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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Sessile Serrated Lesion
• Intervention / Treatment: Procedure: endoscopic mucosal resection; Procedure: Cold snare polypectomy

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 Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danian Ji, M.D.; Phone Number: +86-18019094606; Email: arctg4@163.com
• Study Contact Backup: Name: Zhiyu Dong, M.D.; Phone Number: +86-18817870866; Email: 18817870866@163.com

Study Locations

• China
  • Shanghai, China, 200040
    • Huadong Hospital affiliated to Fudan University
    • Contact: Danian Ji, M.D.; Phone Number: +86-18019094606; Email: arctg4@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: endoscopic mucosal resection; The SSLs less than 10mm in size in this group will be treated by EMR
Active Comparator: 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.	Procedure: Cold snare polypectomy; The SSLs less than 10mm in size in this group will be treated by CSP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0 resection	Rate of R0 resection in treating SSLs less than 10mm in size	2 weeks after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
en bloc resection	Rate of en bloc resection rate in treating SSLs less than 10mm in size	immediately after the procedure
Vertical margins	Rate of negative vertical margins in resected specimen	2 weeks after the procedure
Lateral margin	Rate of negative lateral margin in resected specimen	2 weeks after the procedure
Presence of muscularis mucosae	Rate of presence of muscularis mucosae in resected specimen	2 weeks after the procedure
Presence of submucosa	Rate of presence of submucosa in resected specimen	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	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).	2 weeks after the procedure
Delayed perforation	Rate of delayed perforation in treating SSLs less than 10mm in size	2 weeks after the procedure

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Study Director: Danian Ji, M.D., Huadong Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: endoscopic mucosal resection; cold snare polypectomy; Sessile Serrated Lesion
• Other Study ID Numbers: 2024K225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD
• IPD Sharing Time Frame: 1 year after completion of this study
• IPD Sharing Access Criteria: All researchers can require the original data from principal investigator of this study (Email address: arctg4@163.com)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No