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

Colorectal Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04825457
• Other study ID #: 2020-10-008
• Status: Recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: March 2022

Study information

• Verified date: March 2021
• Source: Kyungpook National University Chilgok Hospital
• Contact: Joon Seop Lee, M.D., Ph.D.
• Phone: +82-53-200-3084
• Email: coolsmurf[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Polyp
• Polyps

Intervention

Procedure:
• Anchoring-tip vs. Conventional
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.

Locations

Country	Name	City	State
Korea, Republic of	Joon Seop Lee	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University Chilgok Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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