Hybrid APC Assisted EMR for Large Colon Polyps

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03390907
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Actual Duration (Months): 25
• Patients Per Site Per Month: 1.6

Study Details

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	N/A

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
• Actual Enrollment: 40 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.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: Sep 28, 2018
• Actual Primary Completion Date: Oct 27, 2020
• Actual Study Completion Date: Oct 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 Participants Having Complete Resection [6 months post initial procedure]

   The primary outcome of interest will be the percentage of participants having 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) [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

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 15, 2021

More Information

Publications

None provided.

• 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: Jan 4, 2018
• Last Update Posted: Nov 8, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by John M. Levenick, Assistant Professor of Medicine, Milton S. Hershey Medical Center: Colon polyp; EMR; Hybrid-APC; Laterally spreading tumor
• Additional relevant MeSH terms: Adenoma; Polyps; Colonic Polyps

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Hybrid APC
Arm/Group Description	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.
Period Title: Overall Study
STARTED	40
COMPLETED	40
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Hybrid APC
Arm/Group Description	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.
Overall Participants	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.6 (7.8)
Sex: Female, Male (Count of Participants)
Female	15 37.5%
Male	25 62.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	40 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 10%
White	36 90%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	40 100%
Measurement of polyps in mm (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	35.2 (12.6)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Having Complete Resection
Description	The primary outcome of interest will be the percentage of participants having complete resection at 6 months.
Time Frame	6 months post initial procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hybrid APC
Arm/Group Description	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. 0% of recurrence in 32 cases who completed post-procedure colonoscopy 6 month follow-up.
Measure Participants	40
Count of Participants [Participants]	40 100%

2. Secondary Outcome

Title	Measure of Within 30 Days of Procedure Adverse Events ( Post-polypectomy Bleeding and Post-polypectomy Syndrome)
Description	The secondary outcome of interest will be measure of major adverse event rate, mainly post-polypectomy bleeding and post-polypectomy syndrome
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hybrid APC
Arm/Group Description	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.
Measure Participants	40
Count of Participants [Participants]	3 7.5%

Adverse Events

Time Frame	At 30 days following the initial resection, the research coordinator called each patient to assess for any signs of post-procedural adverse events.
Arm/Group Title	Hybrid APC
Arm/Group Description	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.
All Cause Mortality
	Hybrid APC
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Serious Adverse Events
	Hybrid APC
	Affected / at Risk (%)	# Events
Total	3/40 (7.5%)
Gastrointestinal disorders
Bleeding	3/40 (7.5%)	3
Other (Not Including Serious) Adverse Events
	Hybrid APC
	Affected / at Risk (%)	# Events
Total	0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.