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

https://doi.org/10.1016/j.gie.2012.01.029Get rights and content

Background

Unsedated transnasal endoscopy (TNE) may be safer and less expensive than standard endoscopy (SE) for detecting Barrett's esophagus (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

This study enrolled consecutive patients with BE or those referred for diagnostic assessment.

Intervention

All patients underwent 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 were administered.

Main Outcome Measurements

Diagnostic accuracy and tolerability of TNE were compared with those of SE.

Results

Of 95 patients randomized, 82 completed the study. We correctly diagnosed 48 of 49 BE cases by TNE for endoscopic findings of columnar lined esophagus compared with the criterion standard, SE, giving a sensitivity and specificity of 0.98 and 1.00, respectively. The BE median length was 3 cm (interquartile range [IQR] 1-5 cm) with SE and 3 cm (IQR 2-4 cm) with TNE, giving high correlations between the two modalities (R2 = 0.97; P < .001). The sensitivity and specificity for detecting intestinal metaplasia by TNE compared with those by SE was 0.91 and 1.00, respectively. The mean (± standard deviation) post-endoscopy Spielberger State-Trait Anxiety Inventory short-form score for TNE (30.0 ± 1.10 standard error of the mean [SEM]) was lower than that for SE (30.7 ± 1.29 SEM), (P = .054). The visual analogue scale scores were no different (P = .07). The majority of patients (59%) expressed a preference for TNE.

Limitations

This is a small study, with limited generalizability, a high prevalence of patients with BE, differential drop-out between the two procedures, and use of sedation.

Conclusion

TNE is an accurate and well-tolerated method for diagnosing BE compared with SE. TNE warrants further evaluation as a screening tool for BE.

Section snippets

Setting and patients

This study was performed in Cambridge University Hospital National Health Service Foundation Trust within a dedicated research endoscopy unit. All procedures were performed by two experienced endoscopists (E. L. B.-L., M.K.S.) accredited in SE and fully trained in TNE. The study was approved by the Cambridgeshire 2 research ethics committee, Cambridge, United Kingdom, and all patients provided written informed consent.

Two groups of consecutive patients aged >18 years were eligible for this

Enrollment and participants

Between March 2009 and September 2010, 382 patients were eligible for the study and were invited to participate. Of the 382 patients, 95 (25%) consented and were enrolled to undergo SE (n = 51) or TNE (n = 44), of which 13 withdrew (10 after SE and 3 after TNE). Therefore, 82 of 95 (86%) completed the study (Fig. 1). Baseline characteristics of the two groups were similar (Table 1).

Endoscopic and histologic outcomes

As shown in Table 2, 49 participants (52%) had an endoscopic diagnosis of BE on SE, and TNE detected 48 of them.

Discussion

This randomized, crossover, efficacy trial shows that TNE has a sensitivity and specificity of 0.98 and 1.00 for endoscopic detection of BE and 0.91 and 1.00 for detection of columnar lined esophagus with IM, confirmed on biopsy, with almost perfect agreement between the two procedures (K = 0.94; 95% CI, 0.85-1.00). Both procedures also accurately measured length of BE (R2 = 0.97; P < .001). Despite the smaller biopsy size with TNE, the pick-up rate for IM was identical to that of SE. Patients

Acknowledgments

We thank the participants of the study and Imotech Medical Ltd for loan of their endoscopes. We are grateful to the staff of Addenbrookes Centre for Clinical Investigation, Addenbrookes Treatment Centre Endoscopy and tissue bank, including Bev Spencer and Roberto Cayado-Lopez. We would like to thank Sarah Vowler, from the Cambridge Research Institute, for her initial advice on sample size. We are very grateful to Mimi McCord and the McCord Foundation for funding.

References (49)

  • K. Saeian et al.

    Unsedated transnasal endoscopy accurately detects Barrett's metaplasia and dysplasia

    Gastrointest Endosc

    (2002)
  • A. Catanzaro et al.

    Prospective evaluation of 4-mm diameter endoscopes for esophagoscopy in sedated and unsedated patients

    Gastrointest Endosc

    (2003)
  • P.J. Nietert et al.

    Cost-effectiveness of screening a population with chronic gastroesophageal reflux

    Gastrointest Endosc

    (2003)
  • P. Sharma et al.

    A critical review of the diagnosis and management of Barrett's esophagus: the AGA Chicago Workshop

    Gastroenterology

    (2004)
  • P. Sharma et al.

    The development and validation of an endoscopic grading system for Barrett's esophagus: the Prague C & M criteria

    Gastroenterology

    (2006)
  • D.S. Levine et al.

    An endoscopic biopsy protocol can differentiate high-grade dysplasia from early adenocarcinoma in Barrett's esophagus

    Gastroenterology

    (1993)
  • J.A. Knottnerus et al.

    Assessment of the accuracy of diagnostic tests: the cross-sectional study

    J Clin Epidemiol

    (2003)
  • R. Dekel et al.

    Progression or regression of Barrett's esophagus—Is it all in the eye of the beholder?

    Am J Gastroenterol

    (2003)
  • D. Sorbi et al.

    Unsedated small-caliber esophagogastroduodenoscopy (EGD) versus conventional EGD: a comparative study

    Gastroenterology

    (1999)
  • M.S. Mokhashi et al.

    A prospective, blinded study of diagnostic esophagoscopy with a superthin, stand-alone, battery-powered esophagoscope

    Am J Gastroenterol

    (2003)
  • A. Catanzaro et al.

    Accuracy of a narrow-diameter battery-powered endoscope in sedated and unsedated patients

    Gastrointest Endosc

    (2002)
  • R.T. Garcia et al.

    Unsedated ultrathin EGD is well accepted when compared with conventional sedated EGD: a multicenter randomized trial

    Gastroenterology

    (2003)
  • J. Dumortier et al.

    Prospective evaluation of transnasal esophagogastroduodenoscopy: feasibility and study on performance and tolerance

    Gastrointest Endosc

    (1999)
  • H.C. Wolfsen et al.

    Prospective, controlled tandem endoscopy study of narrow band imaging for dysplasia detection in Barrett's Esophagus

    Gastroenterology

    (2008)
  • Cited by (86)

    • The Horizon of Screening for Barrett's Esophagus and Esophageal Cancer

      2023, Techniques and Innovations in Gastrointestinal Endoscopy
    • Noninvasive tests for eosinophilic esophagitis: Ready for use?

      2022, Annals of Allergy, Asthma and Immunology
    • Barrett's Esophagus: Diagnosis, Management, and Key Updates

      2021, Gastroenterology Clinics of North America
    • Progress in Screening for Barrett's Esophagus: Beyond Standard Upper Endoscopy

      2021, Gastrointestinal Endoscopy Clinics of North America
      Citation Excerpt :

      Transnasal endoscopy (TNE) uses ultrathin nasoendoscope for imaging and sampling the esophagus and can be done under local anesthetic. In a randomized crossover study of cases and controls comparing TNE versus standard endoscopy, TNE diagnosed BE with sensitivity and specificity of 98% and 100%, respectively and was associated with less anxiety.47 A multicenter, prospective, cross-sectional study demonstrated that TNE was well tolerated by patients, had shorter procedural time, and was safe.48

    View all citing articles on Scopus

    DISCLOSURE: This study was supported by funding from the McCord Foundation (to R.F.), Cambridge Experimental Cancer Medicine Centre, NIHR Cambridge Biomedical Research Centre, and a core grant from the Medical Research Council. All funding was awarded to R.F. No other financial relationships relevant to this publication were disclosed.

    If you would like to chat with an author of this article, you may contact Dr Fitzgerald at [email protected].

    Drs Shariff and Bird-Lieberman contributed equally to this article.

    View full text