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

NCT02498041 | Completed DMC

• 1 other identifier: UCambridge
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Barrett's Esophagus; Dyspepsia

Keywords

Ultrathin Nasal Endoscopy; Barrett's Esophagus; Transnasal Endoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Optical accuracy

  2 weeks

• Histological diagnosis of Barrett's esophagus

  2 weeks

• Patient acceptability

  12 weeks

• Adverse events

  1 week

Study Arms (2)

Transnasal Endoscopy

EXPERIMENTAL

Unsedated transnasal endoscopy with biopsies

Procedure: Transnasal Endoscopy; Device: Office-based disposable transnasal endoscopy Endosheath; Procedure: Esophageal biopsies

Standard Gastroscopy

ACTIVE COMPARATOR

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

Device: Standard upper GI endoscopy; Procedure: Esophageal biopsies

Interventions

Transnasal Endoscopy 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.

Also known as: EG530N; Fujinon, Fujifilm, Valhalla, NY

Transnasal Endoscopy

Office-based disposable transnasal endoscopy Endosheath 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.

Also known as: Endosheath; Vision® Sciences, Inc, New York, USA

Transnasal Endoscopy

Standard upper GI endoscopy DEVICE

Upper GI endoscopy with standard gastroscope.

Also known as: Esophago-gastro-duodenoscopy

Standard Gastroscopy

Esophageal biopsies PROCEDURE

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

Also known as: Research biopsies

Standard Gastroscopy; Transnasal Endoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: \> 18 years and \<75 years
• Patients who have given informed consent and who are capable of filling in the questionnaire.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Cambridge: lead
• Medical Research Council: collaborator

MeSH Terms

Conditions

Barrett Esophagus; Dyspepsia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rebecca C Fitzgerald, MD

  University of Cambridge

  PRINCIPAL INVESTIGATOR

• M. Kareem Shariff, MRCP

  University of Cambridge

  PRINCIPAL INVESTIGATOR

• Massimiliano di Pietro, MD

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinician Scientist and Consultant Gastroenterologist

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 15, 2015
• Study Start: April 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: July 15, 2015

Record last verified: 2015-07