Colorectal Cancer Clinical Trial
— Cold-SnareOfficial title:
Improving Complete Resection Rates of 4-20mm Adenomas Using Cold Snare Polypectomy
NCT number | NCT03501849 |
Other study ID # | 17.296 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2018 |
Est. completion date | March 4, 2019 |
Verified date | April 2018 |
Source | Centre hospitalier de l'Université de Montréal (CHUM) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | March 4, 2019 |
Est. primary completion date | March 4, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier Universitaire de Montréal | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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