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

Colonic Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03000868
• Other study ID #: CNUH-2016-252
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: July 26, 2018

Study information

• Verified date: July 2018
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 26, 2018
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colonic Polyps
• Polyps

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View 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. — View 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. Korean. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedure time	The time needed for the hot EMR vs cold EMR (minutes) will be assessed.	At the time of the procedure (endoscopic mucosal resection)
Secondary	Complication after endoscopic mucosal resection	Procedure-related complications (bleeding, perforation, and post-coagulation syndrome) will be assessed.	Within 1 month