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The purpose of this study to evaluate and examine whether use of Hybrid Argon Plasma Coagulation (APC) as an adjunct to endoscopic mucosal resection (EMR) will reduce the risk of residual or recurrent neoplasia at 6 months. Hybrid APC is an existing FDA approved device used to assist with ablation of abnormal tissue anywhere in the GI tract.
Colon Cancer is a major disease that effects more than 1 million people per year globally. Adenomatous polyps have been identified as the main precursor leading to colorectal cancer. Colon cancer screening is the best way to detect and remove large, often asymptomatic polyps. Early detection and resection of these colorectal polyps can prevent the development of colon cancer. Endoscopic mucosal resection (EMR) is a technique used for resection of medium to large colon polyps. In this technique, fluid is injected into the submucosa creating a cushion between the mucosa and the muscularis propria. An electrocautery snare is then deployed to resect the polyp in a single (en-bloc) or multiple (piecemeal) pieces. Most polyps >2 cm are resected in piecemeal way. Although EMR is now considered standard of care with a successful resection rate of 85 % and low risk of complication (3-10% bleeding and 1% perforation), this technique has inherent deficiencies, especially piecemeal EMR. Recurrence rates following piecemeal EMR can be as high as 20%. Resection of scarred polyps using this technique is particularly challenging due to the non-lifting of the polyp. Endoscopic submucosal dissection (ESD) is an alternative approach that aims to remove non- pedunculated precancerous or cancerous lesions over 20 mm in one piece (en-bloc resection rate of 89.95% and lesion recurrence rate of 0.7%). However, due to its technical complexity and high complication risk (mainly bleeding and perforation, with complication rates approximately 8%), it is not the current standard of care and only performed by experts in the technique.
Hybrid Argon plasma coagulation (APC) is a new technique in which the endoscopist reinjects the submucosa with fluid to create a cushion (normal saline/ diluted adrenaline and /or sodium hyaluronate solution) to protect the muscle layer and then ablation is done using spray argon coagulation to treat any microscopic residual disease that is the seed for local recurrence. Previous studies have shown that this technique is a safe and easily applicable technique to complete resection for recurrent polyps after first EMR.
Investigators hypothesize that with Hybrid APC assisted EMR there will be a decrease in recurrence rate after 6 months and it will be more effective compared to the standard EMR procedure.
This is a pilot study in which patients with non-pedunculated large polyps ≥ 20mm undergoing endoscopic mucosal resection (EMR) will be recruited. Following standard EMR all patients will undergo adjuvant Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease. Resected polyps will be sent to the pathology laboratory where pathologist determine the final diagnosis of the polyps as per standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid APC | Experimental | Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid APC | Device | Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Having Complete Resection | The primary outcome of interest will be the percentage of participants having complete resection at 6 months. | 6 months post initial procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Within 30 Days of Procedure Adverse Events ( Post-polypectomy Bleeding and Post-polypectomy Syndrome) | The secondary outcome of interest will be measure of major adverse event rate, mainly post-polypectomy bleeding and post-polypectomy syndrome | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Levenick, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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Patients in Hershey Medical Center with a known ≥ 20mm polyp detected at a prior colonoscopy who were referred for colonoscopy procedure were identified as potential study participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hybrid APC | Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract. Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participant population was 10% (n=4) African American and 90% (n=36) with 100% (n=40) non-Hispanic/Latino population
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| ID | Title | Description |
|---|---|---|
| BG000 | Hybrid APC | Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract. Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease. |
| 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 | Percentage of Participants Having Complete Resection | The primary outcome of interest will be the percentage of participants having complete resection at 6 months. | Posted | Count of Participants | Participants | 6 months post initial procedure |
|
|
At 30 days following the initial resection, the research coordinator called each patient to assess for any signs of post-procedural adverse events.
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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 | Hybrid APC | Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract. Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Levenick | Penn State Milton S. Hershey Medical Center | 717-531-3834 | jlevenick@pennstatehealth.psu.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 | Feb 15, 2021 | Sep 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a pilot study design in which patients with non-pedunculated large polyps ≥ 20mm undergoing EMR will be recruited. Following standard EMR all patients will undergo adjuvant Hybrid Argon Plasma Coagulation (APC) of the base edges of the polypectomy site to fulgurate any potential microscopic residual disease.
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Following Standard EMR all patients will undergo adjuvant Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.
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| 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 | Count of Participants | Participants |
|
| Measurement of polyps in mm | Included polyps were a median size of 27 mm (IQR: 14.5 mm) and predominantly located in the ascending colon (31.8%), cecum (25.0%), and transverse colon (20.5%). | Mean | Standard Deviation | mm |
|
| Participants |
|
|
| Secondary | Measure of Within 30 Days of Procedure Adverse Events ( Post-polypectomy Bleeding and Post-polypectomy Syndrome) | The secondary outcome of interest will be measure of major adverse event rate, mainly post-polypectomy bleeding and post-polypectomy syndrome | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 40 |
| 3 |
| 40 |
| 0 |
| 40 |
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| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |