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NCT Number: NCT06609031

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

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.

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

  • Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
  • 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).
  • Collecting variables which consist of primary and secodary outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic mucosal resection

Procedure

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

Cold snare polypectomy

Procedure

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

Primary outcomes

  1. R0 resection

    Time frame: 2 weeks after the procedure

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

Secondary outcomes

  1. en bloc resection

    Time frame: immediately after the procedure

    Rate of en bloc resection rate in treating SSLs less than 10mm in size

  2. Vertical margins

    Time frame: 2 weeks after the procedure

    Rate of negative vertical margins in resected specimen

  3. Lateral margin

    Time frame: 2 weeks after the procedure

    Rate of negative lateral margin in resected specimen

  4. Presence of muscularis mucosae

    Time frame: 2 weeks after the procedure

    Rate of presence of muscularis mucosae in resected specimen

  5. Presence of submucosa

    Time frame: 2 weeks after the procedure

    Rate of presence of submucosa in resected specimen

  6. Clinically Significant Immediate Post-polypectomy Bleeding(CSIPB)

    Time frame: 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

  7. Clinically Significant Delayed Post-polypectomy Bleeding(CSDPB)

    Time frame: 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).

  8. Delayed perforation

    Time frame: 2 weeks after the procedure

    Rate of delayed perforation in treating SSLs less than 10mm in size

Study contacts

Contact information is provided by the study sponsor or research team.

Danian Ji, M.D.

CONTACT

[email protected]

+86-18019094606

Zhiyu Dong, M.D.

CONTACT

[email protected]

+86-18817870866

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.