Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps

Istituto Clinico Humanitas

Status

Completed

Conditions

Colonic Polyps

Polyp of Large Intestine

Complications

Colon Nos Polypectomy Tubular Adenoma

Bleeding

Treatments

Device: Exacto™

Study type

Interventional

Funder types

Other

Identifiers

NCT02245854

E-Scope

Details and patient eligibility

About

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.

Enrollment

250 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All consecutive patients undergoing colonoscopy, with at least one and no more than 5 polyps <10 mm.
The patient is at satisfactory risk to undergo abdominal surgery.
The patient must understand and provide written consent for the procedure.

Exclusion criteria

Patients with inflammatory bowel disease.
Patients undergoing standard snare resection (with cautery) of polyps larger than 10 mm.
Patients with a personal history of polyposis syndrome.
Patients with suspected chronic stricture potentially precluding complete colonoscopy.
Patients with diverticulitis or toxic megacolon.
Patients with a history of radiation therapy to abdomen or pelvis.
Patients with a history of severe cardiovascular, pulmonary, liver or renal disease.
Personal history of coagulation disorders or use of anticoagulants/clopidogrel/aspirin/ticlopidine.
Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.