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

Last updated: November 18, 2019
Sponsor: Beijing Cancer Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Cancer

Esophageal Disorders

Genitourinary Cancer

Treatment

N/A

Clinical Study ID

NCT04170257
2018KT111
  • Ages 45-69
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Patients seek for endoscopic examinations at the endoscopy center in any of the fivehospitals included in this study

  • Aged 45-69 years

  • Have entire esophagus

  • Provide written informed consent and leave personal identification and contactinformation

Exclusion

Exclusion Criteria:

  • Have contraindications to endoscopic examination (Including but not limited to severearrhythmia, myocardial infarction, heart failure, hemiplegia, asthma, severehypertension (≥ 180 / 110mmHg), psychosis, etc )

  • Have a history of drug allergy

  • Have a history of upper gastrointestinal surgery

  • Have a history of radiotherapy or chemotherapy

Study Design

Total Participants: 10000
Study Start date:
October 18, 2019
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • Beijing Friendship Hospital

    Beijing, Beijing 100050
    China

    Site Not Available

  • Shantou University Medical College Affiliated Cancer Hospital

    Shantou, Guangdong
    China

    Site Not Available

  • Anyang Cancer Hospital

    Anyang, Henan 455000
    China

    Active - Recruiting

  • People's Hospital of Hua County, Henan Province

    Anyang, Henan 456400
    China

    Active - Recruiting

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia Hui Autonomous Region
    China

    Site Not Available

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