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

Not Applicable

Not yet recruiting

• Conditions: Colorectal Sessile Serrated Lesion
• Interventions: Procedure: endoscopic mucosal resection; Procedure: Cold snare polypectomy

• Registration Number: NCT06609031
• Lead Sponsor: Fudan University

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Study Start: 2024-10-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 270

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 participant's ability to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMR in treating SSLs less than 10mm in size	endoscopic mucosal resection	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
CSP in treating SSLs less than 10mm in size	Cold snare polypectomy	The CSP procedure included the following: (1) entrapment and resection of the polyp with a snare without electrocautery.

Primary Outcome Measures

Name	Time	Method
R0 resection	2 weeks after the procedure	Rate of R0 resection in treating SSLs less than 10mm in size

Secondary Outcome Measures

Name	Time	Method
en bloc resection	immediately after the procedure	Rate of en bloc resection rate in treating SSLs less than 10mm in size
Vertical margins	2 weeks after the procedure	Rate of negative vertical margins in resected specimen
Lateral margin	2 weeks after the procedure	Rate of negative lateral margin in resected specimen
Presence of muscularis mucosae	2 weeks after the procedure	Rate of presence of muscularis mucosae in resected specimen
Presence of submucosa	2 weeks after the procedure	Rate of presence of submucosa in resected specimen
Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB）	immediately after the procedure	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
Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB）	2 weeks after the procedure	CSPEB was defined as any bleeding after completion of the procedure requiring emergency room presentation, hospital isation or re-intervention (endoscopy, angiography, surgery).
Delayed perforation	2 weeks after the procedure	Rate of delayed perforation in treating SSLs less than 10mm in size

Trial Locations

Locations (1)

Huadong hospital affiliated to Fudan university; 🇨🇳 Shanghai, China