EMR Versus CSP in the Treatment of Sessile Serrated Lesions Less Than 10mm in Size

N/ANot Yet RecruitingNCT06609031

Fudan University270 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

270

Conditions

Colorectal Sessile Serrated Lesion

Interventions

endoscopic mucosal resectionPROCEDURE

The SSLs less than 10mm in size in this group will be treated by EMR

Cold snare polypectomyPROCEDURE

The SSLs less than 10mm in size in this group will be treated by CSP

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Huadong hospital affiliated to Fudan university

Shanghai, China

Outcomes

Primary Outcomes

R0 resection

Rate of R0 resection in treating SSLs less than 10mm in size

Time frame: 2 weeks after the procedure

Secondary Outcomes

en bloc resection

Rate of en bloc resection rate in treating SSLs less than 10mm in size

Time frame: immediately after the procedure

Vertical margins

Rate of negative vertical margins in resected specimen

Time frame: 2 weeks after the procedure

Lateral margin

Rate of negative lateral margin in resected specimen

Time frame: 2 weeks after the procedure

Presence of muscularis mucosae

Rate of presence of muscularis mucosae in resected specimen

Time frame: 2 weeks after the procedure

Presence of submucosa

Rate of presence of submucosa in resected specimen

Time frame: 2 weeks after the procedure

Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB）

CSIPB was defined as any bleeding not responding to water jet irrigation or STSC and therefore requiring either coagu lation forceps or mechanical clips to achieve hemostasis

Time frame: immediately after the procedure

Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB）

CSPEB was defined as any bleeding after completion of the procedure requiring emergency room presentation, hospital isation or re-intervention (endoscopy, angiography, surgery).

Central Contacts

Danian Ji, M.D.

CONTACT

+86-18019094606 arctg4@163.com

Zhiyu Dong, M.D.

CONTACT

+86-18817870866 18817870866@163.com

Data from ClinicalTrials.gov

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