Cold Snare Polypectomy Versus. Endoscopic Mucosal Resection

Colonic Polyp Clinical Trial

Official title:

Comparison of Efficacy Between Cold Snare Polypectomy and Endoscopic Mucosal Resection in Treatment of Small Polyp

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02476747
• Other study ID #: 2015-0565
• Status: Recruiting
• Phase: N/A
• First received: June 17, 2015
• Last updated: June 23, 2015
• Start date: June 2015
• Est. completion date: October 2015

Study information

• Verified date: June 2015
• Source: Asan Medical Center
• Contact: Jeong-Sik Byeon, Doctor
• Phone: 82-2-3010-3905
• Email: jsbyeon[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators will investigate the efficacy of EMR compared to CSP in treatment of small colon polp (6~10mm).

One aim of this study was to investigate the necessity of EMR on resection of small colon polyp.

Description:

With sized polyp from 6mm to less than 10mm, it has been classified by the previous studies as a "small polyp".

Their potential for advanced neoplasia is usually size-dependent, but some recent studies found that, even in diminutive and small polyps, the rate of advanced neoplasia is relatively high about 9%-10%.

The investigators will prospectively investigate postprocedural outcomes, such as retrieval rate, procedural time, overall complication rate (Intraprocedural bleeding, postprocedural bleeding, and perforation) in colonoscopic polypectomy of small polyp between CSP and EMR.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 103
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• All those over the age of 20 years who agree informed consent and who have at least one polyp of eligible size (6-10 mm)

Exclusion Criteria:

• (1) patients taking anticoagulant therapy during the past 1 week of the procedure, (2) known coagulopathy, (3) history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel diseases or significant infectious disease, (4) American Society of Anesthesiology class III or more, and (5) pedunculated polyps and polyps with malignant feature.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Intervention

Other:
• EMR
performing EMR for patients with small polyp
• CSP
performing CSP for patients with small polyp

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete resection rate (CRR)		Up to 2 months	No
Secondary	incidence of complications (Intraprocedural bleeding, postprocedural bleeding, and perforation)		Up to 2 months	Yes
Secondary	necessity of hemostasis (due to Intraprocedural bleeding or postprocedural bleeding)		Up to 2 months	No
Secondary	Polyp retrieval rate		Up to 2 months	No
Secondary	hospitalization period		Up to 2 months	No