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
About this trial
This is an interventional treatment trial for Colorectal Polyp
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.
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
NCT ID
NCT04825457
First Posted
March 29, 2021
Last Updated
March 29, 2021
Sponsor
Kyungpook National University Chilgok Hospital
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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