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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Study of Anchoring-tip vs. Conventional EMR of Intermediate-Size Colorectal Polyps: Multi-center, Prospective, Randomized Controlled Trial

Conditions
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Colorectal Polyp

Intervention / Treatment
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* Procedure: Anchoring-tip vs. Conventional


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anchoring-tip EMR<br>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. | Procedure: Anchoring-tip vs. Conventional<br>* 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.<br>|
| Active Comparator: Conventional EMR<br>After injection of normal saline solution mix, snaring was tried for CEMR. | Procedure: Anchoring-tip vs. Conventional<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From EMR to reporting of histopathology, 1 month |