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OpenTrials
Completed

NCT Number: NCT02661945

Usefulness of Near-focus With Narrow-band Imaging

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Chungcheongnam-do, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • fail to en bloc resection

Treatment and study plan

Near focus with narrow band imaging

Device

Primary outcomes

  1. Accuracy (accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm)

    Time frame: 1 week after procedure

    Marking was diagnosed as accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Registry information

Official study title

Usefulness of Near-focus With Narrow-band Imaging for Determining Gastric Tumor Margin

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 25, 2016
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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