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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Notify MeKey information
Conditions
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
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
Primary outcomes
-
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.
View the official ClinicalTrials.gov record (opens in a new tab)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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