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

NCT ID: NCT04253990

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-06-30

Brief 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

Colonic Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Precut EMR

Intervention Type: PROCEDURE

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 EMR

For treating of 10~20mm colon polyp, patient will be randomly divided into two groups, a Precut-EMR group and a EMR group.

Conventional 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

Group Type: ACTIVE_COMPARATOR

Conventional MER

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dong-Hoon Yang

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong-hoon Yang

Role: STUDY_CHAIR

Asan Medical Center

Locations

Asan Medical Center

Seoul, Songpa-Gu, South Korea

Countries

South Korea

Other Identifiers

S2015-1496-0001

Identifier Type: -

Identifier Source: org_study_id