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Clinical Trials/NCT03000868
NCT03000868WithdrawnNot Applicable

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

Chonnam National University Hospital2 sites in 1 countryStarted: December 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
2
Primary Endpoint
Complete removal of the colorectal polyp

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Cold EMR group

Experimental

Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare without electrocautery.

Intervention: Cold endoscopic mucosal resection (Procedure)

Hot EMR group

Active Comparator

Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare with the use of electrocautery.

Intervention: Hot endoscopic mucosal resection (Procedure)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Procedure time(At the time of the procedure (endoscopic mucosal resection))
  • Complication after endoscopic mucosal resection(Within 1 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chang Hwan Park

Professor

Chonnam National University Hospital

Study Sites (2)

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