Bleeding Clinical Trial
Official title:
Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Subcentimetric Colorectal Polyps: the E-scope (Efficacy and Safety of COld PolypEctomy) Trial
Colorectal cancer is a major cause of morbidity and mortality in Western countries.
Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC
incidence and mortality.
Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel
perforation, so that a careful balance between efficacy and safety appears to be clinically
relevant.
Most of the polypectomies are performed for diminutive (<5 mm) or small (6-9 mm) lesions,
which represent over 90% of all the polyps.
To minimize the risk of complications when removing <10 mm polyps, cold-polypectomy
techniques - i.e. without electric current - by means of biopsy forceps or snare, have been
proposed.
Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of
electrocautery may result in an increased risk of bleeding. The safety of cold-snare
polypectomy has however been recently shown in controlled trials.
Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have
assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual
disease), and no studies have compared it to conventional polypectomy.
The investigators perform this study to assess both the efficacy and safety of a novel snare
(Exacto™) for polyp removal.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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