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

NCT02245854 | Completed DMC

• 1 other identifier: E-Scope
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

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.

Conditions

Polyp of Large Intestine; Colonic Polyps; Colon Nos Polypectomy Tubular Adenoma; Complications; Bleeding

Keywords

diminutive polyps; small polyps; cold snare polypectomy; complications; bleeding

Outcome Measures

Primary Outcomes (1)

• Percentage of complete polyp removal

  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 Outcomes (2)

• Clinical success according to size

  One year

• Post-polypectomy bleeding rates

  One year

Study Arms (1)

Colonic polyps

EXPERIMENTAL

Exacto™

Device: Exacto™

Interventions

Exacto™ DEVICE

Cold snare polypectomy

Colonic polyps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• San Gerardo Hospital: collaborator
• Azienda Ospedaliero Universitaria Maggiore della Carita: collaborator

Study Sites (3)

Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital

Rozzano, Milan, Italy, 20089, Italy

Location

San Gerardo Hospital

Monza, 20052, Italy

Location

Azienda Ospedaliera "Maggiore della Carità"

Novara, 28100, Italy

Location

Related Publications (8)

• Repici A, Hassan C, Vitetta E, Ferrara E, Manes G, Gullotti G, Princiotta A, Dulbecco P, Gaffuri N, Bettoni E, Pagano N, Rando G, Strangio G, Carlino A, Romeo F, de Paula Pessoa Ferreira D, Zullo A, Ridola L, Malesci A. Safety of cold polypectomy for <10mm polyps at colonoscopy: a prospective multicenter study. Endoscopy. 2012 Jan;44(1):27-31. doi: 10.1055/s-0031-1291387. Epub 2011 Nov 28.

  PMID: 22125197 BACKGROUND

• Ichise Y, Horiuchi A, Nakayama Y, Tanaka N. Prospective randomized comparison of cold snare polypectomy and conventional polypectomy for small colorectal polyps. Digestion. 2011;84(1):78-81. doi: 10.1159/000323959. Epub 2011 Apr 14.

  PMID: 21494037 BACKGROUND

• Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.

  PMID: 24125514 BACKGROUND

• Paspatis GA, Tribonias G, Konstantinidis K, Theodoropoulou A, Vardas E, Voudoukis E, Manolaraki MM, Chainaki I, Chlouverakis G. A prospective randomized comparison of cold vs hot snare polypectomy in the occurrence of postpolypectomy bleeding in small colonic polyps. Colorectal Dis. 2011 Oct;13(10):e345-8. doi: 10.1111/j.1463-1318.2011.02696.x.

  PMID: 21689363 BACKGROUND

• Lieberman D, Moravec M, Holub J, Michaels L, Eisen G. Polyp size and advanced histology in patients undergoing colonoscopy screening: implications for CT colonography. Gastroenterology. 2008 Oct;135(4):1100-5. doi: 10.1053/j.gastro.2008.06.083. Epub 2008 Jul 3.

  PMID: 18691580 BACKGROUND

• Heldwein W, Dollhopf M, Rosch T, Meining A, Schmidtsdorff G, Hasford J, Hermanek P, Burlefinger R, Birkner B, Schmitt W; Munich Gastroenterology Group. The Munich Polypectomy Study (MUPS): prospective analysis of complications and risk factors in 4000 colonic snare polypectomies. Endoscopy. 2005 Nov;37(11):1116-22. doi: 10.1055/s-2005-870512.

  PMID: 16281142 BACKGROUND

• Panteris V, Haringsma J, Kuipers EJ. Colonoscopy perforation rate, mechanisms and outcome: from diagnostic to therapeutic colonoscopy. Endoscopy. 2009 Nov;41(11):941-51. doi: 10.1055/s-0029-1215179. Epub 2009 Oct 28.

  PMID: 19866393 BACKGROUND

• Atkin WS, Edwards R, Kralj-Hans I, Wooldrage K, Hart AR, Northover JM, Parkin DM, Wardle J, Duffy SW, Cuzick J; UK Flexible Sigmoidoscopy Trial Investigators. Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial. Lancet. 2010 May 8;375(9726):1624-33. doi: 10.1016/S0140-6736(10)60551-X. Epub 2010 Apr 27.

  PMID: 20430429 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps; Hemorrhage

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Alessandro Repici, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible of the Clinical Research Project

Study Record Dates

• First Submitted: September 1, 2014
• First Posted: September 22, 2014
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 22, 2014

Record last verified: 2014-09

Locations

IT (3)