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

Primary Purpose

Colonic Polyps

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Precut EMR
Conventional MER
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Polyps focused on measuring Colonic polyps, Colonoscopy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Precut-EMR

Conventional EMR

Arm Description

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. 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

Outcomes

Primary Outcome Measures

Histologic complete resection rate

Secondary Outcome Measures

Procedure time
Complication such as perforation, bleeding

Full Information

First Posted
February 1, 2020
Last Updated
February 3, 2020
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04253990
Brief Title
Efficacy and Safety of Precut-EMR for Resecting of Colonic Polyp
Official Title
Comparison Between EMR and Precut-EMR for Colorectal Polyp; Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps
Keywords
Colonic polyps, Colonoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Precut-EMR
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional EMR
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Precut EMR
Intervention Description
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
Intervention Name(s)
Conventional MER
Intervention Description
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.
Primary Outcome Measure Information:
Title
Histologic complete resection rate
Time Frame
baseline ( enrollment of all planned patient)
Secondary Outcome Measure Information:
Title
Procedure time
Time Frame
procedure
Title
Complication such as perforation, bleeding
Time Frame
baseline ( enrollment of all planned patient)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-hoon Yang
Organizational Affiliation
Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-Gu
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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