Given Imaging's PillCam SB provides gold standard accuracy in diagnosing small bowel tumours

Orlando 02 November 2004Results from a study of patients with small bowel tumours have been presented in a poster session at the American College of Gastroenterology meeting. In addition to confirming PillCam SB's ability to diagnosis small bowel tumours that go undetected by other imaging approaches, the data also showed that the majority or 65 percent of small bowel tumours discovered were malignant. The study was led by Dr. Jamie S. Barkin and Gregory D. Schwartz of the Division of Gastroenterology, Mt. Sinai Medical Center, University of Miami School of Medicine.

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"Capsule endoscopy has enabled us to make considerable progress in the detection and diagnosis of small bowel tumours", stated Dr. Barkin. "The patients in this study all had undergone a variety of other diagnostic assessments that failed to identify their tumours. Capsule endoscopy provides a gold standard of accuracy that is essential to beginning an appropriate treatment regimen for these tumours. This is especially important for appropriate treatment of malignant tumours of the small bowel, which comprised 65 percent of the tumours identified with capsule endoscopy in this study."

This study examined 72 patients from the Given Imaging clinical database in whom PillCam SB diagnosed 73 small bowel tumours, 1 cecal tumour and 1 gastric tumour that were subsequently confirmed by histologic methods. These 72 patients, who presented with obscure GI bleeding, abdominal pain, anemia or polyposis, had previously undergone 334 negative procedures or an average of 4,6 per patient, that failed to identify these tumours. Procedures included 115 colonoscopies, 111 upper endoscopies, 32 small bowel follow through procedures, 24 enteroscopies, 17 CT scans, 16 enteroclysis procedures, 6 nuclear bleeding cans, 5 angiographies, 5 plain abdominal x-rays, 1 abdominal ultrasound, 1 Meckel's scan and 1 laparoscopy.

The data presented at the meeting confirm the results of previous studies from Sweden, France, German and the United States conducted in a total of 1029 patients using PillCam SB. Results from the four studies recently were presented at both Digestive Disease Week (DDW) 2004 as well as the United European Gastroenterology Week (UEGW) 2004, and demonstrated that at least 50 percent of small bowel tumours are malignant.

Importantly, these studies indicate that small bowel tumours occurred in 6 to 9 percent of patients who underwent capsule endoscopy in order to diagnosis the cause of gastro-intestinal symptoms. Previous studies using other diagnostic methods have reported a small bowel tumour rate of only 2 percent. These studies underscore the superiority of PillCam SB in the detection of small bowel tumours.

Early detection of small bowel tumors is a key factor in initiating appropriate therapy and achieving a positive treatment outcome. Thus, the use of PillCam SB in diagnosing the cause of gastro-intestinal symptoms has the potential to improve disease management for patients with small bowel tumours.

Given Imaging is redefining gastro-intestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastro-intestinal disorders. The company is developing a complete line of PillCam video capsules for detecting disorders throughout the gastro-intestinal tract. The company's technology platform is the Given Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient.

The PillCam SB video capsule is the only naturally ingested method for direct visualization of the entire small intestine. It is currently marketed in the United States and in more than 60 other countries and has benefited more than 145.000 patients worldwide. The PillCam ESO video capsule, which provides visual examination of the esophagus, has been cleared for marketing by the FDA and a higher frame rate version will be commercialized pending FDA clearance.

Additional capsules for visualization of the stomach and colon are under development. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel. It has direct sales and marketing operations in the United States, Germany and France, and local offices in Tokyo, Madrid and Sydney. More news on Given Imaging's PillCam is available in this VMW issue's article Given Imaging's PillCam ESO as accurate as endoscopy in visualizing abnormalities of the esophagus.


Leslie Versweyveld

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