Polypectomy With Hot vs Cold Snare in Small Colonic Lesions

NCT03783156 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy is the technique of choice for the diagnosis and prevention of colorectal cancer (CRC). The identification and extirpation of adenomas decreases the incidence of CRC by up to 76%. More than 70% of the excised lesions are less than 10 mm. There is controversy about the technique to be used (resection with cold vs hot snare) in lesions of 5-9mm. Both use a polypectomy snare. The cold snare cuts by friction, while the hot snare uses electrical current. We propose a multicenter randomized clinical trial comparing both endoscopic techniques. At least 394 injuries per group will be included, randomizing patients to whom a diagnostic colonoscopy is requested for symptoms, screening or revision protocols. Randomization will be performed stratified by center. The primary objective is the proportion of incomplete polypectomies, which will be analyzed centrally from random biopsies of the edges of the lesion. As secondary objectives, we will compare the proportion of immediate and delayed hemorrhagic complications, the evolution of postprocedural abdominal pain and the factors associated with incomplete excision in each group and the factors associated with a failed cold polypectomy. The analysis of the primary objective will be carried out by means of the z test of homogeneity without using the correction of Yates, estimating the confidence interval of the difference between both groups. The analysis will be carried out by intention to treat and per protocol.

Conditions

Polyp of Colon; Gastrointestinal Bleeding; Colonic Adenoma

Keywords

polypectomy snare; polypectomy complications

Outcome Measures

Primary Outcomes (1)

• Number of participants with presence of adenomatous tissue al the base of polypectomy

  Number of patients with polypoid tissue at the base of polypectomy

  3 months

Secondary Outcomes (1)

• Number of participants with Postpolypectomy Complications

  21-28 days

Study Arms (2)

hot snare

OTHER

polypectomy with hot snare

Procedure: hot snare

cold snare

OTHER

polypectomy with cold snare

Procedure: cold snare

Interventions

hot snare PROCEDURE

polypectomy with hot snare

hot snare

cold snare PROCEDURE

polypectomy with cold snare

cold snare

Eligibility Criteria

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

You may qualify if:

• Patients older than 18 years scheduled to undergo a colonoscopy.

You may not qualify if:

• Absence of lesions of 5-9 mm.
• Contraindication for polypectomy (anticoagulant treatment, treatment with clopidogrel, coagulopathy or severe thrombocytopenia)
• Loss of polypectomy specimen
• Refusal to participate

Sponsors & Collaborators

• Hospital del Rio Hortega: lead

Study Sites (1)

Hospital Rio Hortega

Valladolid, 47012, Spain

Location

Related Publications (8)

• Kawamura T, Takeuchi Y, Asai S, Yokota I, Akamine E, Kato M, Akamatsu T, Tada K, Komeda Y, Iwatate M, Kawakami K, Nishikawa M, Watanabe D, Yamauchi A, Fukata N, Shimatani M, Ooi M, Fujita K, Sano Y, Kashida H, Hirose S, Iwagami H, Uedo N, Teramukai S, Tanaka K. A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study). Gut. 2018 Nov;67(11):1950-1957. doi: 10.1136/gutjnl-2017-314215. Epub 2017 Sep 28.

  PMID: 28970290 BACKGROUND

• Noda H, Ogasawara N, Sugiyama T, Yoshimine T, Tamura Y, Izawa S, Kondo Y, Ebi M, Funaki Y, Sasaki M, Kasugai K. The Influence of Snare Size on the Utility and Safety of Cold Snare Polypectomy for the Removal of Colonic Polyps in Japanese Patients. J Clin Med Res. 2016 Sep;8(9):662-6. doi: 10.14740/jocmr2646w. Epub 2016 Jul 30.

  PMID: 27540440 BACKGROUND

• Din S, Ball AJ, Riley SA, Kitsanta P, Johal S. A randomized comparison of cold snare polypectomy versus a suction pseudopolyp technique. Endoscopy. 2015 Nov;47(11):1005-10. doi: 10.1055/s-0034-1392533. Epub 2015 Jul 10.

  PMID: 26165735 BACKGROUND

• Lee CK, Shim JJ, Jang JY. Cold snare polypectomy vs. Cold forceps polypectomy using double-biopsy technique for removal of diminutive colorectal polyps: a prospective randomized study. Am J Gastroenterol. 2013 Oct;108(10):1593-600. doi: 10.1038/ajg.2013.302. Epub 2013 Sep 17.

  PMID: 24042189 BACKGROUND

• Pohl H, Srivastava A, Bensen SP, Anderson P, Rothstein RI, Gordon SR, Levy LC, Toor A, Mackenzie TA, Rosch T, Robertson DJ. Incomplete polyp resection during colonoscopy-results of the complete adenoma resection (CARE) study. Gastroenterology. 2013 Jan;144(1):74-80.e1. doi: 10.1053/j.gastro.2012.09.043. Epub 2012 Sep 25.

  PMID: 23022496 BACKGROUND

• Pattullo V, Bourke MJ, Tran KL, McLeod D, Williams SJ, Bailey AA, Alexander S, Mishra A, Co J. The suction pseudopolyp technique: a novel method for the removal of small flat nonpolypoid lesions of the colon and rectum. Endoscopy. 2009 Dec;41(12):1032-7. doi: 10.1055/s-0029-1215294. Epub 2009 Nov 6.

  PMID: 19899034 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

• Aslan F, Camci M, Alper E, Akpinar Z, Arabul M, Celik M, Unsal B. Cold snare polypectomy versus hot snare polypectomy in endoscopic treatment of small polyps. Turk J Gastroenterol. 2014 Jun;25(3):279-83. doi: 10.5152/tjg.2014.5085.

  PMID: 25141316 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps; Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes

Study Officials

• Marina de Benito, MD

  Hospital Río Hortega

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 20, 2018
• Study Start: February 18, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)