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A Comparison of the Resection Rate of Cold Snare Polypectomy for Large (10-15 mm) and Small (4-9 mm) Colorectal Polyps (CSP)

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ClinicalTrials.gov Identifier: NCT03647176
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Yuqi He, General Hospital of Beijing PLA Military Region

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 (4-9 mm) colorectal polyps using CSP.

Condition or disease Intervention/treatment Phase
Adenomatous Polyps Other: Cold snare polypectomy Not Applicable

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 (GIF-HQ290I) and polypectomy snares.

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 (4-9mm) 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: PLA Army General Hospital of Beijing
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Arm Intervention/treatment
Active Comparator: small polyps
Cold snare polypectomy ; Polyp size will be measured using the tip of the snare catheter (2.5mm).Small (4-9 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
cold snare polypectomy (CSP), which does not include electrocautery to do a polypectomy with a snare

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




Primary Outcome Measures :
  1. Percent of Incompletely Resected Adenomatous Polyps [ Time Frame: six months ]
    Proportion of incomplete adenoma resection (5 to 15mm), defined by adenomatous tissue pathological detection in marginal biopsies after endoscopist observation


Secondary Outcome Measures :
  1. adequate assessment of the polyp lateral margin [ Time Frame: six months ]
    Pathological assessment

  2. tissue retrieval per polyp [ Time Frame: six months ]
    tissue retrieval rate

  3. polypectomy procedure times [ Time Frame: six months ]
    Time required for resection was defined as the time between the insertion of the snare into working channel to the end of polyp resection

  4. the rates of procedure-related complications [ Time Frame: six months ]
    Delayed bleeding was defined as haemorrhage after colonoscopy requiring endoscopic haemostasis



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   40 Years to 85 Years
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647176


Contacts
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Contact: yuqi he +801066721299 endohe@163.com

Locations
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China, Dongcheng District
Department of Gastroenterology, PLA Army General Hospital Recruiting
Beijing, Dongcheng District, China, 100700
Contact: yuqi he         
Sponsors and Collaborators
Yuqi He
Investigators
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Principal Investigator: tianyang zhang Medical department

Publications of Results:
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Responsible Party: Yuqi He, Principal Investigator, Clinical Professor, General Hospital of Beijing PLA Military Region
ClinicalTrials.gov Identifier: NCT03647176     History of Changes
Other Study ID Numbers: PLA GH-CSP-1
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual participant data can be seen after article been published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yuqi He, General Hospital of Beijing PLA Military Region:
Cold snare polypectomy
Colorectal polyps
CARE Study

Additional relevant MeSH terms:
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Adenomatous Polyps
Polyps
Pathological Conditions, Anatomical
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms