Trials / Completed
CompletedNCT02435602
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 294 (actual)
- Sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | NBI endoscopy | GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy Biopsy at the visually abnormal lesions |
| 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 |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2016-11-01
- Completion
- 2017-01-01
- First posted
- 2015-05-06
- Last updated
- 2018-04-13
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT02435602. Inclusion in this directory is not an endorsement.