search
Back to results

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

Primary Purpose

Adenomatous Polyps

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cold snare polypectomy
Sponsored by
Yuqi He
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adenomatous Polyps focused on measuring Cold snare polypectomy, Colorectal polyps, CARE Study

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Gastroenterology, PLA Army General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

small polyps

large polyps

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

polypectomy procedure times
Time required for resection was defined as the time between the insertion of the snare into working channel to the end of polyp resection
the rates of procedure-related complications
Delayed bleeding was defined as haemorrhage after colonoscopy requiring endoscopic haemostasis;submucosal disruption; perforation

Full Information

First Posted
August 22, 2018
Last Updated
February 27, 2020
Sponsor
Yuqi He
search

1. Study Identification

Unique Protocol Identification Number
NCT03647176
Brief Title
A Comparison of the Resection Rate of Cold Snare Polypectomy for Large (10-15 mm) and Small (5-9 mm) Colorectal Polyps
Acronym
CSP
Official Title
PLA Army General Hospital of Beijing
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yuqi He

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Participantswho meet inclusion criteria will be asked to participate, investigators will include all patients with resectable polyps, but only adenomatous polyps will be included for analysis. See also inclusion and exclusion criteria. Colonoscopy, after bowel preparation with polyethylene glycol solution was performed using standard colonoscopes (CF-HQ290I, CF-Q260AI) and polypectomy snares(13mm Captivator and 10mm Captivator II). All procedures were performed by experienced endoscopists (each with over 1000 colonoscopies performed) including CSP. All polyps between 5 and 15mm will be removed with a polypectomy snare. Polyp size will be measured using the tip of the snare catheter (2.5mm). Difficulty of resection will be grade by polyp resection time. 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, for large lesions (10-15mm) 4 biopsies will be performed from all four quadrants of resection margins, for small lesions (5-9mm) biopsies were performed from two marginal sites located symmetrically on the left and right of the mucosal defects to confirm residual polyp tissue. If polyp resection is complicated by bleeding (not self-sustained), no biopsies will be taken and any additional polyps that will be found during the remaining examination will be excluded from analysis. Severe bleeding that will complicate resection margins examination will be excluded from analysis, Endoscopic haemostasis will be performed when active haemorrhage continued for ≥30s. A single research subject may have many eligible polyps. To avoid taking many biopsies, the investigators will not include more than 5 eligible polyps (the first 5 that are detected) per patient in the study. Laboratory Analysis: The polyps will be evaluated by experienced pathologists according to Vienna classification. Resection margins for each polyp will be recorded as: R0= adenomatous tissue free, R1=adenomatous tissue detection. Investigators will only include adenomatous polyps in the analysis. for financial requests of the resection margin biopsies. The pathological diagnosis of the biopsies will become part of the medical record. If biopsies contain adenomatous tissue the participants will be ask to return for a follow-up colonoscopy within six month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomatous Polyps
Keywords
Cold snare polypectomy, Colorectal polyps, CARE Study

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
small polyps
Arm Type
Active Comparator
Arm Description
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.
Arm Title
large polyps
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cold snare polypectomy
Intervention Description
cold snare polypectomy (CSP), which does not include electrocautery to do a polypectomy with a snare
Primary Outcome Measure Information:
Title
incomplete CSP resection rate of neoplastic polyps and subgroup analyses of possible factors that could contribute to an incomplete resection
Description
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).
Time Frame
six months
Secondary Outcome Measure Information:
Title
polypectomy procedure times
Description
Time required for resection was defined as the time between the insertion of the snare into working channel to the end of polyp resection
Time Frame
six months
Title
the rates of procedure-related complications
Description
Delayed bleeding was defined as haemorrhage after colonoscopy requiring endoscopic haemostasis;submucosal disruption; perforation
Time Frame
six months
Other Pre-specified Outcome Measures:
Title
adequate assessment of the polyp lateral or vertical margin
Description
Pathological assessment
Time Frame
1 year
Title
margins assess after resection
Description
narrow band imaging to delineate polyp margins
Time Frame
1 year

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
40 Years to 85 Years
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient ≥40 and <85 Provide written informed consent Patients are found to have colorectal polyps between 5 and 15mm in size Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tianyang zhang
Organizational Affiliation
Medical department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, PLA Army General Hospital
City
Beijing
State/Province
Dongcheng District
ZIP/Postal Code
100700
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
individual participant data can be seen after article been published
Citations:
PubMed Identifier
28970290
Citation
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.
Results Reference
result
PubMed Identifier
28192823
Citation
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.
Results Reference
result
PubMed Identifier
34798334
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs