The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck

Intervention / Treatment
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* Procedure: NBI endoscopy
* Procedure: Lugol chromoendoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NBI endoscopy<br>GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy Biopsy at the visually abnormal lesions Pathologic examination of all biopsy tissue specimens Advises of endoscopic/surgical or oncological treatment will be given to participants who will be diagnosed with ESCC or high grade dysplasia of the esophagus. | Procedure: NBI endoscopy<br>* GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy Biopsy at the visually abnormal lesions<br>|
| Active Comparator: lugol chromoendoscopy<br>GI endoscopy examination and additional the entire length of esophagus is evaluate with Lugol chromoendoscopy Biopsy at the unstained lesions >= 5 mm diameter Pathologic examination of all biopsy tissue specimens Advises of endoscopic/surgical or oncological treatment will be given to participants who will be diagnosed with ESCC or high grade dysplasia of the esophagus. | Procedure: Lugol chromoendoscopy<br>* GI endoscopy examination and additional the entire length of esophagus is evaluate with Lugol chromoendoscopy Biopsy at the unstained lesions >= 5 mm diameter Pathologic examination of all biopsy tissue specimens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value | The results of two methods are compare regarding positive predictive value. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the esophagoscopy ( NBI versus Lugol staining) |  | 2 years | 
| Evaluation of endoscopy ( NBI versus Lugol staining) tolerance using Visual Analogue Scale (VAS) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopy, gastrointestinal, cancer screening