Reducing Neoplasia Recurrence After Endoscopic Resection of Large Colorectal Polyps

ConditionsColorectal Cancer Polyp of Colon

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

Large (≥20mm) colorectal polyps often harbor areas of advanced neoplasia, making them immediate colorectal cancer (CRC) precursors. Such polyps have to be completely removed to prevent CRC and to avoid surgery and/or adjuvant therapy. The laterally spreading lesions (LSLs) are removed via endoscopic mucosal resection (EMR). However, recurrence is common. New techniques for LSL resection (hybrid argon plasma coagulation (h-APC) margin and base ablation) have shown a reduction in recurrence following the interventions.

We hypothesize that performing hybrid argon plasma coagulation (h-APC) margin and base ablation during EMR of large (≥20mm) colorectal LSLs will lead to lower rates of lesion recurrence compared to Snare tip soft coagulation (STSC) margin ablation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult ≥18 years old

patients undergoing EMR for a large (≥20mm) colorectal LSL

patients providing written and informed consent for study participation.

Disqualifiers

inflammatory bowel disease;

non-elective colonoscopy;

poor general health (American Society of Anesthesiologists classification >III);

coagulopathy or thrombocytopenia (international normalized ratio ≥1.5 or platelets <50 x 109/L);

Trial design

Design model

Parallel

Treatments tested in this trial

Hybrid Argon Plasma Coagulation (h-APC)
Procedure/Surgery
The 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 for the lifting of dysplastic epithelium, creating a cushion under the mucosa to facilitate the ablation of larger areas more thoroughly and with higher energy settings, while posing a low risk for side effects or complications.
Snare tip soft coagulation (STSC)
Procedure/Surgery
The Snare tip soft coagulation (STSC) involves using a snare to remove polyps, while simultaneously applying soft coagulation to the surrounding tissue using a specialized tip on the snare.

Treatment groups

892 Participants

are divided into 2 treatment groups

Group A: Endoscopic Mucosal Resection (EMR)+Hybrid Argon Plasma Coagulation (h-APC)Experimental treatment 1 intervention

Group B: Endoscopic Mucosal Resection (EMR) + Snare tip soft coagulation (STSC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Recurrence after colorectal EMR between the h-APC and STSC methods

Lesion recurrence at first follow-up after EMR of large (≥20mm) colorectal LSLs when performing STSC margin ablation or h-APC margin and base ablation. Defined by visual recurrence or pathology-confirmed hyperplastic, serrated or adenomatous histology of the same histology of the index lesion at the tattooed resection site on at least one of four random biopsies of resection scars. These will be evaluated from an intention to treat and per protocol standpoint.

Time frame

4 years

Secondary outcomes

Adverse event rates after EMR with STSC or h-APC

Adverse event rates after EMR of large (≥20mm) colorectal LSLs when performing EMR with STSC margin ablation or h-APC margin and base ablation. Defined as either a) delayed bleeding (defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention) or b) delayed perforation (defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract). These will be evaluated from an intention to treat and per protocol standpoint.

Time frame

4 years

Technical success of STSC or h-APC

Technical success of STSC or h-APC defined as achieving a complete uninterrupted ring ofcircumferential margin ablation for STSC and h-APC, without crossover to complete the margin ablation, and achieving 100% surface ablation of the resection base for h-APC.

Time frame

4 years

Lesion recurrence at the 18-month follow-up after EMR with STSC or h-APC

Time frame

4 years

High-grade dysplasia or colorectal cancer occurence after EMR during the 18-month follow-up period.

High-grade dysplasia or colorectal cancer occurence after EMR during the 18-month follow-up period at the resection site.

Time frame

4 years

Other outcomes

Colonoscopies required to achieve lesion clearance after EMR with STSC or h-APC

Colonoscopies required to achieve lesion clearance, defined as no histologic recurrence at the resection scar on follow-up.

Time frame

4 years

EMR procedure time

EMR procedure time with STSC or h-APC

Time frame

4 years

STSC or h-APC ablation time

Time frame

4 years

Loss to follow-up

Time frame

4 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Source ClinicalTrials.gov

Apply now