Clinical trial NCT03000868: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Colonic Polyps
Keywords: Colonic Polyps
Endoscopic Mucosal Resection
Colonoscopy
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2016-12-22
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Complete removal of the colorectal polyp
timeFrame: At the time of the procedure (endoscopic mucosal resection)
Secondary outcomes:
measure: Procedure time
timeFrame: At the time of the procedure (endoscopic mucosal resection)
measure: Complication after endoscopic mucosal resection
timeFrame: Within 1 month
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Chang-hwan Park, M.D., Ph.D
role: STUDY_DIRECTOR
References:
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.
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.
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.