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

Superficial Esophageal Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002559
• Other study ID #: 2006.077
• Status: Completed
• Start date: April 2006
• Est. completion date: December 2010

Study information

• Verified date: July 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Superficial Esophageal Neoplasia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of superficial esophageal neoplasia		1 month