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

NCT ID: NCT02498041

Last Updated: 2015-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2013-07-31

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).

Conditions

Barrett's Esophagus; Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Transnasal Endoscopy

Unsedated transnasal endoscopy with biopsies

Group Type: EXPERIMENTAL

Transnasal Endoscopy

Intervention Type: PROCEDURE

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.

Office-based disposable transnasal endoscopy Endosheath

Intervention Type: DEVICE

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.

Esophageal biopsies

Intervention Type: PROCEDURE

2 research biopsies taken if endoscopic evidence of columnar-lined esophagus

Standard Gastroscopy

Standard endoscopy with biopsies. Patients will decide whether they prefer to have endoscopy with intrevenous sedation or with local anaesthetic only

Group Type: ACTIVE_COMPARATOR

Standard upper GI endoscopy

Intervention Type: DEVICE

Upper GI endoscopy with standard gastroscope.

Esophageal biopsies

Intervention Type: PROCEDURE

2 research biopsies taken if endoscopic evidence of columnar-lined esophagus

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Standard upper GI endoscopy

Upper GI endoscopy with standard gastroscope.

Intervention Type: DEVICE

Esophageal biopsies

2 research biopsies taken if endoscopic evidence of columnar-lined esophagus

Intervention Type: PROCEDURE

Other Intervention Names

EG530N; Fujinon, Fujifilm, Valhalla, NY; Endosheath; Vision® Sciences, Inc, New York, USA; Esophago-gastro-duodenoscopy; Research biopsies

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Council

OTHER_GOV

Sponsor Role: collaborator

University of Cambridge

OTHER

Sponsor Role: lead

Responsible Party

Massimiliano di Pietro, MD

Senior Clinician Scientist and Consultant Gastroenterologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca C Fitzgerald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

M. Kareem Shariff, MRCP

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Massimiliano di Pietro, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Other Identifiers

UCambridge

Identifier Type: -

Identifier Source: org_study_id