Prophylactic Double Thermal Ablation After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps

Trial Title: Prophylactic Double Thermal Ablation After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps

NCT ID: NCT06271941

Condition: Colorectal Cancer
Polyp of Colon

Conditions: Official terms:
Polyps
Colonic Polyps

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Hybrid Argon Plasma Coagulation (h-APC)
Description: 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.
Arm group label: Endoscopic Mucosal Resection (EMR)+Hybrid Argon Plasma Coagulation (h-APC)

Other name: h-APC

Intervention type: Procedure
Intervention name: Snare tip soft coagulation (STSC)
Description: 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.
Arm group label: Endoscopic Mucosal Resection (EMR) + Snare tip soft coagulation (STSC)

Other name: STSC

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. Recent studies have found that the use of hybrid argon plasma coagulation (h-APC) for the ablation of the margin and base of resection post-EMR could significantly reduce the recurrence rate, and complete closure of the post-EMR defect can prevent other adverse pre- and post-procedure outcomes such as bleeding. It is hypothesized that hypothesize that performing hybrid argon plasma coagulation (h-APC) margin and base ablation post-EMR for large (≥20mm) colorectal LSLs will demonstrate a lower recurrence rate compared to Snare Tip Soft Coagulation (STSC) margin ablation. It is also hypothesized that performing complete closure of the EMR defect will result in lower rates of adverse events compared to cases where no defect closure is performed.

Detailed description: This is a prospective, randomized controlled trial enrolling patients with non-pedunculated colorectal polyps ≥ 20mm who are referred for endoscopic mucosal resection (EMR). All primary EMRs will be randomized to either EMR with hybrid argon plasma coagulation (h-APC) ablation of the base and margins or EMR with Snare Tip Soft Coagulation (STSC) margin ablation groups. Additionally, each group will be randomized to either complete defect closure or not. 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 four 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. 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. The polypectomy site will be tattooed with submucosal injection of approximately 1-2cc of India ink (standard of care to mark lesions) to allow recognition of the polypectomy site during follow-up endoscopy. 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 at 20-30 days following the EMR will be conducted to assess possible adverse events. Follow-up 1: Surveillance colonoscopy at 6 months (± 2 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 (± 2 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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Centre Hospitalier de l'Université de Montréal

Address:
City: Montréal
Country: Canada

Status: Recruiting

Contact:
Last name: Julie Fleury

Phone: 514-890-8000

Phone ext: 30917
Email: julie.fleury.chum@ssss.gouv.qc.ca

Investigator:
Last name: Daniel Von Renteln, MD
Email: Principal Investigator

Start date: July 19, 2024

Completion date: April 1, 2028

Lead sponsor:
Agency: Centre hospitalier de l'Université de Montréal (CHUM)
Agency class: Other

Source: Centre hospitalier de l'Université de Montréal (CHUM)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06271941