Cold or Hot Snare Endoscopic Mucosal Resection for 10-19mm Non-pedunculated Colorectal Polyps

April 30, 2026 updated by: Qingwei Jiang

A Prospective, Randomized, Non-inferiority Study to Compare Efficacy and Safety of Cold Snare Endoscopic Mucosal Resection and Hot Snare Endoscopic Mucosal Resection in Treatment for 10-19 mm Non-pedunculated Colorectal Polyps

This is a prospective, randomized, open-label, non-inferiority, multiple-center trial. Outpatients who are scheduled to undergo colonoscopy and found eligible polyps will be randomized to receive either cold snare endoscopic mucosal resection (CS-EMR) or hot snare endoscopic mucosal resection (HS-EMR). This study aims to compare the efficacy and safety of CS-EMR or HS-EMR for the resection of non-pedunculated colorectal polyps sized 10-19mm.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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 (Actual)

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.
216

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: Qingwei Jiang, MD
  • Phone Number: 8610-69151591
  • Email: flyerj@sina.com

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 102218
        • Beijing Tsinghua Changgung Hospital
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, Beijing Municipality, China, 100028
        • Emergency General Hospital
      • Beijing, Beijing Municipality, China, 100010
        • Beijing Dongcheng District First People's Hospital
      • Beijing, Beijing Municipality, China, 100191
        • Beijing Sixth Hospital
      • Beijing, Beijing Municipality, China, 100700
        • Seventh Medical Center, General Hospital of the Chinese People's Liberation Army
      • Beijing, Beijing Municipality, China, 102401
        • Beijing Fangshan District Liangxiang Hospital
      • Beijing, Beijing Municipality, China, 102600
        • Beijing Daxing District People's Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Provincial People's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
    • Shandong
      • Qingdao, Shandong, China, 266005
        • The Affiliated Hospital of Qingdao University
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • The First Hospital of Shanxi Medical University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Longquan Hospital, Sichuan University
      • Chengdu, Sichuan, China, 610083
        • PLA Western Theater General Hospital

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-80 years of age;
  • undergo colonoscopy in the Digestive Endoscopy Center of Peking Union Medical College Hospital, Beijing Tsinghua Changgung Hospital or Seventh Medical Center, General Hospital of the Chinese People's Liberation Army;
  • volunteer to participate in this study and sign informed consent;
  • at least one polyp sized 10-19 mm (Paris classification Is or IIa) by colonoscopy.

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) status class 3 or above;
  • poor bowel preparation (Boston bowel preparation scale < 6 points);
  • known or endoscopic features indicating the submucous infiltration or malignancy;
  • oral anti-coagulants, or antiplatelet agents, or known blood coagulation disorders, or bleeding tendency (platelets<50000 cells/mm3 or INR>1.5);
  • a history of colorectal resection;
  • emergency colonoscopy (hemodynamic instability and/or continued active gastrointestinal bleeding and/or requiring intensive care patients);
  • inflammatory bowel disease, familial polyposis, and colorectal cancer;
  • pregnancy or lactation;
  • severe cardiopulmonary dysfunction, liver cirrhosis, chronic kidney disease, other malignant tumors, or severe infectious diseases.

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: Cold snare endoscopic mucosal resection (CS-EMR)
Eligible colorectal polyps sized 10-19mm will be resected by CS-EMR
Procedure: Cold snare endoscopic mucosal resection
During CS-EMR, methylene blue-tinted epinephrine saline will be injected into the submucosal space around the lesion to lift the lesion. The polyp and 1-2mm of surrounding mucosa will then be closely snared and transected mechanically.
Experimental: Hot snare endoscopic mucosal resection (HS-EMR)
Eligible colorectal polyps sized 10-19mm will be resected by HS-EMR
Procedure: Hot snare endoscopic mucosal resection
During HS-EMR, methylene blue-tinted epinephrine saline will be injected into the submucosal space around the lesion to lift the lesion. The snare will be placed around the lesion, and then cautery will be applied using the electrosurgical generator.

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
Complete resection rate
Time Frame: Within 14 days
The resection is considered histologically complete if the lateral margins of the resected polyps are surrounded by normal tissue and the vertical margin is free of neoplasia tissue. If en-bloc resection is not achieved, 5 biopsies (4 biopsies obtained in a 4-quadrant fashion from the polypectomy site margins; 1 biopsy from the base) are applied to evaluate histological completeness of resection.
Within 14 days

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 rate
Time Frame: Within 1 day
The lesion was completely excised under endoscope and a single specimen was obtained.
Within 1 day
Intraprocedural bleeding
Time Frame: Within 1 day
Any immediate episode requiring any form of endoscopic hemostasis or oozing for more than 60s
Within 1 day
Intraprocedural perforation
Time Frame: Within 1 day
Endoscopic observation of perforation requiring sealing with clips
Within 1 day
Delayed bleeding
Time Frame: Within 14 days
Any episode requiring emergency department presentation, hospitalization, or reintervention within 14 days
Within 14 days
Delayed perforation
Time Frame: Within 14 days
Any perforation within 14 days
Within 14 days
Number of clips used
Time Frame: Within 1 day
The number of endoscopic clips used for each resected polyp
Within 1 day
Resection time
Time Frame: Within 1 day
The duration from the first occurrence of injection needle under endoscope visual field to complete removal of the resected polyp
Within 1 day
Total cost
Time Frame: Within 1 day
Total cost including both treatment cost and material cost for polyp resection
Within 1 day

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.
Qingwei Jiang

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.
  • Principal Investigator: Qingwei Jiang, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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 14, 2022

Primary Completion (Actual)

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.
April 15, 2026

Study Completion (Actual)

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.
April 15, 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 15, 2022

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 15, 2022

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 19, 2022

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.
May 1, 2026

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.
April 30, 2026

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.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • K2203

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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