Efficacy and Safety of Precut-EMR for Resecting of Colonic Polyp

Colonic Polyps Clinical Trial

Official title:

Comparison Between EMR and Precut-EMR for Colorectal Polyp; Randomized Prospective Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04253990
• Other study ID #: S2015-1496-0001
• Status: Withdrawn
• Phase: N/A
• Start date: May 2016
• Est. completion date: June 2017

Study information

• Verified date: February 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was attempted to determine the efficacy and complication of precut EMR comparing with convetional EMR for resecting of 10 ~ 20 mm colon polyp through prospective, randomized controlled trial.

Description:

In general, a potential risk of advanced colorectal neoplasia is proportional with size. However, recent study report that occurence rate of advanced neoplasia in small polyp is 9 ~ 10 %. And, incidence of interval cancer after screening colonoscopy was reported as 10 ~ 27%. So We can suspect that complete resection of small polyp is important. Previous study recommended that endoscopic submucosal dissection (ESD) is a safe and effective procedure for treating colon polyp larger than 20 mm because of high complete resection rate and low recurrence rate. In contrast, endoscopic mucosal resection (EMR) is more recommended for resecting colon polyp smaller than 20 mm because of technical ease and low rate of complication.

However, Complete resection rate of conventional EMR is 60 ~ 70%. In case of incomplete resection, local recurrence rate is higher than complete resection. And In case of adenocarcinoma, specimen of piecemeal resection cannot be evaluated a depth of invasion and resection margin, and physician cannot decide a therapeutic plan.

In precut-EMR, mucosal resection is performed after pre-incision around a polyp. When precut EMR of polyp > 20 mm was performed in previous study, complete resection rate and en-bloc resection rate were higher and local recurrence rate was lower than conventional EMR. But, there is no study of comparsion precut EMR and conventional EMR for resecting colon polyp < 20 mm. This study was attempted to determine the efficacy and complication of precut EMR comparing with convetional EMR through prospective, randomized controlled trial.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• All patients older than 20 years old who had 10~20 mm colon polyp and agreed to participate a research

Exclusion Criteria:

• Medication history of antiplatelet agent within a week of procedure.

• Medical history of coagulopathy

• More than American Society of Anesthesiology class III

• Medical history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel disease, severe inflammatory disease.

• pedunculated polyp and polyp with malignant potential.

Related Conditions & MeSH terms

• Colonic Polyps
• Polyps

Intervention

Procedure:
• Precut EMR
For treating of 10~20mm colon polyp, patient will be randomly divided into two groups, a Precut-EMR group and a EMR group. In Precut-EMR, endoscopist submucosally inject with saline around a polyp. Subsequently, circumferential incision/precutting was made with the tip of the snare around 2 mm outside the tumor. After that, the snare was positioned in the cut groove and tightend, and the tumor was resected using electrical current.
• Conventional MER
EMR had been widely used technique. Endoscopist submucosally inject with saline around a polyp. After that, snare is positioned around a polyp, and polyp was resected using electrical current.

Locations

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

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	Histologic complete resection rate		baseline ( enrollment of all planned patient)
Secondary	Procedure time		procedure
Secondary	Complication such as perforation, bleeding		baseline ( enrollment of all planned patient)