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Endoscopy Screening for Esophageal Cancer

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00927446
First Posted: June 25, 2009
Last Update Posted: October 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lotung Poh-Ai Hospital
  Purpose

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
Head and Neck Cancer Procedure: Endoscopy screening with narrow band imaging Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

Resource links provided by NLM:


Further study details as provided by Lotung Poh-Ai Hospital:

Primary Outcome Measures:
  • Pathological interpretation of biopsy specimen for invasive cancer, carcinoma in-situ, or high-grade dysplasia [ Time Frame: Within 3 days of endoscopy examination ]

Secondary Outcome Measures:
  • Pathological interpretation of biopsy specimen for any grade of dysplasia [ Time Frame: within 3 days of endoscopy examination ]

Biospecimen Retention:   Samples Without DNA
endoscopic biopsy for histopathological examination

Estimated Enrollment: 40
Study Start Date: June 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.
Other Name: NBI

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with tissue diagnosis of head and neck carcinoma
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927446


Locations
Taiwan
Lotung Poh-Ai Hospital
Yilan, Taiwan, 265
Sponsors and Collaborators
Lotung Poh-Ai Hospital
Investigators
Principal Investigator: Tzeng-Huey Yang, M.D. Lotung Poh-Ai Hospital
  More Information

Responsible Party: Hsing-Hong Chen/Superintendent, Lotung Poh-Ai hospital
ClinicalTrials.gov Identifier: NCT00927446     History of Changes
Other Study ID Numbers: OMCP-98-006
First Submitted: June 22, 2009
First Posted: June 25, 2009
Last Update Posted: October 19, 2010
Last Verified: October 2010

Keywords provided by Lotung Poh-Ai Hospital:
esophageal cancer
head and neck cancer
narrow band imaging
endoscopy
screening

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms