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

Maria Sklodowska-Curie National Research Institute of Oncology

Status: Completed

Conditions: Squamous Cell Carcinoma of the Head and Neck; Esophageal Squamous Cell Carcinoma

Treatments: Procedure: NBI endoscopy; Procedure: Lugol chromoendoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02435602

506-1-09-01-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 294 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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294 participants in 2 patient groups

NBI endoscopy

Active Comparator group

Description:

* 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.

Treatment:

Procedure: NBI endoscopy

lugol chromoendoscopy

Active Comparator group

Description:

* 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.

Treatment:

Procedure: Lugol chromoendoscopy