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

NCT04825457 | Unknown

• 1 other identifier: 2020-10-008
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Polyp

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Anchoring-tip EMR

ACTIVE COMPARATOR

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

Conventional EMR

ACTIVE COMPARATOR

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

Procedure: Anchoring-tip vs. Conventional

Interventions

Anchoring-tip vs. Conventional PROCEDURE

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.

Anchoring-tip EMR; Conventional EMR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyungpook National University Chilgok Hospital: lead

Study Sites (1)

Joon Seop Lee

Daegu, 41404, South Korea

RECRUITING

Central Study Contacts

Joon Seop Lee, M.D., Ph.D.

CONTACT

+82-53-200-3084; coolsmurf@naver.com

Study Design

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

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: April 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)