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

• Sponsor: Chonnam National University Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03000868
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.8
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyps	Procedure: Cold endoscopic mucosal resection; Procedure: Hot endoscopic mucosal resection	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Small Colorectal Polyp Removal Using Cold Endoscopic Mucosal Resection With Hot Endoscopic Mucosal Resection: a Pilot Study
• Actual Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Jul 26, 2018
• Actual Study Completion Date: Jul 26, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cold EMR group Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare without electrocautery.	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.
Active Comparator: Hot EMR group Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare with the use of electrocautery.	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.

Outcome Measures

Primary Outcome Measures

1. Complete removal of the colorectal polyp [At the time of the procedure (endoscopic mucosal resection)]

   The resected specimen will be reviewed microscopically to assess complete resection including the lateral and base margins

Secondary Outcome Measures

1. Procedure time [At the time of the procedure (endoscopic mucosal resection)]

   The time needed for the hot EMR vs cold EMR (minutes) will be assessed.

2. Complication after endoscopic mucosal resection [Within 1 month]

   Procedure-related complications (bleeding, perforation, and post-coagulation syndrome) will be assessed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chonnam National University Hospital	Gwangju		Korea, Republic of	61469

Sponsors and Collaborators

• Chonnam National University Hospital

Investigators

• Study Director: Chang-hwan Park, M.D., Ph.D, Chonnam National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Chang Hwan Park, Professor, Chonnam National University Hospital
• ClinicalTrials.gov Identifier: NCT03000868
• Other Study ID Numbers: CNUH-2016-252
• First Posted: Dec 22, 2016
• Last Update Posted: Jul 30, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Chang Hwan Park, Professor, Chonnam National University Hospital: Colonic Polyps; Endoscopic Mucosal Resection; Colonoscopy
• Additional relevant MeSH terms: Polyps; Colonic Polyps

Study Results

No Results Posted as of Jul 30, 2018