Clinical trial NCT06609031: EMR Versus CSP in the Treatment of Sessile Serrated Lesions Less Than 10mm in Size
Official title: Endoscopic Mucosal Resection Versus Cold Snare Polypectomy in the Treatment of Sessile Serrated Lesions Less Than 10mm in Size: a Single-center, Open-label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Sessile Serrated Lesion
Keywords: Sessile Serrated Lesion
cold snare polypectomy
endoscopic mucosal resection
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 270
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, single-center, open-label, randomized controlled study to compare the effectiveness and safety of endoscopic mucosal resection (EMR) and cold snare polypectomy (CSP) in treating colorectal sessile serrated lesions (SSLs) less than 10mm in size.

Detailed description: 1. Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
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.

Eligibility criteria: Inclusion Criteria:

* Aged between 35 and 75 years
* 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:

* Unsuitable for removal by EMR or CSP
* 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

Primary outcomes:
measure: R0 resection
timeFrame: 2 weeks after the procedure
Secondary outcomes:
measure: en bloc resection
timeFrame: immediately after the procedure
measure: Vertical margins
timeFrame: 2 weeks after the procedure
measure: Lateral margin
timeFrame: 2 weeks after the procedure
measure: Presence of muscularis mucosae
timeFrame: 2 weeks after the procedure
measure: Presence of submucosa
timeFrame: 2 weeks after the procedure
measure: Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB）
timeFrame: immediately after the procedure
measure: Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB）
timeFrame: 2 weeks after the procedure
measure: Delayed perforation
timeFrame: 2 weeks after the procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huadong hospital affiliated to Fudan university
Study officials:
affiliation: Huadong Hospital
name: Danian Ji, M.D.
role: STUDY_DIRECTOR
References: