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Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence (h-APC EMR)

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ClinicalTrials.gov Identifier: NCT04015765
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : September 22, 2020
Sponsor:
Collaborators:
Penn State University
University of Milan
Erbe Elektromedizin GmbH
Dr John levenick
Dr Alessandro Repici
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Polyp of Colon Procedure: Hybrid Argon Plasma Coagulation and EMR procedure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Group treatment h-APC and EMR
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate adenoma recurrence rate [ Time Frame: 3-6 months after the index h-APC and EMR procedure ]
    The primary aim of the study is to evaluate adenoma recurrence rate after EMR and h-APC margin ablation at the first follow-up colonoscopy.

  2. Evaluate complete adenoma eradication rates [ Time Frame: Within 1 year after the inder EMR ]
    The secondary aims of the study are to evaluate complete adenoma eradication rates within 1 year after the index EMR when using EMR with margin ablation and ablating all recurrence found at the first follow up colonoscopy with h-APC.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015765


Contacts
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Contact: Daniel von Renteln, MD 5148908000 ext 30912 danielrenteln@gmail.com
Contact: Louise Merly 5148908000 ext 30916 louise.merly.chum@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Centre Hospitalier Universitaire de Montréal (CHUM) Recruiting
Montréal, Quebec, Canada
Contact: Daniel von Renteln, MD         
Contact: Louise Merly    5148908000 ext 30916    louise.merly.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Penn State University
University of Milan
Erbe Elektromedizin GmbH
Dr John levenick
Dr Alessandro Repici
More Information
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04015765    
Other Study ID Numbers: h-APC EMR hybrid study
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Adenoma
Recurrence
Colonic Polyps
Neoplasms
Disease Attributes
Pathologic Processes
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical