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Sponsored by: |
Lotung Poh-Ai Hospital |
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Information provided by: | Lotung Poh-Ai Hospital |
ClinicalTrials.gov Identifier: | NCT00927446 |
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.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Procedure: Endoscopy screening with narrow band imaging |
Phase IV |
Study Type: | Observational |
Study Design: | Cohort, Cross-Sectional |
Official Title: | Endoscopy Screening for Esophageal Neoplasm With Narrow Band Imaging in Patients With Head and Neck Cancer: A Controlled Tandem Endoscopy Trial |
endoscopic biopsy for histopathological examination
Estimated Enrollment: | 40 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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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.
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with tissue diagnosis of head and neck carcinoma
Inclusion Criteria:
Exclusion Criteria:
Contact: Yao-Chun Hsu, M.D.,Msc | 886-3-9509579 | holdenhsu@ntu.edu.tw |
Taiwan | |
Lotung Poh-Ai Hospital | Recruiting |
Yilan, Taiwan, 265 | |
Contact: Yao-Chun Hsu, M.D.,Msc 886-3-9509579 holdenhsu@ntu.edu.tw |
Principal Investigator: | Tzeng-Huey Yang, M.D. | Lotung Poh-Ai Hospital |
Responsible Party: | Lotung Poh-Ai hospital ( Hsing-Hong Chen/Superintendent ) |
Study ID Numbers: | OMCP-98-006 |
Study First Received: | June 22, 2009 |
Last Updated: | June 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00927446 History of Changes |
Health Authority: | Taiwan: Department of Health |
esophageal cancer head and neck cancer narrow band imaging endoscopy screening |
Digestive System Diseases Digestive System Neoplasms Esophageal Disorder Gastrointestinal Diseases Esophageal Neoplasms |
Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Cancer Esophageal Diseases |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases |
Head and Neck Neoplasms Esophageal Neoplasms Gastrointestinal Neoplasms Esophageal Diseases |