare Tip Soft Coagulation vs Argon Plasma Coagulation vs No Margin Treatment After Large Nonpedunculated Colorectal Polyp Resection: a Randomized Trial. Clin Gastroenterol Hepatol. 2024 Mar;22(3):552-561.e4. doi: 10.1016/j.cgh.2023.09.041. Epub 2023 Oct 21. |
| 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 |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Boston Bowel Prep Score | Boston Bowel Preparation Score for patients. The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality. | Median | Inter-Quartile Range | scores on a scale |
|
| Follow-up Colonoscopy Interval | Median | Inter-Quartile Range | Months |
|
| Site | Count of Participants | Participants |
|
| OG001 | 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 |
| OG002 | 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. |
|
|
| 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. | 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. | Posted | Count of Units | Polyps | 1 day | Polyps | Polyps |
|
|
|
| Secondary | Time | The time it takes to apply each respective treatment (APC or STSC) on the day of procedure | 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. | Posted | Median | Inter-Quartile Range | Minutes | 1 day | Polyps | Polyps |
|
|
|
| Secondary | Complications | To look at the number of complications for each randomization arm as assessed through a 30 day follow-up period | Number of patients that completed the follow-up to collect adverse event information. | Posted | Number | Adverse Events | 1 day |
|
|
|
| 1 |
| 126 |
| 7 |
| 126 |
| 27 |
| 126 |
| EG001 | 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 | 0 | 126 | 10 | 126 | 30 | 126 |
| EG002 | 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. | 0 | 132 | 13 | 132 | 24 | 132 |
| Post Polypectomy Syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Hospitalization | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Type 3 Muscle Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Delayed Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bowel Movement Irregularity | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Anesthesia Reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Thrombosed AV fistula | Vascular disorders | Systematic Assessment |
|
| Blood clots | Vascular disorders | Systematic Assessment |
|
| Paracentesis | Hepatobiliary disorders | Systematic Assessment |
|
| Panic Attack | Psychiatric disorders | Systematic Assessment |
|
| Nose bleed | Blood and lymphatic system disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Kidney Stone | Renal and urinary disorders | Systematic Assessment |
|
| Motor Vehicle Accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Post-Polypectomy Syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D055011 |
| Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D006488 | Hemostasis, Surgical |
|
| Visible recurrence - No pathology verification |
|
| Title | Measurements |
|---|---|
|
| Post Polypectomy Syndrome |
|
| Myocardial Infarction |
|
| Hospitalization |
|