Endoscopy Screening for Esophageal Cancer

NCT00927446 | Terminated DMC

• 1 other identifier: OMCP-98-006
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pathological interpretation of biopsy specimen for invasive cancer, carcinoma in-situ, or high-grade dysplasia

  Within 3 days of endoscopy examination

Secondary Outcomes (1)

• Pathological interpretation of biopsy specimen for any grade of dysplasia

  within 3 days of endoscopy examination

Study Arms (1)

Endoscopy screening

Patients with tissue diagnosis of head and neck cancer undergo endoscopy screening with conventional white light system first. Then the entire esophagus is examined under the NBI system by another endoscopist, who is blinded to the result of the conventional endoscopy.

Procedure: Endoscopy screening with narrow band imaging

Interventions

Endoscopy screening with narrow band imaging PROCEDURE

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.

Also known as: NBI

Endoscopy screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with tissue diagnosis of head and neck carcinoma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lotung Poh-Ai Hospital: lead

Study Sites (1)

Lotung Poh-Ai Hospital

Yilan, 265, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

endoscopic biopsy for histopathological examination

MeSH Terms

Conditions

Head and Neck Neoplasms; Esophageal Neoplasms

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Tzeng-Huey Yang, M.D.

  Lotung Poh-Ai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 25, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 19, 2010

Record last verified: 2010-10

Locations

TW (1)