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

Not Applicable

• Conditions: Colorectal Polyp
• Interventions: Procedure: Anchoring-tip vs. Conventional

• Registration Number: NCT04825457
• Lead Sponsor: Kyungpook National University Chilgok Hospital

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.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Last Update Submitted: 2021-03-29
• Study Start: 2021-04
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anchoring-tip EMR	Anchoring-tip vs. Conventional	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.
Conventional EMR	Anchoring-tip vs. Conventional	After injection of normal saline solution mix, snaring was tried for CEMR.

Primary Outcome Measures

Name	Time	Method
Primary outcome was comparing the R0 resection rate between Anchoring-tip EMR and Conventional EMR.	From EMR to reporting of histopathology, 1 month	Histopathologic complete resection (R0) was defined as en bloc resection and clear lateral and vertical resection margins.

Trial Locations

Locations (1)

Joon Seop Lee; 🇰🇷 Daegu, Korea, Republic of