Clinical trial NCT06271941: Reducing Neoplasia Recurrence After Endoscopic Resection of Large Colorectal Polyps
Official title: Reducing Neoplasia Recurrence After Endoscopic Resection of Large Colorectal Polyps
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Polyp of Colon
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 892
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: This trial is an open-label, two-arm, parallel-group, multicenter, randomized controlled superiority trial. Patients undergoing EMR will be randomly assigned in a 1:1 ratio to undergo additional STSC margin ablation (control group and current standard of care) or h-APC ablation of the margins and base (experimental group).

Patients will be enrolled in the study before the endoscopy procedure, or in the outpatient clinic.

Eligible patients who have consented to participate in the study will be asked to take a standard colonoscopy preparation regimen before their scheduled procedure.

EMR intervention will be performed for all eligible patients with a large laterally spreading lesions (LSLs) by expert endoscopists. Only if a polyp meets inclusion criteria, the study subject will be enrolled and randomized into one of these 2 groups:

* Group 1: EMR + h-APC margin and base thermal ablation
* Group 2: EMR + STSC of the margin

The standard EMR technique will be used for the primary removal of all polyps. Submucosal injection will be used to lift the polyp from the muscularis propria. Injection will be 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 will be facilitated using standard microprocessor-controlled electrocautery. If residual polyp tissue cannot be removed by a snare, other means such as cold snare (i.e., for small residual polyp tissue that cannot be engaged into standard snares) or avulsive methods will be used. Randomization will be performed after resection is complete and before thermal ablation. After the complete removal of the polyp, depending on the randomization group, h-APC or STSC techniques will be used for margin and base or only margin ablation of the post-EMR defect.

If multiple large polyps are found and removed, the study polyp will be marked with two tattoos 3 cm distal and 3 cm proximal to the lesion, to clearly identify the study polyp associated scar in the follow-up colonoscopy. Polyps will be sent to the pathology lab and evaluated according to standard practice by institutional pathologists. To determine the homogeneity and depth of h-APC margin ablation in the pathology lab, some ablated margins might be resected using the standard cold snare technique.

Telephone calls after 14 days following the EMR will be conducted to assess possible adverse events that occurred within the first 14 days after EMR.

Follow-up 1: Surveillance colonoscopy occurring 6 months after the EMR intervention for the assessment of recurrence (biopsy from the post-EMR site to be confirmed by pathology) following the intervention (h-APC) and the control (STSC) techniques.

Follow-up 2: Surveillance colonoscopy at 18 months (± 6 months) after the EMR intervention for the assessment of recurrence (biopsy from the post-EMR site to be confirmed by pathology) at FU1.

Patients with visible recurrence at the EMR site will undergo additional resection for complete eradication of recurrence. Patients with no visible but pathology-confirmed recurrence will be rescheduled for another colonoscopy with subsequent treatment of the post-EMR site and another follow-up colonoscopy for biopsies and confirmation of complete/incomplete eradication within 18 months after the initial EMR.

Eligibility criteria: Inclusion Criteria:

* adult ≥18 years old
* patients undergoing EMR for a large (≥20mm) colorectal LSL
* patients providing written and informed consent for study participation.

Exclusion Criteria:

* 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);
* pedunculated polyps (Paris class Ip, Isp);
* overt signs of deep submucosal invasive cancer (JNET 3);
* biopsy proven invasive carcinoma in a potential study polyp.
* Pregnant women

Primary outcomes:
measure: Recurrence after colorectal EMR between the h-APC and STSC methods
timeFrame: 4 years
Secondary outcomes:
measure: Adverse event rates after EMR with STSC or h-APC
timeFrame: 4 years
measure: Technical success of STSC or h-APC
timeFrame: 4 years
measure: Lesion recurrence at the 18-month follow-up after EMR with STSC or h-APC
timeFrame: 4 years
measure: High-grade dysplasia or colorectal cancer occurence after EMR during the 18-month follow-up period.
timeFrame: 4 years
measure: CRC occurrence during the 18-month follow-up period
timeFrame: 4 years
Other outcomes:
measure: Colonoscopies required to achieve lesion clearance after EMR with STSC or h-APC
timeFrame: 4 years
measure: EMR procedure time
timeFrame: 4 years
measure: STSC or h-APC ablation time
timeFrame: 4 years
measure: Loss to follow-up
timeFrame: 4 years
measure: Intestinal preservation 18 months after ablation
timeFrame: 4 years
measure: Clinically significant delayed bleeding in the proximal colon after EMR with STSC or h-APC
timeFrame: 14 days
measure: Clinically significant delayed bleeding in the distal colon after EMR with STSC or h-APC
timeFrame: 14 days
measure: Clinically significant delayed bleeding in the entire colon after EMR with STSC or h-APC
timeFrame: 14 days
measure: Delayed perforation after EMR with STSC or h-APC
timeFrame: 14 days
measure: Any delayed bleeding after EMR
timeFrame: 14 days
measure: Defect closure time
timeFrame: 4 years
measure: Technical success for complete defect closure
timeFrame: 4 years
measure: Costs associated with procedures
timeFrame: 4 years
measure: Factors associated with recurrence after colorectal EMR between the h-APC and STSC methods
timeFrame: 4 years
measure: Factors associated with adverse event rates after EMR with STSC or h-APC
timeFrame: 30 days
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
References: