A Comparison of the Resection Rate of Cold Snare Polypectomy for Large (10-15 mm) and Small (5-9 mm) Colorectal Polyps

NCT03647176 | Completed

• 1 other identifier: PLA GH-CSP-1
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer remains the third most common cause of death from cancer worldwide. Colonoscopy allows removal of adenomatous polyps is the best colorectal cancer screening, according to the adenoma-carcinoma sequence. Recent studies have reported approximately 30% of interval cancer may be incomplete polyp resection. Complete polyp resection may be particularly important when implementing new methods for surveillance colonoscopies. Cold snare polypectomy (CSP) is considered to be a safer procedure for removing subcentimeter lesions than conventional hot snare polypectomy (HSP). CSP removal of polyps sized ≤5 mm have recommended by the European Society of Gastrointestinal Endoscopy guideline as the preferred technique. Previous report said that the complete resection rate of CSP for adenomatous polyps 4-9 mm in size was comparable to that of HSP, and in the foreseeable future CSP can be one of the standard techniques for 4-9 mm colorectal polyps. However, data on complete resection of colorectal polyps 1.0-1.5 mm in size is sparse. Investigators are interested in comparison of the resection rate of cold snare polypectomy for large (10-15 mm) and small (5-9 mm) colorectal polyps using CSP.

Conditions

Adenomatous Polyps

Keywords

Cold snare polypectomy; Colorectal polyps; CARE Study

Outcome Measures

Primary Outcomes (1)

• incomplete CSP resection rate of neoplastic polyps and subgroup analyses of possible factors that could contribute to an incomplete resection

  Incomplete resection was presence of neoplastic tissue from histopathologic examination of polyp margin biopsies. Subgroup included polyp size (5-7mm/8 -9mm/10 -15mm), location (right/left side was defined proximal/distal to the splenic flexure), location with respect to colonic folds (between/on the fold or not), flat morphology (measured by the tip of the 2.4-mm snare catheter), en bloc vs piecemeal resection, a snare exclusively designed as a cold snare versus traditional polypectomy snare, Neoplastic polyps( Adenoma, sessile serrated adenomas/polyps, high-grade dysplasia), and ease of polyp resection (easy or 30s; moderately difficult or 30-60s, difficult or 60s).

  six months

Secondary Outcomes (2)

• polypectomy procedure times

  six months

• the rates of procedure-related complications

  six months

Other Outcomes (2)

• adequate assessment of the polyp lateral or vertical margin

  1 year

• margins assess after resection

  1 year

Study Arms (2)

small polyps

ACTIVE COMPARATOR

Cold snare polypectomy ; Polyp size will be measured using the tip of the snare catheter (2.5mm).Small (5-9 mm) colorectal polyps will be removed with a polypectomy snare. Following the resection, jet stream of water will be used to wash mucosal defect thoroughly. After endoscopist's attestation that polyp removal was complete by carefully observe the resection margins with near focus mode, biopsies were performed from two marginal sites located symmetrically on the left and right of the mucosal defects to confirm residual polyp tissue.

Other: Cold snare polypectomy

large polyps

EXPERIMENTAL

Cold snare polypectomy; Polyp size will be measured using the tip of the snare catheter (2.5mm). Large (10-15 mm) colorectal polyps will be removed with a polypectomy snare. Following the resection, jet stream of water will be used to wash mucosal defect thoroughly. After endoscopist's attestation that polyp removal was complete by carefully observe the resection margins with near focus mode, 4 biopsies will be performed from all four quadrants of resection margins.

Other: Cold snare polypectomy

Interventions

Cold snare polypectomy OTHER

cold snare polypectomy (CSP), which does not include electrocautery to do a polypectomy with a snare

large polyps; small polyps

Eligibility Criteria

• Age: 40 Years - 85 Years
• Gender Eligibility Details: 40 Years to 85 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥40 and \<85
• Provide written informed consent
• Patients are found to have colorectal polyps between 5 and 15mm in size

You may not qualify if:

• History of inflammatory bowel disease
• Polyposis of the alimentary tract
• Antiplatelet or anticoagulant therapy 5 days before the procedure
• Pregnancy
• Haemodialysis
• An American Society of Anaesthesiologists class III or higher
• Depressed lesions and lesions highly suspected to be cancerous based on endoscopic appearance

Sponsors & Collaborators

• Yuqi He: lead

Study Sites (1)

Department of Gastroenterology, PLA Army General Hospital

Beijing, Dongcheng District, 100700, China

Location

Related Publications (3)

• 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 RESULT

• Matsuura N, Takeuchi Y, Yamashina T, Ito T, Aoi K, Nagai K, Kanesaka T, Matsui F, Fujii M, Akasaka T, Hanaoka N, Higashino K, Tomita Y, Ito Y, Ishihara R, Iishi H, Uedo N. Incomplete resection rate of cold snare polypectomy: a prospective single-arm observational study. Endoscopy. 2017 Mar;49(3):251-257. doi: 10.1055/s-0043-100215. Epub 2017 Feb 13.

  PMID: 28192823 RESULT

• Ma X, Feng X, Li Y, Du Y, Wang J, Wu Y, Jin H, Xie X, Wang X, Jin P, Yang L, Wang H, Leung J, Sheng J, He Y. A Comparison of Incomplete Resection Rate of Large and Small Colorectal Polyps by Cold Snare Polypectomy. Clin Gastroenterol Hepatol. 2022 May;20(5):1163-1170. doi: 10.1016/j.cgh.2021.11.010. Epub 2021 Nov 17.

  PMID: 34798334 DERIVED

MeSH Terms

Conditions

Adenomatous Polyps

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• tianyang zhang

  Medical department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 27, 2018
• Study Start: September 3, 2018
• Primary Completion: January 15, 2020
• Study Completion: February 1, 2020
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)