Clinical trial NCT04170257: Performance of White Light, NBI and Iodine Staining Endoscopy in the Diagnosis of Esophageal Lesions
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Dysplasia of Esophagus
Moderate Dysplasia of Esophagus
Severe Dysplasia of Esophagus
Carcinoma in Situ of Esophagus
Esophageal Squamous Cell Carcinoma
Keywords: Esophageal Squamous Cell Carcinoma
Population-level screening
Narrow Band Imaging
Iodine Staining
Sensitivity and Specificity
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 10000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
timeFrame: 0 days
measure: Specificity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
timeFrame: 0 days
measure: Positive predictive value (PPV) of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
timeFrame: 0 days
measure: Negative predictive value (NPV) of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
timeFrame: 0 days
Secondary outcomes:
measure: Weight of each visualized abnormal feature of lesions
timeFrame: 0 days
measure: Discrimination of visualized abnormal features
timeFrame: 0 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Shantou
country: China
facility: Shantou University Medical College Affiliated Cancer Hospital
state: Guangdong
city: Anyang
country: China
facility: Anyang Cancer Hospital
state: Henan
city: Anyang
country: China
facility: People's Hospital of Hua County, Henan Province
state: Henan
city: Yinchuan
country: China
facility: People's Hospital of Ningxia Hui Autonomous Region
state: Ningxia Hui Autonomous Region
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Mengfei Liu, PhD
role: STUDY_DIRECTOR
References: