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NCT Number: NCT02245854

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

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.

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Key information

Conditions

Polyp of Large Intestine Bleeding Colon Nos Polypectomy Tubular Adenoma Colonic Polyps Complications Hemorrhage Intestinal Polyps Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital, Rozzano, Milan, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exacto™

Device

Cold snare polypectomy

Primary outcomes

  1. Percentage of complete polyp removal

    Time frame: 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 outcomes

  1. Clinical success according to size

    Time frame: 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.

  2. Post-polypectomy bleeding rates

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Collaborators

  • Azienda Ospedaliero Universitaria Maggiore della Carita
  • San Gerardo Hospital

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 22, 2014
Registry last updated
Sep 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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