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

Not Applicable

Completed

• Conditions: Dyspepsia; Barrett's Esophagus
• Interventions: Procedure: Transnasal Endoscopy; Device: Standard upper GI endoscopy; Device: Office-based disposable transnasal endoscopy Endosheath; Procedure: Esophageal biopsies

• Registration Number: NCT02498041
• Lead Sponsor: University of Cambridge

Brief 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).

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2012-07
• Study Completion: 2013-07
• Status Verified: 2015-07
• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-14
• Last Update Submitted: 2015-07-14
• Study First Posted: 2015-07-15
• Last Update Posted: 2015-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

1. Age: > 18 years and <75 years
2. Patients who have given informed consent and who are capable of filling in the questionnaire.
3. Patients requiring endoscopy for dyspepsia or follow-up evaluation and patients with a prior diagnosis of BE (defined as minimum Barrett's length of 2cm - according to M level of Prague C & M classification) with specialized intestinal metaplasia on histological confirmation.

Exclusion Criteria

1. Previous upper GI tract or upper respiratory tract surgery or known upper GI tract abnormality (e.g. pharyngeal pouch).
2. Coagulopathy or on anticoagulants
3. Active or severe cardiopulmonary disease or liver disease
4. Active GI bleeding
5. Patients with alarm symptoms referred to the fast track service and any patient with dysphagia
6. Patients requiring possible endoscopic therapy
7. Patients with high-grade dysplasia or intramucosal carcinoma in BE requiring extensive evaluation and biopsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transnasal Endoscopy	Office-based disposable transnasal endoscopy Endosheath	Unsedated transnasal endoscopy with biopsies
Transnasal Endoscopy	Transnasal Endoscopy	Unsedated transnasal endoscopy with biopsies
Standard Gastroscopy	Esophageal biopsies	Standard endoscopy with biopsies. Patients will decide whether they prefer to have endoscopy with intrevenous sedation or with local anaesthetic only
Transnasal Endoscopy	Esophageal biopsies	Unsedated transnasal endoscopy with biopsies
Standard Gastroscopy	Standard upper GI endoscopy	Standard endoscopy with biopsies. Patients will decide whether they prefer to have endoscopy with intrevenous sedation or with local anaesthetic only

Primary Outcome Measures

Name	Time	Method
Endoscopic Diagnostic Accuracy for Barrett's esophagus	2 weeks	Sensitivity and specificity for detecting BE using ultrathin endoscopy when compared to gold standard conventional endoscopy will be calculated along with 95% Pearson-Clopper confidence intervals.

Secondary Outcome Measures

Name	Time	Method
Optical accuracy	2 weeks	Interobserver agreement for an endoscopic diagnosis of BE by different endoscopic interventions. The optical quality of ultrathin endoscopy will be compared with conventional endoscope by using a 10-cm VAS, where 10 is excellent and 0 is poor.
Histological diagnosis of Barrett's esophagus	2 weeks	Yield of intestinal metaplasia in the biopsies taken at both procedures. The presence of intestinal metaplasia in research biopsies taken using ultrathin endoscopy will be compared with standard endoscopy.
Patient acceptability	12 weeks	The overall acceptability for each procedure will be measured by State-Trait Anxiety inventory, Visual Analogue Scale and SF6 and the choice of procedure in future.
Adverse events	1 week	Any adverse events reported by the patient in the week following the procedure