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

NCT ID: NCT03000868

Last Updated: 2018-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-07-26

Brief Summary

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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

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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.

Conditions

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Colonic Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cold EMR group

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

Group Type EXPERIMENTAL

Cold endoscopic mucosal resection

Intervention Type PROCEDURE

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.

Hot EMR group

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

Group Type ACTIVE_COMPARATOR

Hot endoscopic mucosal resection

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chonnam National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Hwan Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang-hwan Park, M.D., Ph.D

Role: STUDY_DIRECTOR

Chonnam National University Hospital

Locations

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Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Countries

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South Korea

References

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Horiuchi A, Makino T, Ichise Y, Kajiyama M, Kato N, Tanaka N. Comparison of newly found polyps after removal of small colorectal polyps with cold or hot snare polypectomy. Acta Gastroenterol Belg. 2015 Dec;78(4):406-10.

Reference Type BACKGROUND
PMID: 26712051 (View on PubMed)

Lee SH, Shin SJ, Park DI, Kim SE, Hong SP, Hong SN, Yang DH, Lee BI, Kim YH, Kim HS, Yang SK, Kim HJ, Kim SH, Kim HJ; Multi-Society Task Force for Development of Guidelines for Colorectal Polyp Screening, Surveillance and Management. [Korean guidelines for colonoscopic polypectomy]. Korean J Gastroenterol. 2012 Feb;59(2):85-98. doi: 10.4166/kjg.2012.59.2.85. Korean.

Reference Type BACKGROUND
PMID: 22387834 (View on PubMed)

Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.

Reference Type BACKGROUND
PMID: 24125514 (View on PubMed)

Other Identifiers

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CNUH-2016-252

Identifier Type: -

Identifier Source: org_study_id

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