Cold Snare,Hot Snare and APC Polypectomy for the Complete Removal of Small Left Sided Colon Polyps

NCT02479893 | Completed DMC

• 1 other identifier: 80/30-04-2015
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Given the limited existing data regarding the advantages and limitations of the existing techniques in the removal of colonic polyps the investigators designed a prospective study in order to compare cold snare vs hot snare vs argon plasma coagulation for the compete removal of colonic polyps of the left colon up to a diameter of 0.8cm.

Conditions

Colonic Polyps

Keywords

cold snare polypectomy; APC; hot snare polypectomy

Outcome Measures

Primary Outcomes (1)

• Complete removal of colonic polyps

  The resections margin of the polyp was isolated from the rest of the polyp,stained with black and examined through multiple histological sections in order to certify that no dysplastic cells were traced upon the resection margin.Since all adenoma cases exhibited low grade epithelial dysplasia, as positive margin was considered the presence of dysplastic cell exactly upon the resection margin/black ink.

  at 6 months after polypectomy

Study Arms (3)

cold snare polypectomy

CSP: In this group polyps will be removed with the cold snare polypectomy technique, as a single piece. Additionally, a 1-2mm of normal tissue around the small polyp will also be ensnared in the CSP.

Procedure: polypectomy

hot snare polypectomy

HSP: In this group polyps will be removed with the hot snare polypectomy technique as a single piece with a electrosurgical snare and monopolar current with a setting of 30-35 W in the endocut function.

Procedure: polypectomy

APC polyp destruction-polypectomy

APC: In APC group polyps will be cauterized by application of high power argon plasma coagulation on small waves at 50-60W and flow at 2lt/min,as result the polyp destruction.

Procedure: polypectomy

Interventions

polypectomy PROCEDURE

Polyps size up to 0.8 cm will removed from the left colon.Re examination in 6 months period with biopsy from the scar of polypectomy.

Also known as: sigmoidoscopy, colonoscopy

APC polyp destruction-polypectomy; cold snare polypectomy; hot snare polypectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with colonic left sided small polyps

You may qualify if:

• All consecutive patients with colorectal polyps of the left colon (up to the splenic flexure) with a diameter of 0.3-0.8cm.

You may not qualify if:

• The study excluded patients with a history of familial polyposis (FAP), Gardner's syndrome, Peutz-Jeghers syndrome, patients with colon Cancer as well as patients with idiopathic inflammatory bowel disease (IBD).

Sponsors & Collaborators

• Evangelismos Hospital: lead
• Attikon Hospital: collaborator

Study Sites (1)

Evangelismos Hospital

Athens, Attica, 10676, Greece

Location

Related Publications (8)

• Schneider R, Goldman AB, Insall JN. Knee prostheses. Semin Roentgenol. 1986 Jan;21(1):29-46. doi: 10.1016/0037-198x(86)90007-6. No abstract available.

  PMID: 3513321 BACKGROUND

• Tolliver KA, Rex DK. Colonoscopic polypectomy. Gastroenterol Clin North Am. 2008 Mar;37(1):229-51, ix. doi: 10.1016/j.gtc.2007.12.009.

  PMID: 18313548 BACKGROUND

• Uno Y, Obara K, Zheng P, Miura S, Odagiri A, Sakamoto J, Munakata A. Cold snare excision is a safe method for diminutive colorectal polyps. Tohoku J Exp Med. 1997 Dec;183(4):243-9. doi: 10.1620/tjem.183.243.

  PMID: 9549824 BACKGROUND

• Winawer SJ, Zauber AG, Fletcher RH, Stillman JS, O'Brien MJ, Levin B, Smith RA, Lieberman DA, Burt RW, Levin TR, Bond JH, Brooks D, Byers T, Hyman N, Kirk L, Thorson A, Simmang C, Johnson D, Rex DK; US Multi-Society Task Force on Colorectal Cancer; American Cancer Society. Guidelines for colonoscopy surveillance after polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society. Gastroenterology. 2006 May;130(6):1872-85. doi: 10.1053/j.gastro.2006.03.012.

  PMID: 16697750 BACKGROUND

• Metz AJ, Moss A, McLeod D, Tran K, Godfrey C, Chandra A, Bourke MJ. A blinded comparison of the safety and efficacy of hot biopsy forceps electrocauterization and conventional snare polypectomy for diminutive colonic polypectomy in a porcine model. Gastrointest Endosc. 2013 Mar;77(3):484-90. doi: 10.1016/j.gie.2012.09.014. Epub 2012 Nov 27.

  PMID: 23199650 BACKGROUND

• Tsiamoulos ZP, Bourikas LA, Saunders BP. Endoscopic mucosal ablation: a new argon plasma coagulation/injection technique to assist complete resection of recurrent, fibrotic colon polyps (with video). Gastrointest Endosc. 2012 Feb;75(2):400-4. doi: 10.1016/j.gie.2011.09.003. Epub 2011 Dec 7.

  PMID: 22154411 BACKGROUND

• Anderloni A, Jovani M, Hassan C, Repici A. Advances, problems, and complications of polypectomy. Clin Exp Gastroenterol. 2014 Aug 30;7:285-96. doi: 10.2147/CEG.S43084. eCollection 2014.

  PMID: 25210470 BACKGROUND

• Varytimiadis L, Viazis N, Gkolfakis P, Tribonias G, Tziatzios G, Kyriakopoulos G, Argyrakos T, Pontas C, Papastergiou V, Arkadopoulos N, Smyrniotis V, Mantzaris GJ, Papanikolaou IS. Cold snare polypectomy vs. hot snare polypectomy vs. argon plasma coagulation for small (5-9mm) left-sided colorectal polyps: a prospective randomized trial. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e909-e915. doi: 10.1097/MEG.0000000000002300.

  PMID: 35048657 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

colonic polyps tissue samples

MeSH Terms

Conditions

Colonic Polyps

Interventions

Sigmoidoscopy; Colonoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Nikos Viazis, Director

  Evangelismos Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director gastroenterologist

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 24, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 10, 2020
• Last Updated: May 11, 2020

Record last verified: 2020-05

Locations

GR (1)