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

NCT ID: NCT06609031

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-10-01

Brief Summary

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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

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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.

Conditions

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Colorectal Sessile Serrated Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

endoscopic mucosal resection

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Cold snare polypectomy

Intervention Type PROCEDURE

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

Interventions

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endoscopic mucosal resection

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

Intervention Type PROCEDURE

Cold snare polypectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhijun Bao

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Danian Ji, M.D.

Role: STUDY_DIRECTOR

Huadong Hospital

Locations

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Huadong hospital affiliated to Fudan university

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Danian Ji, M.D.

Role: CONTACT

+86-18019094606

Zhiyu Dong, M.D.

Role: CONTACT

+86-18817870866

Facility Contacts

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Danian Ji, M.D.

Role: primary

+86-18019094606

Other Identifiers

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2024K225

Identifier Type: -

Identifier Source: org_study_id

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