4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence (h-APC EMR)

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

Study Description
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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 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
Actual Primary Completion Date : March 12, 2021
Actual Study Completion Date : March 12, 2021
Arms and Interventions
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
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
Layout table for eligibility information
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

Locations
Layout table for location information
Canada, Quebec
Centre Hospitalier Universitaire de Montréal (CHUM)
Montréal, Quebec, Canada
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
Tracking Information
First Submitted Date  ICMJE July 4, 2019
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date March 16, 2021
Actual Study Start Date  ICMJE August 26, 2019
Actual Primary Completion Date March 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence
Official Title  ICMJE Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Colorectal Cancer
  • Polyp of Colon
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Procedure: Hybrid Argon Plasma Coagulation and EMR procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2021) 		107
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2019) 		100
Actual Study Completion Date  ICMJE March 12, 2021
Actual Primary Completion Date March 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015765
Other Study ID Numbers  ICMJE h-APC EMR hybrid study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Responsible Party Centre hospitalier de l'Université de Montréal (CHUM)
Study Sponsor  ICMJE Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators  ICMJE
  • Penn State University
  • University of Milan
  • Erbe Elektromedizin GmbH
  • Dr John levenick
  • Dr Alessandro Repici
Investigators  ICMJE Not Provided
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

治疗案例

前沿医讯