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

Endoscopic Surveillance Comparing Narrow Band Imaging (NBI) Against Lugol Chromoendoscopy for Detection of Synchronous Superficial Squamous Esophageal Neoplasia Among High Risk Patients

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

Study Overview

• Status: Completed
• Conditions: Superficial Esophageal Neoplasia

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 Type: Observational
• Enrollment (Actual): 180

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
NBI Magnify Endoscopy; Detection of esphageal neoplasia through recognition of brownish discolored area via NBI and characterize the lesion using IPCL upon magnifying endoscopy
Lugol Chromoendoscopy; Detection of esophageal neoplasia through recognition of discolored area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic accuracy of superficial esophageal neoplasia	1 month

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (ESTIMATE): December 6, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2006.077