Three Studies Confirm PillCam ESO’s Promise as Screening Tool for Esophageal Varices in Cirrhotics

SAN DIEGO -- Given Imaging Ltd. announced that data from three new studies underscore the value of PillCam® ESO capsule endoscopy as a valuable, patient-friendly tool for screening cirrhotic patients for esophageal varices. One study will publish in the June 2008 issue of Hepatology, and two other abstracts were presented during the annual Digestive Disease Week® (DDW) 2008 conference in San Diego from May 17-22.

The current "gold standard" screening method, esophagogastroduodenoscopy (EGD), is uncomfortable, invasive, costly and requires sedation, which may limit adherence to screening programs, according to the study in Hepatology. Fifty percent of cirrhosis patients develop varices within 10 years.² Twenty percent of patients who develop large varices die within six weeks.³

Led by Roberto de Franchis, MD -- head of the gastroenterology and GI endoscopy unit, Ospedale Policlinico, Mangiagalli and Regina Elena Foundation, Milano, at the department of medical sciences, University of Milan -- the Hepatology study assessed the diagnostic performance of PillCam ESO using EGD as the gold standard. While agreement between the two methods was 86 percent, the study did not meet its primary endpoint of demonstrating equivalence to EGD within 10 percent. There was significant agreement (91 percent) between the two methods with respect to specificity in determining those patients who had large varices and those with small varices, although sensitivity was lower at 78 percent. Overall, patients significantly preferred PillCam ESO to EGD. The results of the study also confirmed the utility of a standard scoring system to grade images of varices captured with PillCam ESO, and the authors did note that in some instances, grading by the capsule was thought to be more precise than EGD.

"Since patients rate capsule endoscopy as more comfortable and convenient, broader use of this tool may lead to better adherence to guidelines and ultimately improve the outcomes if more patients undergo screening," said de Franchis.

A second study presented as a poster at DDW 2008, "Screening for Esophageal Varices in End-Stage Liver Disease: Utility of Esophageal Capsule Endoscopy," (Abstract #M1370) and led by Ayodele T Osowo, MD, and colleagues, found that PillCam Esophageal capsule endoscopy identified varices in 38 percent (83) of the 217 patients in a prospective study. PillCam also helped physicians diagnose gastric varices in 1.3 percent (3) of the patients and portal hypertensive gastropathy in 11 percent (24).

"Our study shows that capsule endoscopy is a valuable screening tool for esophageal varices in cirrhotic patients," said Osowo, fellow at the Mayo Clinic in Scottsdale, Ariz. "Other findings in this study suggest it may also be useful for diagnosis of other co-existent esophageal and gastric pathologies. Relative ease of ingestion and convenience may make this a more attractive alternative for patients." Osowo presented the poster on Monday, May 19, at DDW.

A third study presented at the DDW podium, "Randomized Controlled Trial of Esophageal Capsule Endoscopy Versus Standard Endoscopy for Screening in Patients Pre-Liver Transplantation. Assessment of Inter-Observer Variability and Patient Preferences," (Abstract #472), presented by lead author Lauren B. Gerson, MD, MSc, from Stanford Unversity School of Medicine, compared PillCam ESO’s diagnostic results to EGD in 24 patients awaiting liver transplants. An expert hepatologist performed the EGDs. Two blinded independent faculty experts interpreted ECE images.

EGD detected varices in 12 (50 percent) of the patients and PillCam ESO found varices in 11 (46 percent) of them. Varices were graded as F1=small straight varices; F2=enlarged tortuous varices < 1/3 of the lumen; and F3=large coil-shaped varices ≥ 1/3 lumen. Both methods detected significant (grade F2-F3) varices in eight patients. The EGD and PillCam ESO readers demonstrated 100 percent agreement for small varices (Grades F0/F1) and agreed 88 percent of the time for the higher grade (F2/F3) varices. A majority of the patients (61 percent) preferred PillCam endoscopy over EGD (9 percent), and patients reported less discomfort (p=0.03), greater satisfaction (p=0.03) and less fatigue (p<0.001) associated with the ECE examination compared to standard EGD.

"In patients awaiting a liver transplantation who are undergoing screening for the presence of esophageal varices, PillCam capsule endoscopy was sensitive, specific, and preferred by patients compared to standard sedated endoscopy," said Gerson, associate professor of medicine at Stanford University. "There was also good agreement between capsule endoscopy experts regarding the grading of varices. If the goal of endoscopic screening is to identify patients with large varices who can undergo subsequent endoscopic or medical therapy, our study demonstrated that all of the patients at high risk of bleeding from esophageal varices would have been identified accurately by esophageal capsule endoscopy. By using PillCam ESO to screen for varices, the majority of patients with advanced liver disease can be spared the discomfort and time associated with standard upper endoscopy, and potentially the risk of exacerbation of underlying encephalopathy associated with the usage of conscious sedation."

"We are encouraged by the growing body of data supporting PillCam ESO," said Homi Shamir, chief executive officer, Given Imaging. "Since our inception, Given Imaging has sought to redefine gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. Studies such as these confirm the value of PillCam products."

About Esophageal Varices
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 the National Institutes of Health. The two most common diseases leading to varices 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 (enlarged veins) are two of the main complications of the disease.

In advanced cases of liver cirrhosis, scar tissue spreads and restricts the blood from flowing through the liver. This can cause the veins in the esophagus to enlarge. It’s vital to monitor for the appearance of these enlarged veins, or varices, and to keep track of their size. Roughly one-fourth of these varices eventually start to bleed, and 10 percent to 20 percent of patients die within six weeks of the bleeding episode.

About PillCam ESO
Cleared by the U.S. Food and Drug Administration in November 2004 to visualize the esophagus in adult patients in a patient-friendly way, the PillCam ESO can be used to aid in the detection of disorders such as Barrett's esophagus, a potential precursor for esophageal cancer and esophageal varices, which if left untreated can result in fatal bleeding. PillCam ESO contains imaging devices and light sources at both ends of the capsule that capture up to 14 images per second, a total of 2,600 color images, as it passes down the esophagus in a twenty-minute procedure.

References
1. Mergener, Literature Review and Recommendations For Clinical Application of Small Bowel Capsule Endoscopy Based on a Panel of International Experts: Endoscopy, Vol.39, October 2007
2. D’Amico G, Pasta L, Madonia S, et al. The incidence of esophageal varices in cirrhosis. Gastroenterology 2001;120:A2.
3. D’Amico G, de Franchis R, and the Cooperative Study Group. Upper digestive bleeding in cirrhosis: post-therapeutic outcomes and prognostic indicators. Hepatology 2003;38:599-612

Source: Given Imaging