Cold Snare Polypectomy (Cold-Snare)
Primary Purpose
Colorectal Cancer, Colon Adenoma
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Polypectomy using a cold snare
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring Cancer prevention, Cancer detection, Colonoscopy, Polypectomy, Cold Snare
Eligibility Criteria
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.
Sites / Locations
- Centre Hospitalier Universitaire de Montréal
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Polypectomy using a cold snare
Arm Description
Polypectomy by cold-snare technique
Outcomes
Primary Outcome Measures
Incomplete resection rate (in percentage)
Incomplete resection rate as defined by any adenomatous polyp tissue found in at least one marginal biopsies
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT03501849
First Posted
April 10, 2018
Last Updated
February 2, 2021
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT03501849
Brief Title
Cold Snare Polypectomy
Acronym
Cold-Snare
Official Title
Improving Complete Resection Rates of 4-20mm Adenomas Using Cold Snare Polypectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
March 4, 2019 (Actual)
Study Completion Date
March 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colon Adenoma
Keywords
Cancer prevention, Cancer detection, Colonoscopy, Polypectomy, Cold Snare
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polypectomy using a cold snare
Arm Type
Experimental
Arm Description
Polypectomy by cold-snare technique
Intervention Type
Device
Intervention Name(s)
Polypectomy using a cold snare
Intervention Description
Polypectomy by cold-snare technique
Primary Outcome Measure Information:
Title
Incomplete resection rate (in percentage)
Description
Incomplete resection rate as defined by any adenomatous polyp tissue found in at least one marginal biopsies
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of immediate bleeding complication (numerical)
Description
Defined as bleeding requiring endoscopic intervention either during colonoscopy/ polypectomy, or requiring an immediate second intervention such as surgery and/or hospital admission
Time Frame
2 years
Title
Number of delayed bleeding complications (numerical)
Description
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
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel von Renteln, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Montréal
City
Montréal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Cold Snare Polypectomy
We'll reach out to this number within 24 hrs