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

September 19, 2014 updated by: Michele Tedeschi, Istituto Clinico Humanitas

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Monza, Italy, 20052
        • San Gerardo Hospital
      • Novara, Italy, 28100
        • Azienda Ospedaliera "Maggiore della Carità"
      • Rozzano, Milan, Italy, 20089
        • Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colonic polyps
Exacto™
Device: Exacto™
Cold snare polypectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year
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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Collaborators

San Gerardo Hospital
Azienda Ospedaliero Universitaria Maggiore della Carita

Investigators

  • Principal Investigator: Alessandro Repici, MD, Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 1, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Estimate)

September 22, 2014

Last Update Submitted That Met QC Criteria

September 19, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-Scope

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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