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

February 3, 2020 updated by: Dong-Hoon Yang, Asan Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Songpa-Gu
      • Seoul, Songpa-Gu, Korea, Republic of, 05505
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

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.

Active Comparator: 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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Histologic complete resection rate
Time Frame: baseline ( enrollment of all planned patient)
baseline ( enrollment of all planned patient)

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedure time
Time Frame: procedure
procedure
Complication such as perforation, bleeding
Time Frame: baseline ( enrollment of all planned patient)
baseline ( enrollment of all planned patient)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Dong-hoon Yang, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

February 1, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • S2015-1496-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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