- New swallowable
balloon device detects pre-cancerous Barrett's esophagus in a fast,
minimally invasive and cost effective way.
esophagus (BE) is the precursor lesion of esophageal adenocarcinoma, which
if detected earlier can prevent the lethal cancer.
- The five minute
outpatient test which is more than 90% sensitive for detecting BE could be
a better alternative than the traditionally used endoscopy.
New swallowable test enables to
detect Barrett's esophagus in a fast, minimally invasive and cost effective
manner. The test was developed by research teams at Case Western Reserve
University School of Medicine and University Hospitals Cleveland Medical
Center. This test could replace the traditionally used endoscopy, which is an
expensive and invasive test that requires sedation, making it unsuitable for widespread
screening. The swallowable balloon device with over 90% sensitivity in
detecting Barrett's esophagus could prevent a large number of deaths from
esophageal adenocarcinoma. The development of the test and the results of a
clinical trial using the test are published in Science Translational
Barrett's Esophagus and its Diagnosis
Barrett's esophagus (BE) is the
precursor lesion of a highly lethal cancer called esophageal adenocarcinoma
can be prevented if patients are diagnosed at the precursor stage of Barrett's
esophagus. However, traditional BE detection methods include endoscopy, which
is an expensive and invasive screening test that requires sedation and hence is
not preferred for routine screening.
"Our goal is early
detection," said Dr. Amitabh Chak, Professor of Medicine and head of the
NIH-Case Barrett's Esophagus Translational Research Network "BETRNet"
program "Symptoms of Barrett's
, such as heartburn, can also be commonly seen in
individuals who have acid reflux disease without BE. These symptoms can easily
be treated by over the counter medications so people often don't get tested for
BE, particularly by an invasive test such as endoscopy. As a result, when
individuals develop EAC, 95 percent of the time the presence of the prior
Barrett's esophagus was undetected and unknown. We wanted an easier, less
costly test that could provide a practical way for screening and early
detection of individuals with BE, who can then be followed closely to prevent
development of EAC."
The Swallowable Test
new test is an easy, five minute outpatient procedure which is more than 90
percent sensitive for detecting individuals with BE. Patients are simply
required to swallow a pill sized balloon that swabs the esophagus. The pill
once retrieved through the mouth, is tested for DNA mutations
that the team has discovered are
diagnostic of BE.
‘Balloon sampling and DNA assay for the methylated VIM and CCNA1 biomarkers allowed the creation of a simple, non-invasive, safe, and accurate BE screening.’
Paralelly, Helen Moinova, PhD,
the first author of the study led another study to identify DNA changes
diagnostic of Barrett's. Using genome-wide sequencing approaches, Dr. Moinova
identified two genes, VIM and CCNA1, that get chemically modified by DNA
methylation in BE. The DNA assay showed 90.3% sensitivity for detecting
individuals with BE and 91.7% specificity for correctly identifying individuals
who were normal.
"Having two accurate
biomarkers increases confidence in our ability to correctly diagnose Barrett's
esophagus," said Dr. Moinova. "Taken together, our findings show that
non-endoscopic balloon sampling paired with molecular tests for the methylated
VIM and CCNA1 biomarkers is effective in addressing the need for simple,
non-invasive, safe, and accurate Barrett's esophagus screening."
The Clinical Trial
clinical trial included 86 individuals who were tested for BE using the
swallowable esophageal balloon device.
participants were asked to swallow the device, which was attached to a thin
silicone catheter. Once the pill was delivered to the stomach, the small
balloon was inflated by injecting air through the catheter. The inflated
balloon was maneuvered to swab the lower esophagus near the stomach, the place
where BE begins, and obtain a sample of the lining cells. After collecting the
sample, the balloon was deflated and inverted back into the capsule, to protect
the sample. The capsule was then retrieved through the mouth
and DNA was extracted from the balloon to perform Dr. Moinova's DNA assay.
The procedure was well tolerated
by the patients. 82 percent reported little to no anxiety, pain, or choking. 93
percent stated they would repeat the procedure again. 95 percent said they
would recommend the test to others.
The positive results from the
clinical trial show that the new screening method can significantly change the
method and increase the efficacy of BE screening.
- H.R. Moinova el al., "Identifying DNA methylation biomarkers for non-endoscopic detection of Barrett's esophagus," Science Translational Medicine (2018).DOI: 10.1126/scitranslmed.aao5848