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Radio Frequency Ablation (RFA) and Argon Plasma Ablation (APC) for Colorectal Cancer (AE-Registry Trial)

N/A
Recruiting
Led By Daniel von Renteln, MD,PhD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-18 months
Awards & highlights

Summary

Advanced therapeutic endoscopy procedures are of increasing importance to provide minimal invasive treatment for GI diseases. The Centre Hospitalier de l'Université de Montréal as tertiary university center is dedicated to increase the availability of therapeutic endoscopy procedures for our population in Montreal and Quebec.

Eligible Conditions
  • Colorectal Cancer
  • Zenker Diverticulum
  • Colon Polyps

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess of the number of patients with severe bleeding complications (immediate or delayed)
Assess the efficacy of submucosal injectate
Assess the incidence of overall severe complications following the procedure
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Radio Frequency Ablation (RFA) and Argon Plasma Ablation (APC)Experimental Treatment1 Intervention
This is a mucosal thermo-destruction technique. It uses a generator that delivers a sinusoidal current of high frequency to a probe covered with bipolar electrodes in tight network ensuring a uniform diffusion of the thermal effect. The tissue penetration is superficial on 1mm, intended to eradicate the epithelium up to the muscularis mucosae. Circumferential or focal probes are used as a function of the length of the segment to be treated.
Group II: Per Oral Endoscopic Myotomy (POEM)Experimental Treatment1 Intervention
This technique allows a myotomy on the 8 cm of the lower esophagus extended on the gastric side of the cardia, totally endoscopically, after having approached and tunneled the esophageal submucosa. Less invasive, it gradually replaces the pneumatic dilatation and surgical myotomy of Heller. It requires a general anesthesia, an expert operator and a trained nursing team, ESD instruments, carbone dioxide insufflation.
Group III: Endoscopic mucosal resection (EMR)Experimental Treatment1 Intervention
It has become the standard treatment for superficial tumors of the gastrointestinal tract, either flat or sessile: precancerous lesions and superficial cancers with no or low ganglionic risk. The pre-injection of physiological serum detaches the lesion from the deep plane and allows, with great security, the resection of the mucosa, muscularis mucosae with part of the submucosa, whatever the size and location of the lesion. Compared to other techniques, it allows a histological analysis which dictates the subsequent conduct and the possible need for a complementary surgery.
Group IV: Endoscopic mucosal dissection (ESD)Experimental Treatment1 Intervention
This technique uses submucosal injection and special knives to make a peri-lesional circumferential incision, followed by dissection through the submucosal sub-lesion.

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Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
370 Previous Clinical Trials
129,315 Total Patients Enrolled
Daniel von Renteln, MD,PhDPrincipal InvestigatorCentre Hospitalier Universitaire de Montréal (CHUM)
~19 spots leftby Dec 2024
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