PillCam ESO Comparable to Upper Endoscopy in Detecting Esophageal Varices
and Po
DGNews
PillCam ESO Comparable to Upper Endoscopy in Detecting Esophageal Varices
and Portal Hypertension in Cirrhotic Patients
Patients prefer PillCam ESO as screening method for varices
YOQNEAM, ISRAEL -- February 8, 2006 -- Given Imaging Ltd. today announced
that two independent studies concluded that PillCam(TM) ESO is an accurate,
noninvasive alternative to upper endoscopy, the current "gold standard" for
evaluating patients and the most commonly performed procedure in detecting
esophageal varices in cirrhotic patients.
Both prospective studies were published in the January issue of Endoscopy,
the official publication of the European Society of Gastrointestinal
Endoscopy.
Chronic liver disease affects 360 out of every 100,000 people in the U.S.,
results in 300,000 hospitalizations annually and costs over $2 billion a
year according to National Institutes of Health. The two most common
diseases are cirrhosis and fibrosis of the liver. In cirrhosis of the liver,
scar tissue replaces normal, healthy tissue, blocking the flow of blood
through the organ and preventing it from working as it should. Portal
hypertension and esophageal varices are two of the main complications of the
disease.
Gavriel D. Meron, president and CEO of Given Imaging said, "Both American
and European societies recommend that cirrhotic patients be screened to
detect esophageal varices and portal hypertension. We believe this data will
prove interesting to insurers and lead them to reimburse for PillCam ESO as
a screening tool for these indications."
The first study was led by researchers from the Oregon Health and Science
University in Portland, the Department of Internal Medicine of the
University of Milan, Italy, and the Department of Gastroenterology at Rambam
Medical Center in Haifa, Israel. The multi-center, multi-national pilot
study of 32 cirrhotic patients assessed PillCam ESO's ability to detect
esophageal varices when compared to upper endoscopy in cirrhotic patients.
The study also evaluated patients' tolerance and preference for each
technique. It was concluded that PillCam ESO detected varices in 23 patients
and signs of portal hypertension in 19 patients, matching the upper
endoscopy findings. The patients studied also felt that PillCam ESO was more
convenient and less uncomfortable than the standard endoscopy examination.
Glenn Eisen, MD, lead author and Associate Professor of Medicine and
Clinical Director of Gastroenterology, Oregon Health and Science University,
said, "The results confirm that the capsule endoscopy technique is an
accurate, safe, well-tolerated, rapid alternative screening method to detect
esophageal varices without the need for conscious sedation and the costs
associated with it."
A second study led by Professor Thierry Ponchon, of Edouard Herriot Hospital
in Lyon, France assessed 21 cirrhotic patients to determine the accuracy of
PillCam ESO and how well patients tolerate the procedure compared to upper
endoscopy for portal hypertension screening. The researchers concluded that
there was complete diagnostic agreement on the presence or absence of
esophageal varices in 85% patients.
The study showed that the sensitivity of PillCam ESO for all large varices
which require treatment was 100%. The study also reported that all 20
patients who swallowed the capsule preferred PillCam ESO.
SOURCE: Given Imaging Ltd.
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