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Comparative Study of Anchoring-tip vs. Conventional EMR of Colorectal Polyps

Primary Purpose

Colorectal Polyp

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Anchoring-tip vs. Conventional
Sponsored by
Kyungpook National University Chilgok Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Polyp

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Intermediate-size (10 to 20 mm) colorectal polyps
  • Morphologically sessile (Is), slightly elevated (IIa), flat (IIb), and slightly depressed (IIc) as Paris classification of superficial neoplastic lesions
  • Laterally spreading tumor (granular and nongranular type) as Kudo classification.

Exclusion Criteria:

  • Pedunculated or excavated/ulcerated polyps
  • Polyps with features strongly suggestive of submucosal invasive carcinoma
  • Polyps in patients with inflammatory bowel disease, familial polyposis, electrolyte abnormality, and coagulopathy
  • Residual lesions after endoscopic resection or presence of severe submucosal fibrosis.

Sites / Locations

  • Joon Seop LeeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Anchoring-tip EMR

Conventional EMR

Arm Description

AEMR, the snare tip was projected from the sheath by 1-2 mm length. Consequently, a small mucosal incision was made at proximal side of lesion. Then the snare was deployed progressively and adjusted around the lesion trying to obtain free margins.

After injection of normal saline solution mix, snaring was tried for CEMR.

Outcomes

Primary Outcome Measures

Primary outcome was comparing the R0 resection rate between Anchoring-tip EMR and Conventional EMR.
Histopathologic complete resection (R0) was defined as en bloc resection and clear lateral and vertical resection margins.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2021
Last Updated
March 29, 2021
Sponsor
Kyungpook National University Chilgok Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04825457
Brief Title
Comparative Study of Anchoring-tip vs. Conventional EMR of Colorectal Polyps
Official Title
Comparative Study of Anchoring-tip vs. Conventional EMR of Intermediate-Size Colorectal Polyps: Multi-center, Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Chilgok Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Endoscopic mucosal resection (EMR) is an effective and has been widely used technique for the treatment of superficial colorectal neoplasms. Although, conventional EMR (CEMR) showed high efficacy for the management of colorectal superficial neoplasms, there is problematic limitation in this technique - incomplete resection. In literature, the anchoring-tip EMR (AEMR), named as "Tip-in EMR" was first introduced in 2016 from Japan. Recently, several retrospective studies have been suggested about the effectiveness of AEMR. However, there has been no prospective randomized controlled study to identify its advantage over CEMR. Therefore, the investigators performed a multicenter randomized controlled trial to estimate the effectiveness of AEMR compared with CEMR for the endoscopic treatment of intermediate-size (10 to 20 mm) colorectal polyps.
Detailed Description
After injection of normal saline solution mix, snaring was tried for CEMR. In AEMR, the snare tip was projected from the sheath by 1-2 mm length. Consequently, a small mucosal incision was made at proximal side of lesion. Then the snare was deployed progressively and adjusted around the lesion trying to obtain free margins. At the final step of both conventional and Tip-in EMR, the lesion was resected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyp

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anchoring-tip EMR
Arm Type
Active Comparator
Arm Description
AEMR, the snare tip was projected from the sheath by 1-2 mm length. Consequently, a small mucosal incision was made at proximal side of lesion. Then the snare was deployed progressively and adjusted around the lesion trying to obtain free margins.
Arm Title
Conventional EMR
Arm Type
Active Comparator
Arm Description
After injection of normal saline solution mix, snaring was tried for CEMR.
Intervention Type
Procedure
Intervention Name(s)
Anchoring-tip vs. Conventional
Intervention Description
Anchoring-tip: the snare tip was projected from the sheath by 1-2 mm length. Consequently, a small mucosal incision was made at proximal side of lesion. Then the snare was deployed progressively and adjusted around the lesion trying to obtain free margins. At the final step of both conventional and Tip-in EMR, the lesion was resected. Conventional: After injection of normal saline solution mix, snaring was tried for polyp resection.
Primary Outcome Measure Information:
Title
Primary outcome was comparing the R0 resection rate between Anchoring-tip EMR and Conventional EMR.
Description
Histopathologic complete resection (R0) was defined as en bloc resection and clear lateral and vertical resection margins.
Time Frame
From EMR to reporting of histopathology, 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Intermediate-size (10 to 20 mm) colorectal polyps Morphologically sessile (Is), slightly elevated (IIa), flat (IIb), and slightly depressed (IIc) as Paris classification of superficial neoplastic lesions Laterally spreading tumor (granular and nongranular type) as Kudo classification. Exclusion Criteria: Pedunculated or excavated/ulcerated polyps Polyps with features strongly suggestive of submucosal invasive carcinoma Polyps in patients with inflammatory bowel disease, familial polyposis, electrolyte abnormality, and coagulopathy Residual lesions after endoscopic resection or presence of severe submucosal fibrosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joon Seop Lee, M.D., Ph.D.
Phone
+82-53-200-3084
Email
coolsmurf@naver.com
Facility Information:
Facility Name
Joon Seop Lee
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon Seop Lee, M.D., Ph.D.
Phone
+82-53-200-3084
Email
coolsmurf@naver.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparative Study of Anchoring-tip vs. Conventional EMR of Colorectal Polyps

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