Swalloable cell-collection device can detect Barrett's esophagus in GERD patients: Lancet
UK: A non-endoscopic test may improve the detection of Barrett's esophagus in patients with gastro-oesophageal reflux, a recent study in The Lancet journal has revealed. Further, the cytosponge-trefoil factor 3 (TFF3) testing with Swalloable cell-collection device could also diagnose early cancer and dysplasia at an earlier and potentially curable stage.
Barrett's esophagus is a condition characterized by damage to the lower portion of the esophagus (the tube that connects the mouth and stomach). It is usually caused by repeated exposure to stomach acid. It is estimated that about 3–6% of individuals with gastro-oesophageal reflux-predominant symptoms could develop Barrett's esophagus -- precursor lesion to oesophageal adenocarcinoma. However, only 20% of patients with Barrett's esophagus are diagnosed. The late diagnosis of the oesophageal adenocarcinoma lowers the survival chances in such patients.
Knowing that the treatment of dysplastic Barrett's esophagus can prevent progression to adenocarcinoma, an optimal diagnostic strategy becomes necessary. The aim of this study by Rebecca C Fitzgerald, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK, and colleagues was to investigate whether cytosponge-TFF3 testing in patients on gastro-oesophageal reflux mediations could increase the detection of Barrett's esophagus compared with standard management.
This trial was performed in 109 socio-demographically diverse general practice clinics in England. It included patients who were aged 50 years and older and taking acid-suppressants for symptoms of gastro-oesophageal reflux for more than 6 months and had not undergone an endoscopy procedure within the past 5 years. Randomization was done both at the general practice clinic level (cluster randomization) and at the individual patient level, and the results for each type of randomization were analyzed separately before being combined. For cluster randomization, clinics were randomly assigned (1:1) by the trial statistician using a computer-generated randomization sequence; for individual patient-level randomization, patients were randomly assigned (1:1) by the general practice clinics using a centrally prepared computer-generated randomization sequence.
After randomization patients received either standard management of gastro-oesophageal reflux (usual care group), in which participants only received an endoscopy if required by their general practitioner or usual care plus an offer of the Cytosponge-TFF3 procedure, with a subsequent endoscopy if the procedure identified TFF3-positive cells (intervention group).
The primary outcome was the diagnosis of Barrett's esophagus at 12 months after enrolment, expressed as a rate per 1000 person-years, in all participants in the intervention group (regardless of whether they had accepted the offer of the Cytosponge-TFF3 procedure) compared with all participants in the usual care group. Analyses were intention-to-treat.
13 514 of 13 657 eligible patients were randomly assigned (per practice or at the individual patient level) to the usual care group (n=6531) or the intervention group (n=6983). On further scrutiny after randomization, 2% of 6983 participants in the intervention group and 2% of the 6531 participants in the usual care group did not meet all eligibility criteria or withdrew from the study. Of the remaining 6834 participants in the intervention group, 39% expressed an interest in undergoing the Cytosponge-TFF3 procedure. Of these, 65% met all of the eligibility criteria on telephone screening and underwent the procedure. Most of these participants (1654 [95%]; median age 69 years) swallowed the Cytosponge successfully and produced a sample.
Key findings of the study include:
- 231 (3%) of 6834 participants had a positive Cytosponge-TFF3 result and were referred for an endoscopy.
- Patients who declined the offer of the Cytosponge-TFF3 procedure and all participants in the usual care group only had an endoscopy if deemed necessary by their general practitioner.
- During an average of 12 months of follow-up, 140 (2%) of 6834 participants in the intervention group and 13 (<1%) of 6388 participants in the usual care group were diagnosed with Barrett's esophagus.
- Nine (<1%) of 6834 participants were diagnosed with dysplastic Barrett's esophagus (n=4) or stage I oesophagogastric cancer (n=5) in the intervention group, whereas no participants were diagnosed with dysplastic Barrett's esophagus or stage I gastro-oesophageal junction cancer in the usual care group.
- Among 1654 participants in the intervention group who swallowed the Cytosponge device successfully, 221 (13%) underwent endoscopy after testing positive for TFF3 and 131 (8%, corresponding to 59% of those having an endoscopy) were diagnosed with Barrett's esophagus or cancer.
- One patient had a detachment of the Cytosponge from the thread requiring endoscopic removal, and the most common side-effect was a sore throat in 63 (4%) of 1654 participants.
"The offer of Cytosponge-TFF3 testing results in gastro-oesophageal reflux patients improved the detection of Barrett's esophagus. Cytosponge-TFF3 testing could also lead to the diagnosis of treatable dysplasia and early cancer. This strategy will lead to additional endoscopies with some false-positive results," concluded the authors.
The study, "Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial," is published in the journal Lancet.