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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02435602

Enrollment

294

Registered

2015-05-06

Start date

2013-12-31

Completion date

2017-01-31

Last updated

2018-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

endoscopy, gastrointestinal, cancer screening

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.

Interventions

PROCEDURENBI endoscopy

GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy Biopsy at the visually abnormal lesions

PROCEDURELugol 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Positive predictive value	2 years	The results of two methods are compare regarding positive predictive value.

Secondary

Measure	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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026