The Role of Narrow Band Imaging (NBI) Endoscopy Compared With Lugol Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers: a Prospective Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Esophageal Squamous Cell Carcinoma
- Sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Enrollment
- 294
- Locations
- 1
- Primary Endpoint
- Positive predictive value
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study evaluates the role of narrow band imaging (NBI) endoscopy compared with Lugol chromoendoscopy in the early detection of esophageal cancer in patients with prior head and neck cancers.
Detailed Description
Patients with head and neck cancers have an increased risk for developing an esophageal squamous cell carcinoma (ESCC). Small, superficial, curable lesions are difficult to diagnose using only white light endoscopy. To improve detection chromoendoscopy is recommended. In this project patients are divided into two groups based on received chromoendoscopy (NBI versus Lugol). The results of two methods will be compare regarding positive predictive value to establish usage of chromoendoscopy in early detection of ESCC.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with past history ( \>= 1 year ) of head and neck cancer treated curatively and receiving regular follow - up at the outpatient clinic of the Head and Neck Department of Maria Skłodowska - Curie Memorial Cancer Center, Institiut of Oncology
- •18 years and older
- •Diagnosis of squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx
- •Zubrod scale 0-2
- •Provided written informed consent
Exclusion Criteria
- •Lack of written informed consent
- •Known allergy to iodine
- •Clinical conditions precluding upper GI endoscopy
Outcomes
Primary Outcomes
Positive predictive value
Time Frame: 2 years
The results of two methods are compare regarding positive predictive value.
Secondary Outcomes
- Evaluation of endoscopy ( NBI versus Lugol staining) tolerance using Visual Analogue Scale (VAS)(2 years)
- Duration of the esophagoscopy ( NBI versus Lugol staining)(2 years)