Clinical trial · Interventional
Application of OE in Diagnosis of EGC
Application of OpticalEnhancement Endoscopy(OE) in Diagnosis of Early Gastric Cancer: a Multicenter, Prospective, Randomized Controlled 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 main purpose of this study is to evaluate application value of OE mode 2 in the diagnosis of early gastric cancer The Secondary purpose is to evaluate application value of OE mode 1 in differentiating the diagnosis of neoplastic lesions of the gastric mucosa.
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 |
|---|---|---|---|
| High Risk Population of Gastric Cancer | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OE+white light | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- OE+white light
- description
- Using white light firstly to observe from esophagus to duodenum and then switch OE mode to observe from antrum to esophagus.
- interventionNames
- Diagnostic Test: OE+white light
- type
- NO_INTERVENTION
- label
- White light
- description
- Using White light to observe from esophagus to duodenum.
Primary outcomes (1)
- measure
- Detection rate of gastric neoplastic lesion
- timeFrame
- procedure
- description
- Include early gastric cancer, high-grade neoplasia, low-grade neoplasia and adenoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Meet item 1or 2 + any items of 3-7 1. Male ≥ 40 years old, female ≥ 50 years old. 2. More than one year since the last gastroscopy. 3. Patients from the areas with high incidence of stomach cancer (Shandong Province, Liaoning Province, Fujian Province, Gansu Province, Qinghai Province, Ningxia Province, Jilin Province, Jiangsu Province, Shanghai). 4. Patients with pre-cancerous gastric diseases such as chronic atrophic gastritis, gastric ulcer, gastric polyp, hypertrophic gastritis, pernicious anemia, etc. in the past. 5. First-degree relatives of patients with a family history of gastric cancer. 6. Other high-risk life factors for gastric cancer (high salt, pickled diet, smoking, heavy alcohol consumption, etc.) 7. Positive serum gastric function tests (GastroPanel) include: H. pylori (H.P) antibody (+), Fasting pepsinogen I and II ratio (PG I/PGII) \<3.89, gastrin 17 (G-17) \>1.50 pmol/L. Exclusion Criteria: 1. Patients who have undergone invasive treatment such as surgical resection, PEG, chemotherapy etc. of either stomach or oesophagus. (except for EMR and ESD). 2. Patients with a confirmed diagnosis of progressive cancer above T2 degreed according to the TMN classification of cancer。 3. Patients on anticoagulants that cannot be biopsied. 4. Patients who have undergone gastrectomy. 5. Patients who have taken PPIs or H2 receptor antagonist within two weeks. 6. Patients with history of malignant neoplasm; high suspicion of neoplasm; severe cardiac, pulmonary, hepatic or renal insufficiency; severe mental illness and pregnant women. 7. Patients who did not signed the consent form.
References
Publications (2)
- RESULTGomez JM, Wang AY. Gastric intestinal metaplasia and early gastric cancer in the west: a changing paradigm. Gastroenterol Hepatol (N Y). 2014 Jun;10(6):369-78. PMID 25013389
- RESULTNagao M, Nishikawa J, Ogawa R, Sasaki S, Nakamura M, Nishimura J, Goto A, Hashimoto S, Okamoto T, Suenaga M, Hamamoto Y, Sakaida I. Evaluation of the Diagnostic Ability of Optical Enhancement System in Early Gastric Cancer Demarcation. Gastroenterol Res Pract. 2016;2016:2439621. doi: 10.1155/2016/2439621. Epub 2016 Sep 28. PMID 27774101