Narrow Band Imaging (NBI) Against Lugol for Squamous Esophageal Cancer

Completed

• Conditions: Superficial Esophageal Neoplasia

• Registration Number: NCT02002559
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This study aimed to compare Narrow Band Imaging (NBI) against Lugol chromoendoscopy for diagnosis of early esophageal cancers among high risk patients.

Detailed Description

The investigators recruited consecutive patients with head and neck cancers, history of squamous esophageal cancers treated by chemoradiotherapy or endoscopic resection. Endoscopic surveillance first started with NBI for detection and characterization of early esophageal cancers through observation of abnormal intrapapillary capillary loops (IPCL). Superficial esophageal neoplasia were diagnosed by IPCL Type IV, V1,V2 and Vn. Lugol chromoendoscopy would be performed subsequently and suspicious neoplasia were classified as understain or unstain lesions. The diagnostic accuracy, sensitivity and specificity of NBI were compared to Lugol chromoendoscopy with histology serving as a gold standard.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Patients with Head and Neck Cancer
2. Patients with esophageal cancer treated by chemoradiotherapy and in remission for 2 years
3. Patients with esophageal cancer treated by endoscopic resection
4. Age 18 to 80

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Exclusion Criteria

1. Allergy to Lugol iodine
2. Pregnancy
3. Previous esophagectomy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of superficial esophageal neoplasia	1 month