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

• ClinicalTrials.gov Identifier: NCT04825457
• Recruitment Status: Recruiting
• First Posted: April 1, 2021
• Last Update Posted: April 1, 2021
• Sponsor: Kyungpook National University Chilgok Hospital
• Information provided by (Responsible Party): Joon Seop Lee, Kyungpook National University Chilgok Hospital

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Polyp	Procedure: Anchoring-tip vs. Conventional	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Comparative Study of Anchoring-tip vs. Conventional EMR of Intermediate-Size Colorectal Polyps: Multi-center, Prospective, Randomized Controlled Trial
• Estimated Study Start Date: April 2021
• Estimated Primary Completion Date: March 2022
• Estimated Study Completion Date: March 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Anchoring-tip EMR; 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; 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.
Active Comparator: Conventional EMR; After injection of normal saline solution mix, snaring was tried for CEMR.	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.

Outcome Measures

Primary Outcome Measures :

1. Primary outcome was comparing the R0 resection rate between Anchoring-tip EMR and Conventional EMR. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: Joon Seop Lee, M.D., Ph.D.; +82-53-200-3084; coolsmurf@naver.com

Locations

Korea, Republic of

Joon Seop Lee; Recruiting

Daegu, Korea, Republic of, 41404

Contact: Joon Seop Lee, M.D., Ph.D. +82-53-200-3084 coolsmurf@naver.com

Sponsors and Collaborators

Kyungpook National University Chilgok Hospital

More Information

• Responsible Party: Joon Seop Lee, Clinical Assistant Professor, Kyungpook National University Chilgok Hospital
• ClinicalTrials.gov Identifier: NCT04825457
• Other Study ID Numbers: 2020-10-008
• First Posted: April 1, 2021
• Last Update Posted: April 1, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Polyps; Pathological Conditions, Anatomical