Cold Snare Polypectomy (Cold-Snare)

Improving Complete Resection Rates of 4-20mm Adenomas Using Cold Snare Polypectomy

During colonoscopy, the endoscopist will document prospectively all polyps detected and note the size, location and morphology. Polyps of 4-20 mm will be removed only in accordance with the method the cold snare. Afterwards, the remaining tissues could be observed with an imaging technology called Optivista with an injection of 10-50 ml of saline solution (if required) to improve visibility of the tissues. The endoscopist will continue to remove the remaining polyp tissue (with a snare or forceps) until there are no more visible polyp tissues. Biopsies from the polyp resection site will be sent to the laboratory for analysis to confirm the complete resection.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colon Adenoma
• Intervention / Treatment: Device: Polypectomy using a cold snare

Detailed Description

Colorectal cancer (CRC) is a major global disease affecting more than 1 million people worldwide and the majority of colon cancers develop from adenomas. The purpose of endoscopic cancer prevention is the detection and removal of these precancerous adenomatous polyps. However, polyps between 4-20 mm are incompletely eliminated in about 10% of cases, which is one of the main risk factors for patients to develop post-colonoscopy cancers. The polypectomy with cold snare showed promising results for complete adenoma resection rates for polyps up to 9 mm.

The hypotheses is that polypectomy with cold snare could be a standard approach for polyps up to 20 mm and could improve the rates of complete resection of the adenoma.

All eligible patients to undergo colonoscopy will be considered for the project.

Patients will be identified from the colonoscopy appointment lists at the CHUM. During colonoscopy, the endoscopist will document prospectively all polyps detected and note the size, location and morphology. All polyps will be removed during the procedure and will be sent to the laboratory as recommended in current clinical practice. Polyps of 4-20 mm will be removed only in accordance with the method the cold snare. Afterwards, the remaining tissues could be observed with an imaging technology called Optivista with an injection of 10-50 ml of saline solution (ir required) to improve visibility of the tissues. Optivista is an imaging technique based that uses a light filter for endoscopic optical diagnosis where light of specific blue and green wavelengths is used to enhance the surface and vascular patterns of the polyp surface mucosa. The intestinal mucosa will be carefully examined and the endoscopist will continue to remove the remaining polyp tissue (with a snare or forceps) until there are no more visible polyp tissues. Biopsies from the polyp resection site will be sent to the laboratory for analysis to confirm the complete resection.

Telephone follow-up will be done 14 days after the procedure to report possible side effects occurred.

The rate of incomplete resection of all adenomatous polyps resected in the cold snare will be determinate after completion of this project. The confidence interval will first be calculated using the exact confidence limits of Clopper-Pearson, considering all adenomatous polyps. An additional analysis will also be performed with a model of estimation equations (GEE) based on the binomial distribution to obtain standard errors taking into account the correlation with the patient.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Centre hospitalier universitaire de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed informed consent
• Age 45 to 80 years
• Indication for full colonoscopy

Exclusion Criteria:

• Known inflammatory bowel disease
• Active colitis
• Coagulopathy
• Familial polyposis syndrome
• Poor general health defined as an ASA class > 3
• Emergency colonoscopies defined as patients with evidence of hemodynamic instability and/or ongoing active GI bleeding and/or intensive care requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polypectomy using a cold snare; Polypectomy by cold-snare technique	Device: Polypectomy using a cold snare; Polypectomy by cold-snare technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incomplete resection rate (in percentage)	Incomplete resection rate as defined by any adenomatous polyp tissue found in at least one marginal biopsies	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of immediate bleeding complication (numerical)	Defined as bleeding requiring endoscopic intervention either during colonoscopy/ polypectomy, or requiring an immediate second intervention such as surgery and/or hospital admission	2 years
Number of delayed bleeding complications (numerical)	Defined as bleeding after the end of the initial procedure until 30 days later, requiring a second endoscopic intervention or another intervention such as surgery and/or hospital admission	2 years

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Daniel von Renteln, MD, PhD, Centre Hospitalier Universitaire de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): March 4, 2019
• Study Completion (Actual): March 4, 2019

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Colonoscopy; Polypectomy; Cancer prevention; Cold Snare; Cancer detection
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 17.296

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No