Clinical trial NCT02245854: Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyp of Large Intestine
Colonic Polyps
Colon Nos Polypectomy Tubular Adenoma
Complications
Bleeding
Keywords: diminutive polyps
small polyps
cold snare polypectomy
complications
bleeding
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: San Gerardo Hospital
name: Azienda Ospedaliero Universitaria Maggiore della Carita
First posted: 2014-09-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of complete polyp removal
timeFrame: One year
Secondary outcomes:
measure: Clinical success according to size
timeFrame: One year
measure: Post-polypectomy bleeding rates
timeFrame: One year
Other outcomes:
Locations:
city: Monza
country: Italy
facility: San Gerardo Hospital
city: Novara
country: Italy
facility: Azienda Ospedaliera "Maggiore della Carità"
city: Rozzano, Milan
country: Italy
facility: Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
Study officials:
affiliation: Istituto Clinico Humanitas
name: Alessandro Repici, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.