Hybrid APC Assisted EMR for Large Colon Polyps

• ClinicalTrials.gov Identifier: NCT03390907
• Recruitment Status: Completed
• First Posted: January 4, 2018
• Last Update Posted: December 24, 2020
• Sponsor: Milton S. Hershey Medical Center
• Information provided by (Responsible Party): John M. Levenick, Milton S. Hershey Medical Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Colon Polyp; Colon Adenoma; Colon Cancer	Device: Hybrid APC	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Hybrid APC Assisted EMR for Large Colon Polyps to Reduce Local Recurrence : A Prospective Data Collection Study
• Actual Study Start Date: September 28, 2018
• Actual Primary Completion Date: October 27, 2020
• Actual Study Completion Date: October 27, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Hybrid APC; Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract.	Device: 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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of complete resection [ Time Frame: 6 months post initial procedure ]
   The primary outcome of interest will be the percentage of complete resection at 6 months.

Secondary Outcome Measures :

1. Measure of within 30 days of procedure adverse events ( post-polypectomy bleeding and post-polypectomy syndrome) [ Time Frame: 30 days ]
   The secondary outcome of interest will be measure of major adverse event rate, mainly post-polypectomy bleeding and post-polypectomy syndrome

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Adult patient aged ≥18 and ≤89 of any gender, ethnicity and race referred to endoscopy for resection of large colon polyps
• Patients with a ≥20mm colon non-pedunculated polyp
• Ability to give written informed consent

Exclusion Criteria:

• Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
• Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
• Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
• Patients with inflammatory bowel disease
• Patients who are receiving an emergency colonoscopy
• Poor general health (ASA class>3)
• Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
• Poor bowel preparation
• Target sign or perforation during initial EMR
• Need for ESD for complete resection prior to APC
• Pregnancy

Contacts and Locations

Locations

United States, Pennsylvania

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Sponsors and Collaborators

Milton S. Hershey Medical Center

Investigators

• Principal Investigator: John Levenick, MD; Milton S. Hershey Medical Center

More Information

• Responsible Party: John M. Levenick, Assistant Professor of Medicine, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT03390907
• Other Study ID Numbers: STUDY00008877
• First Posted: January 4, 2018
• Last Update Posted: December 24, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by John M. Levenick, Milton S. Hershey Medical Center:

Colon polyp; EMR; Hybrid-APC; Laterally spreading tumor

Additional relevant MeSH terms:

Adenoma; Polyps; Colonic Polyps; Neoplasms; Pathological Conditions, Anatomical; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Intestinal Polyps