Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence

Summary

Endoscopic Mucosal Resection (EMR) is the current standard for effective endoscopic resection of such colon adenomas. If resection is possible in one piece (so-called "en bloc" resection) then recurrence rates are low. However, most non-pedunculated polyps \>2 cm are removed in pieces ("piece-meal" resection) which leads to disease recurrence rates between 12-30%. In the March 2019 issue of Gastroenterology Bourke et al. presented that post-EMR ablation of the resection margins using soft coagulation with the tip of a resection snare reduces adenoma recurrence to 5% compared to 21% recurrence found in the control group. Hybrid Argon Plasma Coagulation (h-APC) combines an ablation technique (APC) with the option for submucosal saline injection using a high-pressure water jet. The technique allows to lift of dysplastic epithelium thus creating a safety cushion under the mucosa is lifted with a saline injection and then to ablate larger areas more thoroughly and with a higher energy setting, with a low risk for side effects or complications.

The study hypothesis is that routine use of hybrid Argon Plasma Coagulation (h-APC) for ablation of the post-EMR resection margins and resection surface area will reduce post-EMR adenoma recurrence to 5% or lower.

Conditions

• Colorectal Cancer
• Polyp of Colon

Interventions

PROCEDURE

Hybrid Argon Plasma Coagulation and EMR procedure

Hybrid Argon Plasma Coagulation (h-APC) combines an ablation technique (APC) with the option for submucosal saline injection using a high-pressure water jet. The technique allows to lift dysplastic epithelium thus creating a safety cushion under the mucosa is lifted with a saline injection and then to ablate larger areas more thoroughly and with a higher energy setting, with a low risk for side effects or complications

Sponsors & Collaborators

• Penn State University

  collaborator OTHER

• University of Milan

  collaborator OTHER

• Erbe Elektromedizin GmbH

  collaborator INDUSTRY

• Unity Health Toronto

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• Centre hospitalier de l'Université de Montréal (CHUM)

  lead OTHER

Principal Investigators

• Daniel von Renteln, MD, PhD · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-26

Primary Completion

2024-12-13

Completion

2025-01-08

Countries

• Canada

Study Locations