Back to resultsThe Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers
Primary Purpose
Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
NBI endoscopy
Lugol chromoendoscopy
Sponsored by
About this trial
This is an interventional screening trial for Esophageal Squamous Cell Carcinoma focused on measuring endoscopy, gastrointestinal, cancer screening
Eligibility Criteria
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
Sites / Locations
- Maria Sklodowska-curie Memorial Cancer Center, Institiute of Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
NBI endoscopy
lugol chromoendoscopy
Arm 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.
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.
Outcomes
Primary Outcome Measures
Positive predictive value
The results of two methods are compare regarding positive predictive value.
Secondary Outcome Measures
Duration of the esophagoscopy ( NBI versus Lugol staining)
Evaluation of endoscopy ( NBI versus Lugol staining) tolerance using Visual Analogue Scale (VAS)
Full Information
NCT ID
NCT02435602
First Posted
May 1, 2015
Last Updated
April 12, 2018
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Centre of Postgraduate Medical Education
1. Study Identification
Unique Protocol Identification Number
NCT02435602
Brief Title
The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Centre of Postgraduate Medical Education
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck
Keywords
endoscopy, gastrointestinal, cancer screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
294 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NBI endoscopy
Arm Type
Active Comparator
Arm 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.
Arm Title
lugol chromoendoscopy
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
NBI endoscopy
Intervention Description
GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy Biopsy at the visually abnormal lesions
Intervention Type
Procedure
Intervention Name(s)
Lugol chromoendoscopy
Intervention 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
Primary Outcome Measure Information:
Title
Positive predictive value
Description
The results of two methods are compare regarding positive predictive value.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Duration of the esophagoscopy ( NBI versus Lugol staining)
Time Frame
2 years
Title
Evaluation of endoscopy ( NBI versus Lugol staining) tolerance using Visual Analogue Scale (VAS)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaroslaw Regula, PhD
Organizational Affiliation
Maria Sklodowska-Curie Memorial Cancer Center, Institiute of Oncology, Warsaw, Poland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anna Chaber-Ciopinska, MD
Organizational Affiliation
Maria Sklodowska-Curie Memorial Cancer Center, Institiute of Oncology, Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Sklodowska-curie Memorial Cancer Center, Institiute of Oncology
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers
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