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

NCT ID: NCT02002559

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Superficial Esophageal Neoplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NBI Magnify Endoscopy

Detection of esphageal neoplasia through recognition of brownish discolored area via NBI and characterize the lesion using IPCL upon magnifying endoscopy

No interventions assigned to this group

Lugol Chromoendoscopy

Detection of esophageal neoplasia through recognition of discolored area

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Philip Wai Yan Chiu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip WY Chiu, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Other Identifiers

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2006.077

Identifier Type: -

Identifier Source: org_study_id

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