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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435602
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
Centre of Postgraduate Medical Education
Information provided by (Responsible Party):
Maria Sklodowska-Curie Institute - Oncology Center

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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Squamous Cell Carcinoma of the Head and Neck Procedure: NBI endoscopy Procedure: Lugol chromoendoscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
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
Actual Study Start Date : December 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017


Arm Intervention/treatment
Active Comparator: 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.
Procedure: NBI endoscopy
GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy Biopsy at the visually abnormal lesions

Active Comparator: 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.
Procedure: 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




Primary Outcome Measures :
  1. Positive predictive value [ Time Frame: 2 years ]
    The results of two methods are compare regarding positive predictive value.


Secondary Outcome Measures :
  1. Duration of the esophagoscopy ( NBI versus Lugol staining) [ Time Frame: 2 years ]
  2. Evaluation of endoscopy ( NBI versus Lugol staining) tolerance using Visual Analogue Scale (VAS) [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435602


Locations
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Poland
Maria Sklodowska-curie Memorial Cancer Center, Institiute of Oncology
Warsaw, Poland, 02-781
Sponsors and Collaborators
Maria Sklodowska-Curie Institute - Oncology Center
Centre of Postgraduate Medical Education
Investigators
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Study Director: Jaroslaw Regula, PhD Maria Sklodowska-Curie Memorial Cancer Center, Institiute of Oncology, Warsaw, Poland
Principal Investigator: Anna Chaber-Ciopinska, MD Maria Sklodowska-Curie Memorial Cancer Center, Institiute of Oncology, Warsaw, Poland
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Responsible Party: Maria Sklodowska-Curie Institute - Oncology Center
ClinicalTrials.gov Identifier: NCT02435602    
Other Study ID Numbers: 506-1-09-01-14
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Keywords provided by Maria Sklodowska-Curie Institute - Oncology Center:
endoscopy, gastrointestinal
cancer screening
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Esophageal Neoplasms
Squamous Cell Carcinoma of Head and Neck
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases