In this population-based, prospective, randomized pilot study, we have demonstrated the feasibility of population screening for BE. Unsedated techniques (uTNE and VCE) appeared to have greater numerical acceptability in the population than sEGD, although this difference was not statistically significant. These alternative screening methods were well tolerated in this pilot study.
The goals of this study were to demonstrate feasibility of population-based screening for BE and to obtain preliminary estimates of participation rates for noninvasive screening techniques (uTNE, VCE) in comparison with sEGD so that sample size for a larger study could be obtained. We chose this study design as opposed to one in which all 3 techniques would be offered to every patient (with the patient choosing which would be most acceptable) so that we could obtain estimates of participation for each of the 3 techniques (and compare the rates with those for sEGD), in addition to testing their tolerability, safety, and yield, which would be difficult to obtain from an alternative study design. We used a previously created population-based cohort (with data on age, sex, and reflux symptoms) to draw samples for this study because this allowed us to draw samples that were balanced in terms of demographic characteristics and reflux symptoms, in addition to enabling us to offer screening to patients with and without reflux symptoms.
Unsedated techniques could be more cost-effective as screening tools, given the direct and indirect costs of sEGD. A modeling study that assessed the costs of screening patients with uTNE found this approach to be cost-effective.29
However, that study assumed a 95% acceptability rate, which may be an overestimate and underscores the need for collecting real data before valid conclusions can be drawn.
Although initial studies suggested that esophageal capsule endoscopy can identify BE in patients accurately,19
subsequent studies have shown lower accuracy30
and the lack of cost-effectiveness,31
resulting in a consensus that it cannot be recommended for BE screening at this time. In 1 of the 17 patients completing VCE in the current study, the procedure was nondiagnostic because of nonvisualization of the gastroesophageal junction; 3 patients required follow-up endoscopy to reassess the gastroesophageal junction because of potential abnormalities seen on the capsule study. Results of all 3 endoscopic examinations were unremarkable. This further highlights the limitations of VCE in terms of accuracy at this time.
A recent study from Europe32
analyzed the ability of a capsule sponge device to provide cytologic specimens to detect biomarkers for BE. The sensitivity of this technique was 78%, leading to a false-negative rate of 22%, which could lead to a substantial number of false-negatives in a large population. Furthermore, confirmation would be required in a population with low BE prevalence and an endoscopic test would be required after a positive test, making downstream costs a concern. However, nonendoscopic techniques, if accurate, offer the potential of widespread applicability, allowing risk stratification of the population risk for EAC.33
One of the limitations of the current study is the small sample size, potentially leading to type II error. This study was performed to demonstrate the feasibility of conducting a randomized population-based study, determine initial safety, and obtain preliminary estimates of participation rates to determine the sample size for a definitive larger-scale study. Although response bias is a possibility because the cohort consisted of responders to previous questionnaires, this is unlikely because of the lack of difference between responders and nonresponders that is now well documented in this population.34