Endoscopy Screening for Esophageal Cancer

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00927446
• Other study ID #: OMCP-98-006
• Status: Terminated
• Phase: Phase 4
• First received: June 22, 2009
• Last updated: October 18, 2010
• Start date: June 2009
• Est. completion date: April 2010

Study information

• Verified date: October 2010
• Source: Lotung Poh-Ai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Procedure:
• Endoscopy 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.

Locations

Country	Name	City	State
Taiwan	Lotung Poh-Ai Hospital	Yilan

Sponsors (1)

Lead Sponsor	Collaborator
Lotung Poh-Ai Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological interpretation of biopsy specimen for invasive cancer, carcinoma in-situ, or high-grade dysplasia		Within 3 days of endoscopy examination	No
Secondary	Pathological interpretation of biopsy specimen for any grade of dysplasia		within 3 days of endoscopy examination	No