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Endoscopy Screening for Esophageal Cancer

This study has been terminated.
Sponsor:
Information provided by:
Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier:
NCT00927446
First received: June 22, 2009
Last updated: October 18, 2010
Last verified: October 2010
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pathological interpretation of biopsy specimen for any grade of dysplasia [ Time Frame: within 3 days of endoscopy examination ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hsing-Hong Chen/Superintendent, Lotung Poh-Ai hospital
ClinicalTrials.gov Identifier: NCT00927446     History of Changes
Other Study ID Numbers: OMCP-98-006
Study First Received: June 22, 2009
Last Updated: October 18, 2010
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Head and Neck Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013