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Trial record 93 of 318 for:    colon cancer | ( Map: Canada )

Cold Snare Polypectomy in Combination With Optivista Imaging (Cold-Snare)

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ClinicalTrials.gov Identifier: NCT03501849
Recruitment Status : Completed
First Posted : April 18, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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 will 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 intestinal mucosa will be carefully examined using Optivista imaging 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colon Adenoma Device: Polypectomy using a cold snare Not Applicable

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. In addition, a sub mucosal injection of saline solution and Optivista imaging after polypectomy could help improve identification of adenoma remaining and further reduce incomplete resection rates of adenoma by colonoscopy.

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 will 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Complete Resection Rates of 4-20mm Adenomas Using Cold Snare Polypectomy With Submucosal Injection and Optivista Imaging
Actual Study Start Date : May 15, 2018
Actual Primary Completion Date : March 4, 2019
Actual Study Completion Date : March 4, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Polypectomy using a cold snare
Polypectomy by cold-snare technique and Optivista imaging
Device: Polypectomy using a cold snare
Polyp resection for all detected polyps of 4-20 mm using the cold-snare technique in combination with a sub mucosal injection of saline and Optivista imaging




Primary Outcome Measures :
  1. Incomplete resection rate (in percentage) [ Time Frame: 2 years ]
    Incomplete resection rate as defined by any adenomatous polyp tissue found in at least one marginal biopsies


Secondary Outcome Measures :
  1. Number of immediate bleeding complication (numerical) [ Time Frame: 2 years ]
    Defined as bleeding requiring endoscopic intervention either during colonoscopy/ polypectomy, or requiring an immediate second intervention such as surgery and/or hospital admission

  2. Number of delayed bleeding complications (numerical) [ Time Frame: 2 years ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501849


Locations
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Canada, Quebec
Centre Hospitalier Universitaire de Montréal
Montréal, Quebec, Canada
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Daniel von Renteln, MD, PhD Centre Hospitalier Universitaire de Montréal (CHUM)

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03501849     History of Changes
Other Study ID Numbers: 17.296
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Cancer prevention
Cancer detection
Colonoscopy
Polypectomy
Cold Snare
Optivista
Additional relevant MeSH terms:
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Adenoma
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type