N/A
N=40
Hybrid APC Assisted EMR for Large Colon Polyps
Colon Polyp · Colon Adenoma · Colon Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03390907 ↗Enrolled (actual)
40
Serious AEs
7.5%
Results posted
Nov 2021
Primary outcome: Primary: Percentage of Participants Having Complete Resection — 40 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hybrid APC (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Having Complete Resection |
40 | — |
| SECONDARY Measure of Within 30 Days of Procedure Adverse Events ( Post-polypectomy Bleeding and Post-polypectomy Syndrome) |
3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03390907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.