Reducing Neoplasia Recurrence After Endoscopic Resection of Large Colorectal Polyps

NCT06271941 | Recruiting

• 1 other identifier: HAPC-RCT
• Study Type: interventional
• Target: 892
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Secondary Outcomes (5)

• Adverse event rates after EMR with STSC or h-APC

  4 years

• Technical success of STSC or h-APC

  4 years

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

  4 years

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

  4 years

• CRC occurrence during the 18-month follow-up period

  4 years

Other Outcomes (15)

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

  4 years

• EMR procedure time

  4 years

• STSC or h-APC ablation time

  4 years

Study Arms (2)

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

EXPERIMENTAL

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).

Procedure: Hybrid Argon Plasma Coagulation (h-APC)

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

ACTIVE COMPARATOR

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).

Procedure: Snare tip soft coagulation (STSC)

Interventions

Hybrid Argon Plasma Coagulation (h-APC) PROCEDURE

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.

Also known as: h-APC

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

Snare tip soft coagulation (STSC) PROCEDURE

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.

Also known as: STSC

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: July 19, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 12 months and ending 36 months following article publication.
• Access Criteria: Proposals should be directed to daniel.von.renteln.med@ssss.gouv.qc.ca . To gain access, data requestors will need to sign a data access agreement

Locations

CA (1)