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

Not Applicable

Completed

• Conditions: Polyp of Large Intestine; Colon Nos Polypectomy Tubular Adenoma; Colonic Polyps; Complications; Bleeding
• Interventions: Device: Exacto™

• Registration Number: NCT02245854
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2014-04
• Study Completion: 2014-08
• Status Verified: 2014-09
• Study First Submitted: 2014-09-01
• Study First Submitted QC: 2014-09-19
• Last Update Submitted: 2014-09-19
• Study First Posted: 2014-09-22
• Last Update Posted: 2014-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Colonic polyps	Exacto™	Exacto™

Primary Outcome Measures

Name	Time	Method
Percentage of complete polyp removal	One year	Clinical success, defined as absence of polyp tissue, either hyperplastic or adenomatous, on the margins of the polypectomy area after cold-polypectomy of subcentimetric polyps. Such assessment is performed on two biopsies performed on the polypectomy scar. The investigators will calculate the percentage (%) of complete and incomplete polypectomies with the new device.

Secondary Outcome Measures

Name	Time	Method
Clinical success according to size	One year	Clinical success (as defined in the primary end-point) according to the size class: diminutive (\<5 mm) and small (6-9 mm) polyps.
Post-polypectomy bleeding rates	One year	Post-polypectomy bleeding defined as any bleeding requiring immediate therapeutic endoscopic procedure (i.e. clipping, electrocautery) or delayed treatment, such as hospitalization or new endoscopic procedure.

Trial Locations

Locations (3)

San Gerardo Hospital; 🇮🇹 Monza, Italy

Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital; 🇮🇹 Rozzano, Milan, Italy

Azienda Ospedaliera "Maggiore della Carità"; 🇮🇹 Novara, Italy