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Trials / Withdrawn

WithdrawnNCT04253990

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

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Asan Medical Center · Academic / Other
Sex
All
Age
20 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPrecut EMRFor 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.
PROCEDUREConventional MEREMR 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.

Timeline

Start date
2016-05-01
Primary completion
2017-06-01
Completion
2017-06-01
First posted
2020-02-05
Last updated
2020-02-05

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT04253990. Inclusion in this directory is not an endorsement.