The Efficacy and Patient Tolerance of Ultrathin Nasal Endoscopy to Detect Barrett's Oesophagus
Condition: Barrett's Esophagus; Dyspepsia
MeSH terms: Barrett Esophagus; Dyspepsia
Study type: Interventional

Summary: 
      This study evaluates the diagnostic accuracy, safety and acceptability of transnasal
      endoscopy (TNE) for a diagnosis of Barrett's esophagus (BE). This is a cross-over randomised
      trial, whereby patients receive two endoscopic procedures 2-4 weeks apart and will be
      randomised to receive either TNE or standard endoscopy followed by the other procedure.
    

Detailed description: 
      Background: The incidence of esophageal adenocarcinoma (EAC) has drammatically increased in
      the Western World in the last 30 years. Furthermore it often presents in the late stages and
      the prognosis remains poor with an overall 5-year survival of 10-15%. Early detection is
      possible since most cases of EAC develop from a precursor condition, Barrett's esophagus
      (BE), via a metaplasia-dysplasia-adenocarcinoma sequence. BE can be diagnosed with an upper
      GI endoscopy.

      Un-sedated trans-nasal endoscopy (TNE) may be safer and less expensive than standard
      endoscopy (SE) for detecting BE. Emerging technologies require robust evaluation before
      routine use.

      Objective: To evaluate the sensitivity, specificity, and acceptability of TNE in diagnosing
      BE compared with those of SE.

      Design:Prospective, randomized, crossover study

      Setting:Single, tertiary-care referral center.

      Patients: patients with BE or those referred for diagnostic assessment will be enrolled
      consecutively .

      Intervention: All patients will undergo TNE followed by SE or the reverse. Spielberger
      State-Trait Anxiety Inventory, short-form questionnaires, a visual analogue scale, and a
      single question addressing preference for endoscopy type will be administered.

      Main Outcome Measurements: Diagnostic accuracy for BE and tolerability of TNE and SE.

      The primary aim of this study is to evaluate the sensitivity and specificity of ultrathin
      endoscopy in diagnosing BE (using standardised endoscopic and histopathological criteria)
      compared with the gold standard white light conventional endoscopy.

      The secondary aims include to assess the acceptability, optical quality and safety of the two
      interventions.

      The study will consist of two phases. In a first large phase 80% of the target (90 patients)
      we will evaluate conventional TNE (Fujinon). In a second phase the remaining of the patients
      (25) will be evaluated with a disposable office-based system (Endosheath).
    

Intervention name(s): Transnasal Endoscopy; Office-based disposable transnasal endoscopy Endosheath; Standard upper GI endoscopy; Esophageal biopsies
Intervention type(s): Procedure; Device; Device; Procedure
Intervention description(s): Experimental procedure with transnasal endoscopy for the first 80% of the patients (n=90). The examination is limited to the esophagus and the proximal stomach.; Experimental procedure with portable, disposable transnasal endoscopy for the last 20% of patients only (n=25). The examination is limited to the esophagus and the proximal stomach.; Upper GI endoscopy with standard gastroscope.; 2 research biopsies taken if endoscopic evidence of columnar-lined esophagus
Other intervention name(s): EG530N; Fujinon, Fujifilm, Valhalla, NY; Endosheath; Vision® Sciences, Inc, New York, USA; Esophago-gastro-duodenoscopy; Research biopsies
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Ultrathin Nasal Endoscopy; Barrett's Esophagus; Transnasal Endoscopy