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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2016 by Chonnam National University Hospital
Sponsor:
Information provided by (Responsible Party):
Chang Hwan Park, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT03000868
First received: December 20, 2016
Last updated: December 21, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention
Colonic Polyps
Procedure: Cold endoscopic mucosal resection
Procedure: Hot endoscopic mucosal resection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Small Colorectal Polyp Removal Using Cold Endoscopic Mucosal Resection With Hot Endoscopic Mucosal Resection: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures:
  • Complete removal of the colorectal polyp [ Time Frame: At the time of the procedure (endoscopic mucosal resection) ] [ Designated as safety issue: No ]
    The resected specimen will be reviewed microscopically to assess complete resection including the lateral and base margins


Secondary Outcome Measures:
  • Procedure time [ Time Frame: At the time of the procedure (endoscopic mucosal resection) ] [ Designated as safety issue: No ]
    The time needed for the hot EMR vs cold EMR (minutes) will be assessed.

  • Complication after endoscopic mucosal resection [ Time Frame: Within 1 month ] [ Designated as safety issue: Yes ]
    Procedure-related complications (bleeding, perforation, and post-coagulation syndrome) will be assessed.


Estimated Enrollment: 40
Study Start Date: December 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03000868

Contacts
Contact: Chang-hwan Park, M.D., Ph.D 82-62-220-6215 p1052ccy@hanmail.net
Contact: Eunae Cho, M.D> 82-62-220-6215 cea202@hanmail.net

Locations
Korea, Republic of
Chonnam National University Hospital Not yet recruiting
Gwangju, Korea, Republic of, 61469
Contact: Chang-hwan Park, M.D., Ph.D    82-62-220-6215    p1052ccy@hanmail.net   
Contact: Eunae Cho, M.D.    82-62-220-6215    cea202@hanmail.net   
Sponsors and Collaborators
Chonnam National University Hospital
Investigators
Study Director: Chang-hwan Park, M.D., Ph.D Chonnam National University Hospital
  More Information

Publications:
Responsible Party: Chang Hwan Park, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT03000868     History of Changes
Other Study ID Numbers: CNUH-2016-252 
Study First Received: December 20, 2016
Last Updated: December 21, 2016
Health Authority: Korea: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Individual participant data are not planned to be shared to other researchers.

Keywords provided by Chonnam National University Hospital:
Colonic Polyps
Endoscopic Mucosal Resection
Colonoscopy

Additional relevant MeSH terms:
Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps

ClinicalTrials.gov processed this record on January 14, 2017