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

NCT ID: NCT04825457

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2022-03-31

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.

Conditions

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Colorectal Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Anchoring-tip vs. Conventional

Intervention Type 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.

Conventional EMR

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

Group Type ACTIVE_COMPARATOR

Anchoring-tip vs. Conventional

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kyungpook National University Chilgok Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joon Seop Lee

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Joon Seop Lee

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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

Role: CONTACT

+82-53-200-3084

Facility Contacts

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

Role: primary

+82-53-200-3084

Other Identifiers

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2020-10-008

Identifier Type: -

Identifier Source: org_study_id

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