NCT02498041

The Efficacy and Patient Tolerance of Ultrathin Nasal Endoscopy to Detect Barrett's Oesophagus

Study to Compare the Efficacy and Patient Tolerance of Ultrathin Nasal Endoscopy to Detect Barrett's Esophagus Compared With Conventional Endoscopy to Inform a Future Multicentre Screening Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: University of Cambridge · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Barrett's Esophagus
• Dyspepsia

Interventions

Type	Name	Description
PROCEDURE	Transnasal Endoscopy	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.
DEVICE	Office-based disposable transnasal endoscopy Endosheath	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.
DEVICE	Standard upper GI endoscopy	Upper GI endoscopy with standard gastroscope.
PROCEDURE	Esophageal biopsies	2 research biopsies taken if endoscopic evidence of columnar-lined esophagus

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-07-01
• Completion: 2013-07-01
• First posted: 2015-07-15
• Last updated: 2015-07-15