Clinical trial · Observational
Magnifying Endoscopy With Narrow Band Imaging Versus Endoscopic Ultrasonography for Prediction of Tumor Invasion Depth in Early Gastric Cancer: A Prospective Comparative Study
- 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)
The treatment of early gastric cancer can be divided into endoscopic resection and surgery, and the precise staging of early gastric cancer is very important to prevent unnecessary surgery or additional surgery after the procedure. The possibility of endoscopic resection is determined by the risk of lymph node metastasis. The risk factors of lymph node metastasis of early gastric cancer are lesion size, presence of ulceration, histologic differentiation, and depth of invasion. In contrast to other factors, the factor of invasion depth is relatively difficult to predict by using the conventional white light endoscopy (WLE). Therefore, the endoscopic ultrasonography (EUS) has been tried to use for prediction of the invasion depth. However, many studies reported that the accuracy of endoscopic ultrasonography for predicting the depth of invasion was varied. A system consisting of a magnifying endoscope combined with narrow-band imaging (NBI), with the spectral band width narrowed by optical filters, was developed to enhance visualization of mucosal surface structure and vascular architecture. There were some reports that the magnifying endoscopy with narrow band imaging (ME-NBI) is superior to predict the histologic differentiation, depth of invasion and lesion margin than WLE. In this study, we divide the patients with suspected early gastric cancer (EGC) into the two groups as group using conventional WLE and EUS and group using WLE and ME-NBI, and try to compare the accuracy of EUS and ME-NBI for predicting the invasion depth of EGC. We also try to analyze the factors that affect the accuracy for predicting of depth such as characteristics of cancer lesion and histologic differentiation of cancer in each group. In addition, we try to analyze the characteristic imaging findings of ME-NBI for early gastric cancer and gastric adenoma and evaluate the efficacy of ME-NBI for early gastric cancer and gastric adenoma diagnosis.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
| Gastric Adenoma | Gastric Adenoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| magnifying endoscopy with narrow band imaging (ME-NBI) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- EUS
- description
- group using conventional WLE and EUS
- label
- ME-NBI
- description
- group using WLE and ME-NBI.
- interventionNames
- Device: magnifying endoscopy with narrow band imaging (ME-NBI)
Primary outcomes (1)
- measure
- the accuracy in predicting the invasion depth of EGC.
- timeFrame
- Within 1 month after lesion resection
- description
- To compare the accuracy of EUS and ME-NBI in predicting the invasion depth of EGC using final pathology result.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults over 19 years of age 2. Patients who are diagnosed gastric adenoma or early gastric cancer by esophagogastroduodenoscopy and are planning endoscopic resection or surgical resection for cure. 3. Patients who understand that they have the right to sign the consent form prior to the initiation of treatment and to withdraw from the clinical trial without penalty at any time. Exclusion Criteria: 1. Failed to obtain informed consent of the patient or guardian. 2. Anyone deemed inappropriate by the researchers or the primary care physician in clinical studies. 3. Women who are pregnant and possibly pregnant or breastfeeding
References
Publications (14)
- RESULTChoi J, Kim SG, Im JP, Kim JS, Jung HC, Song IS. Endoscopic prediction of tumor invasion depth in early gastric cancer. Gastrointest Endosc. 2011 May;73(5):917-27. doi: 10.1016/j.gie.2010.11.053. Epub 2011 Feb 11. PMID 21316050
- RESULTPei Q, Wang L, Pan J, Ling T, Lv Y, Zou X. Endoscopic ultrasonography for staging depth of invasion in early gastric cancer: A meta-analysis. J Gastroenterol Hepatol. 2015 Nov;30(11):1566-73. doi: 10.1111/jgh.13014. PMID 26094975
- RESULTKwee RM, Kwee TC. The accuracy of endoscopic ultrasonography in differentiating mucosal from deeper gastric cancer. Am J Gastroenterol. 2008 Jul;103(7):1801-9. doi: 10.1111/j.1572-0241.2008.01923.x. Epub 2008 Jun 28. PMID 18564110
- RESULTSerrano OK, Huang K, Ng N, Yang J, Friedmann P, Libutti SK, Kennedy TJ. Correlation between preoperative endoscopic ultrasound and surgical pathology staging of gastric adenocarcinoma: A single institution retrospective review. J Surg Oncol. 2016 Jan;113(1):42-5. doi: 10.1002/jso.24098. Epub 2016 Jan 19. PMID 26784562
- RESULTGono K. Narrow Band Imaging: Technology Basis and Research and Development History. Clin Endosc. 2015 Nov;48(6):476-80. doi: 10.5946/ce.2015.48.6.476. Epub 2015 Nov 30. PMID 26668792
- RESULTHayee B, Inoue H, Sato H, Santi EG, Yoshida A, Onimaru M, Ikeda H, Kudo SE. Magnification narrow-band imaging for the diagnosis of early gastric cancer: a review of the Japanese literature for the Western endoscopist. Gastrointest Endosc. 2013 Sep;78(3):452-61. doi: 10.1016/j.gie.2013.03.1333. Epub 2013 Apr 28. No abstract available. PMID 23632326
- RESULTKikuchi D, Iizuka T, Hoteya S, Yamada A, Furuhata T, Yamashita S, Domon K, Nakamura M, Matsui A, Mitani T, Ogawa O, Watanabe S, Kaise M. Usefulness of magnifying endoscopy with narrow-band imaging for determining tumor invasion depth in early gastric cancer. Gastroenterol Res Pract. 2013;2013:217695. doi: 10.1155/2013/217695. Epub 2013 Jan 17.