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

September 23, 2024 updated by: Zhijun Bao, Fudan University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Danian Ji, M.D.
  • Phone Number: +86-18019094606
  • Email: arctg4@163.com

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200040
        • Huadong Hospital Affiliated to Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
R0 resection
Time Frame: 2 weeks after the procedure
Rate of R0 resection in treating SSLs less than 10mm in size
2 weeks after the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
en bloc resection
Time Frame: immediately after the procedure
Rate of en bloc resection rate in treating SSLs less than 10mm in size
immediately after the procedure
Vertical margins
Time Frame: 2 weeks after the procedure
Rate of negative vertical margins in resected specimen
2 weeks after the procedure
Lateral margin
Time Frame: 2 weeks after the procedure
Rate of negative lateral margin in resected specimen
2 weeks after the procedure
Presence of muscularis mucosae
Time Frame: 2 weeks after the procedure
Rate of presence of muscularis mucosae in resected specimen
2 weeks after the procedure
Presence of submucosa
Time Frame: 2 weeks after the procedure
Rate of presence of submucosa in resected specimen
2 weeks after the procedure
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
immediately after the procedure
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).
2 weeks after the procedure
Delayed perforation
Time Frame: 2 weeks after the procedure
Rate of delayed perforation in treating SSLs less than 10mm in size
2 weeks after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Danian Ji, M.D., Huadong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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