Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence

NCT04015765 | Completed

• 1 other identifier: CE.19.119
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Post-EMR recurrence at FU1

  The post-EMR recurrence at FU1 is defined as the rate of first follow-up colonoscopies with found adenomas.

  4 months (+- 2 months) after the index h-APC and EMR procedure

Secondary Outcomes (8)

• Complete adenoma eradication rates

  Within 1 year after the index EMR

• Incidence of complications

  14 days after the index EMR

• Severe bleeding complication rate

  14 days after the index EMR

• Perforation rate

  14 days after the index EMR

• Post-polypectomy syndrome incidence

  14 days after the index EMR

Study Arms (1)

Group treatment h-APC and EMR

EXPERIMENTAL

Standard endoscopic mucosal resection (EMR) technique will be used for primary removal of all polyps. Submucosal injection will be used to lift the polyp from the muscularis propria. Injection is used as per the current standard of care using a contrast agent and a lifting agent (e.g. NaCl 0.9% or Voluven). Snare electrocautery resection will be facilitated until complete visible removal of the complete polyp. Electrocautery snare technique is facilitated using standard microprocessor controlled electrocautery (e.g. ERBE VIO Endocut 3-1-6). Ablation of the margin after visibly complete removal of the polyp is routinely applied. For thermal ablation hybrid APC (Erbe Hybrid APC) will be applied using standard settings on the margin and resection base. Once resection and thermal ablation is considered complete the mucosal defect can be closed with clips or another preventative measure applied to reduce the risk for post-polypectomy bleeding.

Procedure: Hybrid Argon Plasma Coagulation and EMR procedure

Interventions

Hybrid Argon Plasma Coagulation and EMR procedure 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

Group treatment h-APC and EMR

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Ethnicity and race
• Patient referred for endoscopic resection of all colorectal polyps non-pedunculated equal or greater 20 mm
• Written informed consent

You may not qualify if:

• Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
• Previous partial EMR
• 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 (Boston bowel prep score ≤2)
• Target sign or perforation during initial EMR
• Need for ESD for complete resection prior to APC
• Pregnancy and breast-feeding.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Penn State University: collaborator
• University of Milan: collaborator
• Erbe Elektromedizin GmbH: collaborator
• Unity Health Toronto: collaborator
• University of British Columbia: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Montréal (CHUM)

Montreal, Quebec, Canada

Location

Related Publications (1)

• Motchum L, Levenick JM, Djinbachian R, Moyer MT, Bouchard S, Taghiakbari M, Repici A, Deslandres E, von Renteln D. EMR combined with hybrid argon plasma coagulation to prevent recurrence of large nonpedunculated colorectal polyps (with videos). Gastrointest Endosc. 2022 Nov;96(5):840-848.e2. doi: 10.1016/j.gie.2022.06.018. Epub 2022 Jun 18.

  PMID: 35724695 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel von Renteln, MD, PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 11, 2019
• Study Start: August 26, 2019
• Primary Completion: December 13, 2024
• Study Completion: January 8, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 12 months and ending 36 months following article publication.
• Access Criteria: Proposals should be directed to daniel.von.renteln.med@ssss.gouv.qc.ca . To gain access, data requestors will need to sign a data access agreement.

Locations

CA (1)