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Not yet recruiting NCT06609031

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

No phase Interventional Colorectal Sessile Serrated Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endoscopic mucosal resection, Cold snare polypectomy.
Who it may be relevant to
Registry conditions: Colorectal Sessile Serrated Lesion. Basic parameters: 35 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

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.

Interventions

  • Procedure endoscopic mucosal resection
    The SSLs less than 10mm in size in this group will be treated by EMR
  • Procedure Cold snare polypectomy
    The SSLs less than 10mm in size in this group will be treated by CSP

Primary outcome measures

  • R0 resection [Time frame: 2 weeks after the procedure]
Secondary outcome measures (8)
  • en bloc resection [Time frame: immediately after the procedure]
  • Vertical margins [Time frame: 2 weeks after the procedure]
  • Lateral margin [Time frame: 2 weeks after the procedure]
  • Presence of muscularis mucosae [Time frame: 2 weeks after the procedure]
  • Presence of submucosa [Time frame: 2 weeks after the procedure]
  • Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB） [Time frame: immediately after the procedure]
  • Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB） [Time frame: 2 weeks after the procedure]
  • Delayed perforation [Time frame: 2 weeks after the procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Huadong hospital affiliated to Fudan university — Shanghai

Identifiers

NCT: NCT06609031 · 2024K225

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗