Recruiting

Neoplasia Reduction

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT06271941

Conditions

Colorectal Cancer

Polyp of Colon

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hybrid Argon Plasma Coagulation (h-APC)

Snare tip soft coagulation (STSC)

Study Details

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.

Conditions

Colorectal Cancer

Polyp of Colon

Study ID

NCT06271941

Start date

Jul 19, 2024

Status verified date

Nov, 2024

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

892 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Endoscopic Mucosal Resection (EMR)+Hybrid Argon Plasma Coagulation (h-APC)

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).

active comparator: Endoscopic Mucosal Resection (EMR) + Snare tip soft coagulation (STSC)

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).

Interventions

Hybrid Argon Plasma Coagulation (h-APC)

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)

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.

Primary outcome measure

  • Recurrence after colorectal EMR between the h-APC and STSC methods [ Time Frame: 4 years ]

Central Contacts and Locations

Locations

Centre Hospitalier de l'Université de Montréal

Recruiting

Montréal, Quebec, Canada

Contacts

Julie Fleury

514-890-8000julie.fleury.chum@ssss.gouv.qc.ca

Principal Investigator:

Daniel Von Renteln, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Nov 25, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2024-11-25.