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Usefulness of Near-focus With Narrow-band Imaging

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02661945
Enrollment
444
Registered
2016-01-25
Start date
2015-07-31
Completion date
2017-08-31
Last updated
2019-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Tumors

Keywords

near focus with narrow band imaging, tumor margin, indigocarmine chromoendoscopy

Brief summary

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.

Interventions

DEVICENear focus with narrow band imaging

Sponsors

Kyunghee University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* fail to en bloc resection

Design outcomes

Primary

MeasureTime frameDescription
Accuracy (accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm)1 week after procedureMarking was diagnosed as accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026