Clinical trial · Interventional
Usefulness of Near-focus With Narrow-band Imaging
Usefulness of Near-focus With Narrow-band Imaging for Determining Gastric Tumor Margin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Tumors | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Near focus with narrow band imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Near focus with narrow band imaging
- description
- Near focus with narrow band imaging is used for marking the tumor margin.
- interventionNames
- Device: Near focus with narrow band imaging
- type
- NO_INTERVENTION
- label
- Indigo carmin
- description
- After indigo carmine was sprayed over the lesion, marking is performed.
Primary outcomes (1)
- measure
- Accuracy (accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm)
- timeFrame
- 1 week after procedure
- description
- Marking was diagnosed as accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Participants who undergo endoscopic submucosal dissection for gastric tumors (early gastric carcinoma or gastric adenoma) Exclusion Criteria: * fail to en bloc resection
References
Publications (3)
- BACKGROUNDNagahama T, Yao K, Maki S, Yasaka M, Takaki Y, Matsui T, Tanabe H, Iwashita A, Ota A. Usefulness of magnifying endoscopy with narrow-band imaging for determining the horizontal extent of early gastric cancer when there is an unclear margin by chromoendoscopy (with video). Gastrointest Endosc. 2011 Dec;74(6):1259-67. doi: 10.1016/j.gie.2011.09.005. PMID 22136775
- RESULTKiyotoki S, Nishikawa J, Satake M, Fukagawa Y, Shirai Y, Hamabe K, Saito M, Okamoto T, Sakaida I. Usefulness of magnifying endoscopy with narrow-band imaging for determining gastric tumor margin. J Gastroenterol Hepatol. 2010 Oct;25(10):1636-41. doi: 10.1111/j.1440-1746.2010.06379.x. PMID 20880172
- DERIVEDKim JW, Jung Y, Jang JY, Kim GH, Bang BW, Park JC, Choi HS, Cho JH; Research Group for Endoscopic Instruments and Stents of Korean Society of Gastrointestinal Endoscopy. Narrowband imaging with near-focus magnification for discriminating the gastric tumor margin before endoscopic resection: A prospective randomized multicenter trial. J Gastroenterol Hepatol. 2020 Nov;35(11):1930-1937. doi: 10.1111/jgh.15109. Epub 2020 Jun 16. PMID 32433790