Hybrid APC Assisted EMR for Large Colon Polyps



Status:Recruiting
Conditions:Colorectal Cancer, Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - 89
Updated:3/7/2019
Start Date:September 28, 2018
End Date:June 1, 2020
Contact:John M Levenick, MD
Email:jlevenick@pennstatehealth.psu.edu
Phone:717-531-3834

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Hybrid APC Assisted EMR for Large Colon Polyps to Reduce Local Recurrence : A Prospective Data Collection Study

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.

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
We found this trial at
1
site
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Phone: 717-531-3834
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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mi
from
Hershey, PA
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