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

NCT04253990 | Withdrawn

• 1 other identifier: S2015-1496-0001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyps

Keywords

Colonic polyps; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Histologic complete resection rate

  baseline ( enrollment of all planned patient)

Secondary Outcomes (2)

• Procedure time

  procedure

• Complication such as perforation, bleeding

  baseline ( enrollment of all planned patient)

Study Arms (2)

Precut-EMR

EXPERIMENTAL

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.

Procedure: Precut EMR

Conventional EMR

ACTIVE COMPARATOR

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

Procedure: Conventional MER

Interventions

Precut EMR 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.

Precut-EMR

Conventional MER 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.

Conventional EMR

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-Gu, 05505, South Korea

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong-hoon Yang

  Asan Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: February 1, 2020
• First Posted: February 5, 2020
• Study Start: May 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)