EMR Versus CSP in the Treatment of Sessile Serrated Lesions Less Than 10mm in Size
NCT ID: NCT06609031
Last Updated: 2024-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
270 participants
INTERVENTIONAL
2024-10-01
2026-10-01
Brief Summary
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Detailed Description
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2. Randomize patients with suspicious sessile serrated lesions (SSLs) less than 10mm in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Endoscopic mucosal resection (EMR) and (2) Group 2: Cold snare polypectomy (CSP).
3. Collecting variables which consist of primary and secodary outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EMR in treating SSLs less than 10mm in size
The EMR procedure included the following: (1) needle injection of normal saline into the submucosa; (2) entrapment of the mucosal protrusion with a snare; and (3) resection using electrocautery
endoscopic mucosal resection
The SSLs less than 10mm in size in this group will be treated by EMR
CSP in treating SSLs less than 10mm in size
The CSP procedure included the following: (1) entrapment and resection of the polyp with a snare without electrocautery.
Cold snare polypectomy
The SSLs less than 10mm in size in this group will be treated by CSP
Interventions
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endoscopic mucosal resection
The SSLs less than 10mm in size in this group will be treated by EMR
Cold snare polypectomy
The SSLs less than 10mm in size in this group will be treated by CSP
Eligibility Criteria
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Inclusion Criteria
* Suspected sessile serrated lesions less than 10mm in size in screening, surveillance or therapeutic colonoscopy
* 0-Is or 0-IIa according to Paris classification
* Type 1 according to NICE and JNET classification
* Type II according to pit pattern
* Patients must sign an informed consent form prior to registration in study
Exclusion Criteria
* Suspected dysplasia or malignancy
* Recurrent sessile serrated lesions after endoscopic resection
* Familial adenomatous polyposis, Lynch syndrome or serrated polyposis syndrome
* History of inflammatory bowel disease
* Patients taking anticoagulant and antiplatelet agents before the examination
* Severe illness or other high-risk conditions that prevent the patient from cooperating with or tolerating endoscopic therapy
* Refusal to sign the informed consent form or any other factors that are not suitable for enrollment or affect the ability to participate in the study
35 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhijun Bao
Director
Principal Investigators
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Danian Ji, M.D.
Role: STUDY_DIRECTOR
Huadong Hospital
Locations
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Huadong hospital affiliated to Fudan university
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024K225
Identifier Type: -
Identifier Source: org_study_id
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