Usefulness of Near-focus With Narrow-band Imaging

NCT ID: NCT02661945

Last Updated: 2019-06-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-08-31

Brief Summary

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Near-focus with narrow-band imaging is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with indio carmin spray, commonly used tool to determine tumor margin. The subject are patients who underwent endoscopic submucosal dissection for gastric neoplasms. Participants are randomized into near-focus with narrow-band imaging and indigo carmin groups. First, marking is performed at the tumor margins determined by each modality. The distance from the marking dots to the tumor margin is measured histopathologically in the resected specimens. Finally, the investigators will compare the accuracy between two groups based on the distance from marking dots to tumor margin measured by histopathologic examination.

Detailed Description

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Conditions

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Gastric Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Near focus with narrow band imaging

Near focus with narrow band imaging is used for marking the tumor margin.

Group Type EXPERIMENTAL

Near focus with narrow band imaging

Intervention Type DEVICE

Indigo carmin

After indigo carmine was sprayed over the lesion, marking is performed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Near focus with narrow band imaging

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants who undergo endoscopic submucosal dissection for gastric tumors (early gastric carcinoma or gastric adenoma)

Exclusion Criteria

* fail to en bloc resection
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyunghee University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jung-Wook Kim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cheonan Hospital, Soonchunhyang University College of Medicine

Cheonan, Chungcheongnam-do, South Korea

Site Status

Korea University Medical Center

Seoul, Seongbuk-gu, South Korea

Site Status

Inha University School of Medicine

Incheon, , South Korea

Site Status

Pusan National University School of Medicine

Pusan, , South Korea

Site Status

Kyung Hee University Hospital

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Soonchunhyang University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Nagahama T, Yao K, Maki S, Yasaka M, Takaki Y, Matsui T, Tanabe H, Iwashita A, Ota A. Usefulness of magnifying endoscopy with narrow-band imaging for determining the horizontal extent of early gastric cancer when there is an unclear margin by chromoendoscopy (with video). Gastrointest Endosc. 2011 Dec;74(6):1259-67. doi: 10.1016/j.gie.2011.09.005.

Reference Type BACKGROUND
PMID: 22136775 (View on PubMed)

Kiyotoki S, Nishikawa J, Satake M, Fukagawa Y, Shirai Y, Hamabe K, Saito M, Okamoto T, Sakaida I. Usefulness of magnifying endoscopy with narrow-band imaging for determining gastric tumor margin. J Gastroenterol Hepatol. 2010 Oct;25(10):1636-41. doi: 10.1111/j.1440-1746.2010.06379.x.

Reference Type RESULT
PMID: 20880172 (View on PubMed)

Kim JW, Jung Y, Jang JY, Kim GH, Bang BW, Park JC, Choi HS, Cho JH; Research Group for Endoscopic Instruments and Stents of Korean Society of Gastrointestinal Endoscopy. Narrowband imaging with near-focus magnification for discriminating the gastric tumor margin before endoscopic resection: A prospective randomized multicenter trial. J Gastroenterol Hepatol. 2020 Nov;35(11):1930-1937. doi: 10.1111/jgh.15109. Epub 2020 Jun 16.

Reference Type DERIVED
PMID: 32433790 (View on PubMed)

Other Identifiers

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NFNBI

Identifier Type: -

Identifier Source: org_study_id

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