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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435602
• Other study ID #: 506-1-09-01-14
• Status: Completed
• Phase: N/A
• First received: May 1, 2015
• Last updated: April 12, 2018
• Start date: December 2013
• Est. completion date: January 2017

Study information

• Verified date: April 2018
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Sklodowska - 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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Poland	Maria Sklodowska-curie Memorial Cancer Center, Institiute of Oncology	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology	Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive predictive value	The results of two methods are compare regarding positive predictive value.	2 years
Secondary	Duration of the esophagoscopy ( NBI versus Lugol staining)		2 years
Secondary	Evaluation of endoscopy ( NBI versus Lugol staining) tolerance using Visual Analogue Scale (VAS)		2 years