Performance of White Light, NBI and Iodine Staining Endoscopy in the Diagnosis of Esophageal Lesions

Esophageal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04170257
• Other study ID #: 2018KT111
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2019
• Source: Beijing Cancer Hospital
• Contact: Yang Ke, MD
• Phone: 86-10-88196762
• Email: keyang[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma in Situ
• Carcinoma in Situ of Esophagus
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Hyperplasia
• Mild Dysplasia of Esophagus
• Moderate Dysplasia of Esophagus
• Severe Dysplasia of Esophagus

Intervention

Diagnostic Test:
• Endoscopic examination using white light, NBI and iodine staining
Participants' esophagus will be examined by three commonly used diagnostic techniques in the order of : 1. White light endoscopy (WLE); 2. Narrow Band Imaging (NBI) and 3. Iodine Staining Endoscopy (ISE) with 1.2% Lugol's iodine solution. The required observation time is no less than 1 minute for WLE and 2 minutes for NBI and ISE. Endoscopic images of each participant are routinely captured at every 5 centimeters in the esophagus, and information is recorded in detail for each focal lesion. Biopsies are taken from all visually abnormal areas found by any one of the three techniques, histopathologic diagnoses are rendered by two pathologists according to standard criteria and discrepancies are adjudicated by consultation. The recorded endoscopic images for each biopsied lesion are read by two trained researchers and the visualized feature of lesions are decomposed into several indicators (e.g. size, shape, color, and border of lesions) .

Locations

Country	Name	City	State
China	Anyang Cancer Hospital	Anyang	Henan
China	People's Hospital of Hua County, Henan Province	Anyang	Henan
China	Beijing Friendship Hospital	Beijing	Beijing
China	Shantou University Medical College Affiliated Cancer Hospital	Shantou	Guangdong
China	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan	Ningxia Hui Autonomous Region

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus	Sensitivity of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.	0 days
Primary	Specificity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus	Specificity of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.	0 days
Primary	Positive predictive value (PPV) of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus	PPV of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.	0 days
Primary	Negative predictive value (NPV) of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus	NPV of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.	0 days
Secondary	Weight of each visualized abnormal feature of lesions	The estimated odds ratio of each decomposed graphic abnormal features of lesions, taking "severe dysplasia and above" diagnosed via histopathological analysis as the outcome events.	0 days
Secondary	Discrimination of visualized abnormal features	The area under the curve (AUC) of visualized graphic abnormal features for predicting severe dysplasia and above lesions.	0 days