Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| San Gerardo Hospital | OTHER |
| Azienda Ospedaliero Universitaria Maggiore della Carita | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 (Exactoâ„¢) for polyp removal.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonic polyps | Experimental | Exactoâ„¢ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exactoâ„¢ | Device | Cold snare polypectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success according to size | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Repici, MD | Istituto Clinico Humanitas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital | Rozzano, Milan | Italy | 20089 | Italy | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22125197 | Background | 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. | |
| 21494037 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| San Gerardo Hospital |
| Monza |
| 20052 |
| Italy |
| Azienda Ospedaliera "Maggiore della Carità " | Novara | 28100 | Italy |
| 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. |
| 24125514 | 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. |
| 21689363 | 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. |
| 18691580 | 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. |
| 16281142 | 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. |
| 19866393 | 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. |
| 20430429 | 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. |
| D010335 | Pathologic Processes |