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

Primary Purpose

Colonic Polyps

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cold endoscopic mucosal resection
Hot endoscopic mucosal resection
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Polyps focused on measuring Colonic Polyps, Endoscopic Mucosal Resection, Colonoscopy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Chonnam National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cold EMR group

Hot EMR group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Complete removal of the colorectal polyp
The resected specimen will be reviewed microscopically to assess complete resection including the lateral and base margins

Secondary Outcome Measures

Procedure time
The time needed for the hot EMR vs cold EMR (minutes) will be assessed.
Complication after endoscopic mucosal resection
Procedure-related complications (bleeding, perforation, and post-coagulation syndrome) will be assessed.

Full Information

First Posted
December 20, 2016
Last Updated
July 26, 2018
Sponsor
Chonnam National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03000868
Brief Title
Comparison of Small Colorectal Polyp Removal Using Cold EMR With Hot EMR
Official Title
Comparison of Small Colorectal Polyp Removal Using Cold Endoscopic Mucosal Resection With Hot Endoscopic Mucosal Resection: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No participants were enrolled.
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
July 26, 2018 (Actual)
Study Completion Date
July 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps
Keywords
Colonic Polyps, Endoscopic Mucosal Resection, Colonoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cold EMR group
Arm Type
Experimental
Arm Description
Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare without electrocautery.
Arm Title
Hot EMR group
Arm Type
Active Comparator
Arm Description
Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare with the use of electrocautery.
Intervention Type
Procedure
Intervention Name(s)
Cold endoscopic mucosal resection
Intervention Description
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
Intervention Name(s)
Hot endoscopic mucosal resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete removal of the colorectal polyp
Description
The resected specimen will be reviewed microscopically to assess complete resection including the lateral and base margins
Time Frame
At the time of the procedure (endoscopic mucosal resection)
Secondary Outcome Measure Information:
Title
Procedure time
Description
The time needed for the hot EMR vs cold EMR (minutes) will be assessed.
Time Frame
At the time of the procedure (endoscopic mucosal resection)
Title
Complication after endoscopic mucosal resection
Description
Procedure-related complications (bleeding, perforation, and post-coagulation syndrome) will be assessed.
Time Frame
Within 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-hwan Park, M.D., Ph.D
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data are not planned to be shared to other researchers.
Citations:
PubMed Identifier
26712051
Citation
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.
Results Reference
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PubMed Identifier
22387834
Citation
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.
Results Reference
background
PubMed Identifier
24125514
Citation
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.
Results Reference
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Comparison of Small Colorectal Polyp Removal Using Cold EMR With Hot EMR

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