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

Not Applicable

Completed

• Conditions: Esophageal Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Head and Neck
• Interventions: Procedure: NBI endoscopy; Procedure: Lugol chromoendoscopy

• Registration Number: NCT02435602
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-06
• Primary Completion: 2016-11
• Study Completion: 2017-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBI endoscopy	NBI endoscopy	* 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.
lugol chromoendoscopy	Lugol chromoendoscopy	* 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.

Primary Outcome Measures

Name	Time	Method
Positive predictive value	2 years	The results of two methods are compare regarding positive predictive value.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maria Sklodowska-curie Memorial Cancer Center, Institiute of Oncology; 🇵🇱 Warsaw, Poland