Usefulness of Near-focus With Narrow-band Imaging

Kyung Hee University

Status: Completed

Conditions: Gastric Tumors

Treatments: Device: Near focus with narrow band imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02661945

NFNBI

Details and patient eligibility

About

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.

Enrollment: 444 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• fail to en bloc resection

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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444 participants in 2 patient groups

Near focus with narrow band imaging

Experimental group

Description:

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

Treatment:

Device: Near focus with narrow band imaging

Indigo carmin

No Intervention group

Description:

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