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Endoscopy Screening for Esophageal Cancer

Endoscopy Screening for Esophageal Neoplasm With Narrow Band Imaging in Patients With Head and Neck Cancer: A Controlled Tandem Endoscopy Trial

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00927446
Enrollment
40
Registered
2009-06-25
Start date
2009-06-30
Completion date
2010-04-30
Last updated
2010-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

esophageal cancer, head and neck cancer, narrow band imaging, endoscopy, screening

Brief summary

Patients with head and neck cancer frequently develop synchronous or metachronous esophageal malignancies. Previous studies have demonstrated the efficacy of endoscopic screening for esophageal cancer in head and neck cancer patients. The Narrow Band Imaging (NBI) system, an optical technology that enhances the visualization of superficial vascular network, may be superior to the conventional white light endoscopy for the detection of neoplastic lesions. However, whether the application of NBI improves the detection results have not been critically evaluated. This study aims to investigate the diagnostic value of the NBI system in the endoscopic screening for esophageal neoplastic lesions in patients with head and neck cancer.

Detailed description

This is a prospective blinded controlled tandem endoscopy trial conducted in a regional medical center (Lotung Poh-Ai Hospital, Taiwan). Patients with tissue diagnosis of head and neck cancer are enrolled. Endoscopy screening for esophageal lesions is first performed by using the conventional white light system. Suspicious lesions are recorded. Then the entire esophagus is examined under the NBI system by another endoscopist, who is blinded to the result of the conventional endoscopy. After the endoscopic inspection completed, all suspicious lesions are biopsied. Before each procedure, which one of the two participating endoscopists applies the conventional or NBI system is randomized. The diagnostic rate of esophageal neoplasm by the conventional white light system and that of the NBI system are compared. The endpoint is the neoplastic lesion detected on endoscopic biopsy. We considered invasive cancer, carcinoma in-situ, and high-grade dysplasia (which usually cannot be distinguished from carcinoma in situ) as the primary points. Any dysplastic lesions were considered as secondary points.

Interventions

PROCEDUREEndoscopy screening with narrow band imaging

Narrow Band Imaging (NBI) system, an optical technology that enhances the visualization of superficial vascular network, may be superior to the conventional white light endoscopy for the detection of neoplastic lesions.

Sponsors

Lotung Poh-Ai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients with tissue diagnosis of head and neck cancer * histopathology of head and neck cancer is carcinoma (including squamous cell carcinoma, adenocarcinoma or undifferentiated) * aged more than 18 years old * agree to under go upper gastrointestinal endoscopy

Exclusion criteria

* lack of written informed consent * the origin of head and neck cancer is metastatic * histopathology of head and neck cancer is not carcinoma (e.g., sarcoma, lymphoma, etc) * incomplete upper gastrointestinal endoscopy

Design outcomes

Primary

MeasureTime frame
Pathological interpretation of biopsy specimen for invasive cancer, carcinoma in-situ, or high-grade dysplasiaWithin 3 days of endoscopy examination

Secondary

MeasureTime frame
Pathological interpretation of biopsy specimen for any grade of dysplasiawithin 3 days of endoscopy examination

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026