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

Fudan University

Status: Not yet enrolling

Conditions: Colorectal Sessile Serrated Lesion

Treatments: Procedure: Cold snare polypectomy; Procedure: endoscopic mucosal resection

Study type: Interventional

Funder types: Other

Identifiers

NCT06609031

2024K225

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

EMR in treating SSLs less than 10mm in size

Experimental group

Description:

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

Treatment:

Procedure: endoscopic mucosal resection

CSP in treating SSLs less than 10mm in size

Active Comparator group

Description:

The CSP procedure included the following: (1) entrapment and resection of the polyp with a snare without electrocautery.

Treatment:

Procedure: Cold snare polypectomy