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

Dyspepsia Clinical Trial

— NOSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498041
• Other study ID #: UCambridge
• Status: Completed
• Phase: N/A
• First received: July 7, 2015
• Last updated: July 14, 2015
• Start date: April 2009
• Est. completion date: July 2013

Study information

• Verified date: July 2015
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Research Councils UKUnited Kingdom: National Institute for Health ResearchUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: July 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Dyspepsia

Intervention

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.
• Standard upper GI endoscopy
Upper GI endoscopy with standard gastroscope.

Procedure:
• Esophageal biopsies
2 research biopsies taken if endoscopic evidence of columnar-lined esophagus

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Cambridge	Medical Research Council

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic Diagnostic Accuracy for Barrett's esophagus	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.	2 weeks	No
Secondary	Optical accuracy	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.	2 weeks	No
Secondary	Histological diagnosis of Barrett's esophagus	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.	2 weeks	No
Secondary	Patient acceptability	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.	12 weeks	No
Secondary	Adverse events	Any adverse events reported by the patient in the week following the procedure	1 week	Yes

External Links

•   Randomized crossover study comparing efficacy of transnasal endoscopy with that of standard endoscopy to detect Barrett's esophagus