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

NCT06609031 | Not Yet Recruiting

• 1 other identifier: 2024K225
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Sessile Serrated Lesion

Keywords

Sessile Serrated Lesion; cold snare polypectomy; endoscopic mucosal resection

Outcome Measures

Primary Outcomes (1)

• R0 resection

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

  2 weeks after the procedure

Secondary Outcomes (8)

• en bloc resection

  immediately after the procedure

• Vertical margins

  2 weeks after the procedure

• Lateral margin

  2 weeks after the procedure

• Presence of muscularis mucosae

  2 weeks after the procedure

• Presence of submucosa

  2 weeks after the procedure

Study Arms (2)

EMR in treating SSLs less than 10mm in size

EXPERIMENTAL

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

CSP in treating SSLs less than 10mm in size

ACTIVE COMPARATOR

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

Procedure: Cold snare polypectomy

Interventions

endoscopic mucosal resection PROCEDURE

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

EMR in treating SSLs less than 10mm in size

Cold snare polypectomy PROCEDURE

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

CSP in treating SSLs less than 10mm in size

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 35 and 75 years
• Suspected sessile serrated lesions less than 10mm in size in screening, surveillance or therapeutic colonoscopy
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huadong hospital affiliated to Fudan university

Shanghai, 200040, China

Location

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Danian Ji, M.D.

  Huadong Hospital

  STUDY DIRECTOR

Central Study Contacts

Danian Ji, M.D.

CONTACT

+86-18019094606; arctg4@163.com

Zhiyu Dong, M.D.

CONTACT

+86-18817870866; 18817870866@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year after completion of this study
• Access Criteria: All researchers can require the original data from principal investigator of this study (Email address: arctg4@163.com)

Locations

CN (1)