Background: The incidence of oesophageal adenocarcinoma is increasing rapidly with a 5-year survival of less that 20%. The majority of patients with its precursor lesions, Barrett’s oesophagus, remain undiagnosed. Population screening for Barrett’s oesophagus by endoscopy is impractical and expensive. The aim of this study was to develop a non-endoscopic screening test for BE suitable for primary care.

Methods: A non-endoscopic sampling device, a capsule-sponge attached to a string, was used to obtain oesophageal specimen from 43 BE patients and 53 healthy volunteers. Liquid based cytology was used to create a cell-monolayer, which was stained for minichromosome maintenance protein 2 (Mcm2 expressed at the luminal surface of BE epithelium). Samples were considered positive if columnar cells had nuclear staining. Three individuals unaware of the clinical diagnosis assessed the slides. To determine the acceptability of the test, the patients used a linear rating tool (10 enjoyable, 5 neither unpleasant nor pleasant, 0 very unpleasant).

Results: The acceptability of the capsule was rated as 4.0 (2.0-9.0) and there were no complications. 91/96 (94.8%) patients had adequate specimens for analysis. 27/41 (66%) BE specimens were positive compared with 17/52 (33%) specimens from healthy volunteers giving a sensitivity and specificity of 67%. The negative and positive predictive values of the test were 73% and 61% respectively. Positive Barrett’s had a statistically longer segment than negative patients (5.7 ± 0.6 and 3.2 ± 0.5respectively; p=0.01). If a segment of ≥3 cm is considered necessary for a diagnosis of BE the sensitivity and specificity were 76.0% and 62.7% respectively.

Conclusions: The capsule sponge is acceptable to patients, applicable to primary care and provides a good cell yield. Further refinements in technique to increase the sensitivity and specificity of this test may be necessary before population based studies can be performed. However, this is a very promising non-endoscopic test for BE and warrants further investigation.

98th AACR Annual Meeting-- Apr 14-18, 2007; Los Angeles, CA