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Double Thermal Ablation for Colon Polyps (ABLATION Trial)

N/A
Recruiting
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing EMR for a large (≥20mm) colorectal LSL
Be older than 18 years old
Must not have
Non-elective colonoscopy
History of inflammatory bowel disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Summary

This trial aims to compare the recurrence rates of large colorectal polyps after endoscopic mucosal resection (EMR) using hybrid argon plasma coagulation (h-APC) versus

Who is the study for?
This trial is for adults over 18 who are having a specific type of colonoscopy to remove large colorectal polyps. They must be in good health, not have inflammatory bowel disease or blood clotting problems, and can't have cancerous or pedunculated polyps.
What is being tested?
The study compares two techniques after removing large colorectal polyps: h-APC (a kind of electric coagulation) versus STSC (another coagulation method). It also looks at whether sealing the removal site affects recovery.
What are the potential side effects?
Potential side effects may include discomfort at the ablation site, bleeding, infection risk from the procedure, and possible complications from tissue closure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having a procedure to remove a large growth in my colon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for an urgent colonoscopy.
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I have a history of inflammatory bowel disease.
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My overall health is considered poor by medical standards.
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My cancer shows clear signs of deep growth into the layers of my gut.
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My biopsy shows cancer in a polyp.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrence after colorectal EMR between the h-APC and STSC methods
Secondary study objectives
Adverse event rates after EMR with STSC or h-APC
High-grade dysplasia or colorectal cancer occurence after EMR during the 18-month follow-up period.
Lesion recurrence at the 18-month follow-up after EMR with STSC or h-APC
+1 more
Other study objectives
Clinically significant delayed bleeding after EMR with STSC or h-APC
Clinically significant delayed bleeding in the proximal colon after EMR with STSC or h-APC
Delayed perforation after EMR with STSC or h-APC
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Endoscopic Mucosal Resection (EMR)+Hybrid Argon Plasma Coagulation (h-APC)Experimental Treatment1 Intervention
Standard endoscopic mucosal resection (EMR) technique will be used for the primary removal of all polyps, utilizing submucosal injection. Electrocautery snare technique will be facilitated using standard microprocessor-controlled electrocautery (e.g., ERBE VIO Endocut 3-1-6). Ablation of the margin and base of the polypectomy site will be performed using Hybrid Argon Plasma Coagulation (h-APC, Erbe Hybrid APC).
Group II: Endoscopic Mucosal Resection (EMR) + Snare tip soft coagulation (STSC)Active Control1 Intervention
Standard endoscopic mucosal resection (EMR) technique will be used for the primary removal of all polyps, utilizing submucosal injection. Electrocautery snare technique will be facilitated using standard microprocessor-controlled electrocautery (e.g., ERBE VIO Endocut 3-1-6). Ablation of the margin of the polypectomy site will be performed using Snare tip soft coagulation (STSC).

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
372 Previous Clinical Trials
130,139 Total Patients Enrolled
~595 spots leftby Oct 2027
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