NCT03000868

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2018

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

1.6 years

First QC Date

December 20, 2016

Last Update Submit

July 26, 2018

Conditions

Colonic Polyps

Keywords

Colonic PolypsEndoscopic Mucosal ResectionColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Complete removal of the colorectal polyp

    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 Outcomes (2)

  • Procedure time

    At the time of the procedure (endoscopic mucosal resection)

  • Complication after endoscopic mucosal resection

    Within 1 month

Study Arms (2)

Cold EMR group

EXPERIMENTAL

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

Procedure: Cold endoscopic mucosal resection

Hot EMR group

ACTIVE COMPARATOR

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

Procedure: Hot endoscopic mucosal resection

Interventions

Cold endoscopic mucosal resectionPROCEDURE

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.

Cold EMR group
Hot endoscopic mucosal resectionPROCEDURE

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.

Hot EMR group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with colorectal polyps that are \<1cm in diameter who need endoscopic mucosal resection.
  • Patients who gave informed consents to this study.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 26712051BACKGROUND

  • 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.

    PMID: 22387834BACKGROUND

  • 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.

    PMID: 24125514BACKGROUND

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Chang-hwan Park, M.D., Ph.D

    Chonnam National University Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 22, 2016

Study Start

December 1, 2016

Primary Completion

July 26, 2018

Study Completion

July 26, 2018

Last Updated

July 30, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

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

Locations

KR(1)