Usefulness of Near-focus With Narrow-band Imaging
- Conditions
- Gastric Tumors
- Interventions
- Device: Near focus with narrow band imaging
- Registration Number
- NCT02661945
- Lead Sponsor
- Kyunghee University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 444
- Participants who undergo endoscopic submucosal dissection for gastric tumors (early gastric carcinoma or gastric adenoma)
- fail to en bloc resection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Near focus with narrow band imaging Near focus with narrow band imaging Near focus with narrow band imaging is used for marking the tumor margin.
- Primary Outcome Measures
Name Time Method Accuracy (accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Cheonan Hospital, Soonchunhyang University College of Medicine
🇰🇷Cheonan, Chungcheongnam-do, Korea, Republic of
Inha University School of Medicine
🇰🇷Incheon, Korea, Republic of
Korea University Medical Center
🇰🇷Seoul, Seongbuk-gu, Korea, Republic of
Pusan National University School of Medicine
🇰🇷Pusan, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Hospital
🇰🇷Seoul, Korea, Republic of