Comparison of Small Colorectal Polyp Removal Using Cold EMR With Hot EMR

July 26, 2018 updated by: Chang Hwan Park, Chonnam National University Hospital

Comparison of Small Colorectal Polyp Removal Using Cold Endoscopic Mucosal Resection With Hot Endoscopic Mucosal Resection: a Pilot Study

This study evaluates the efficacy of small colorectal polyp removal using cold endoscopic mucosal resection with hot endoscopic mucosal resection. Half of the participants will receive cold endoscopic mucosal resection, while the other half will receive hot endoscopic mucosal resection.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Colorectal polyps are considered as precancerous lesions and endoscopical resection is currently the treatment of choice when it is possible.

Colorectal polyps are classified into diminutive polyps (<5mm in diameter), small polyps (6-9mm in diameter), and large polyps (>1cm in diameter). There are several endoscopical treatment methods: cold biopsy forceps polypectomy, cold snare polypectomy, hot biopsy forceps polypectomy, hot snare polypectomy, and endoscopic mucosal resection. Cold polypectomy means mechanical removal of the polyp with snare or biopsy forceps without the use of electrocautery, and hot polypectomy means removal of the polyp with the use of electocautery.

Study Type

Interventional

Phase

  • 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 Locations

  • Korea, Republic of
      • Gwangju, Korea, Republic of, 61469
        • Chonnam National University 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

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with colorectal polyps that are <1cm in diameter who need endoscopic mucosal resection.

    • Patients who gave informed consents to this study.

Exclusion Criteria:

  • Patients under the age of 19
  • Patients who are receiving antiplatelet or anticoagulant therapies
  • Patients with hypercoagulability (i.e., liver cirrhosis, hemophilia, end-stage renal disease, or chronic kidney disease)

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
Intervention / Treatment
Experimental: Cold EMR group
Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare without electrocautery.
Procedure: Cold endoscopic mucosal resection
Cold endoscopic mucosal resection (EMR) means removing small colorectal polyps (<1cm) with snare without the use of electocautery after injection of normal saline into the submucosa.
Active Comparator: Hot EMR group
Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare with the use of electrocautery.
Procedure: Hot endoscopic mucosal resection
Hot endoscopic mucosal resection (EMR) means removing small colorectalpolyps (<1cm) with snare without the use of electocautery after injection of normal saline into the submucosa.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete removal of the colorectal polyp
Time Frame: At the time of the procedure (endoscopic mucosal resection)
The resected specimen will be reviewed microscopically to assess complete resection including the lateral and base margins
At the time of the procedure (endoscopic mucosal resection)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure time
Time Frame: At the time of the procedure (endoscopic mucosal resection)
The time needed for the hot EMR vs cold EMR (minutes) will be assessed.
At the time of the procedure (endoscopic mucosal resection)
Complication after endoscopic mucosal resection
Time Frame: Within 1 month
Procedure-related complications (bleeding, perforation, and post-coagulation syndrome) will be assessed.
Within 1 month

Collaborators and Investigators

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

Sponsor

Chonnam National University Hospital

Investigators

  • Study Director: Chang-hwan Park, M.D., Ph.D, Chonnam National University 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)

December 1, 2016

Primary Completion (Actual)

July 26, 2018

Study Completion (Actual)

July 26, 2018

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 21, 2016

First Posted (Estimate)

December 22, 2016

Study Record Updates

Last Update Posted (Actual)

July 30, 2018

Last Update Submitted That Met QC Criteria

July 26, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNUH-2016-252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data are not planned to be shared to other researchers.

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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