Clinical trial · Interventional
Performance of White Light, NBI and Iodine Staining Endoscopy in the Diagnosis of Esophageal Lesions
Performance of White Light, Narrow Band Imaging and Iodine Staining Endoscopy in the Diagnosis of Esophageal Squamous Epithelium Lesions: A Multicenter Clinical Study in China
- 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 investigators aim to evaluate the performance of Narrow Band Imaging (NBI) endoscopy in Esophageal Squamous Cell Carcinoma (ESCC) screening, as compared to the currently used White Light Endoscopy (WLE) and Lugol's Iodine Staining Endoscopy (ISE). NBI is a simple, safe and non-invasive technique, which can provide real-time optical staining for suspicious lesions. This trial is designated to enroll 10000 participants from five centers located in different regions (North, West and South) in China, which would provide real-world evidence for the recommendation of endoscopic diagnostic technique used in ESCC screening projects.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma in Situ of Esophagus | — | UNRESOLVED | — |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Mild Dysplasia of Esophagus | — | UNRESOLVED | — |
| Moderate Dysplasia of Esophagus | — | UNRESOLVED | — |
| Severe Dysplasia of Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic examination using white light, NBI and iodine staining | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Opportunistic screening cohort
- description
- This opportunistic screening cohort is constructed among patients aged 45-69 years who undergo endoscopic examinations at the endoscopy center in any of the five hospitals included in this study. Enrolled participants are requested to complete a computer aided one-on-one questionnaire regarding demographic factors, smoking and alcohol drinking status, dietary habits，digestive tract symptoms and family history of ESCC. Then experienced endoscopists will perform the upper gastrointestinal endoscopic examination for each participant, and the entire esophagus will be visually examined with the white light, NBI and iodine staining endoscopic examination.
- interventionNames
- Diagnostic Test: Endoscopic examination using white light, NBI and iodine staining
Primary outcomes (4)
- measure
- Sensitivity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
- timeFrame
- 0 days
- description
- Sensitivity of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Patients seek for endoscopic examinations at the endoscopy center in any of the five hospitals included in this study * Aged 45-69 years * Have entire esophagus * Provide written informed consent and leave personal identification and contact information Exclusion Criteria: * Have contraindications to endoscopic examination (Including but not limited to severe arrhythmia, myocardial infarction, heart failure, hemiplegia, asthma, severe hypertension (≥ 180 / 110mmHg), psychosis, etc ) * Have a history of drug allergy * Have a history of upper gastrointestinal surgery * Have a history of radiotherapy or chemotherapy
References
Publications (0)
Data not yet available