Until capsule endoscopy a variety of procedures for diagnosis including endoscopy and barium x-ray were used.   Over 70 % of the international CE users see an important role of Capsule Endoscopy in the detection of Crohn´s disease and suggest to use CE to evaluate Patients with unexplained symptoms, such as chronic diarrhea, which affects about 5 % of the western population. Two recently peer reviewed published trials have demonstrated that in patients with e.g. chronic diarrhea, recurrent pain, possibly weight loss and with negative conventional workup (Gastroscopy, colonoscopy, x-ray), CE can detect a previously undiagnosed Crohn´s disease in up to 70 % of the cases. About 80 % of the patients benefited from the significant reduction of symptoms by the following pharmaceutical treatment. These results are not surprising, as it is known that in 30-40 % of the cases, Crohn´s disease is limited to the small intestine only. As the mid to distal jejunum plus most of the ileum are out of reach of traditional endoscopes and subtle inflammatory mucosal changes are difficult to detect by x-ray, the diagnostic gap and the existing difficulties to diagnose Crohn´s disease in some cases are obvious. The fact that the initial diagnosis in Crohn´s is delayed by over 2 - 6 years, emphazises therefore quite a significant medical need for an improved diagnosis of the small intestine by CE. In the published trials, all Capsules did pass in the patients where an initial diagnosis of Crohn´s disease was made, possibly because significant strictures are likely to be an event at a later, more advanced stage of the disease.

Studies presented at DDW, May 2003, further supporting the beneficial use of Capsule Endoscopy for the diagnosis of Crohn's
disease, include:

* A 30 patient study by Alan Buchman, Frank Miller and Anita Wallin of Northwestern University to determine the accuracy of capsule endoscopy in the diagnosis of Crohn's disease compared to small bowel follow through. The study concluded that capsule endoscopy and small bowel follow through are similarly useful in the diagnosis of Crohn's disease, but clinically significant disease may be missed by small bowel follow through. In addition, capsule endoscopy is less invasive and less time-consuming for the patient than small bowel follow through and avoids radiation. Given that patients with clinically suspected Crohn's disease recurrence may not
have active Crohn's, unnecessary and potentially harmful radiation can be avoided. 

* Dr. Simon K. Lo and a group of physicians from Cedars-SinaiMedical Center in Los Angeles compared the efficacy of capsule
endoscopy versus serology in the evaluation of Crohn's disease.  Physicians categorized 128 patients into three groups. In group A
consisting of 44 patients with known Crohn's disease, capsule endoscopy found small bowel findings in 80% of cases, and 52% had
serologic data available for interpretation. Capsule endoscopy and serology had equal sensitivity in evaluating Crohn's disease. Group
B consisting of 44 patients with suspected Crohn's disease had positive small bowel findings in 52% of cases and 36% had serologic
data available for analysis. Capsule endoscopy and serology had equal sensitivities in detecting IBD, and capsule endoscopy was
superior to Crohn's disease-specific serology (50% vs. 19%). Group C consisting of 40 patients with other indications such as pain,
gastrointestinal bleeding or incidental findings suspicious for IBD using capsule endoscopy. 88% of patients in this group had positive
small bowel findings using capsule endoscopy but only 15% had available serologic data available for analysis. The study concluded
that serology does not predict capsule findings in IBD. Caspule endoscopy and serology have equal sensitivity in evaluating for
Crohn's disease, but capsule endoscopy is superior to Crohn's disease-specific serology in evaluating Crohn's disease. Serology
may be positive in patients with colonic lesions whereas capsule endoscopy is limited in this respect. Capsule endoscopy is positive
in a majority of patients who present with known or suspected Crohn'sdisease. * 

* A team of physicians headed by Winfried Voderholzer are conducting an ongoing study using capsule endoscopy to evaluate
whether small intestinal lesions heal under therapy. This study so far concludes that clinical improvement in Crohn's disease goes along with improvement of sonographic findings rather than with mucosal healing, and that capsule endoscopy is a superior tool for diagnosing mucosal lesions in small intestinal Crohn's disease. 

* A 43 patient study by Dr. Miguel Mascarenhas-Saraiva and Dr. Luis M. Lopes studied the initial diagnosis and follow-up of patients
suffering from Crohn's disease. This study concluded that capsule endoscopy is a safe tool for diagnosing, and evaluating the extent
and activity of Crohn's disease. The study also found that it is useful for a differential diagnosis of indeterminate colitis.  Capsule endoscopy may be the second-line investigation for small bowel Crohn's disease after excluding stenosis by radiological investigation. * 

* A 16 patient study headed by Dr. Peter Bloom of Emory University, compared capsule endoscopy to conventional techniques
including colonoscopy with ileoscopy and small bowel follow through for the evaluation of patients with known or suspected
non-stricturing Crohn's disease. Small intestine findings suggestive of Crohn's disease were detected in 56% of patients using capsule
endoscopy compared to 50% using ileoscopy and 19% of patients by small bowel follow through. Findings suggestive of Crohn's disease proximal to the terminal ileum were detected in 44% of patients using CE compared to no lesions by the combination of ileoscopy and small bowel follow through. Capsule endoscopy provided additional information regarding the extent or absence of small intestinal disease proximal to the terminal ileum. The study concluded that capsule endoscopy appears to be a useful adjunctive tool for the confirmation and evaluation of the extent or exclusion of small intestine disease in patients with known or suspected non-stricturing Crohn's disease. * 

* A team of physicians headed by Dr. Russell Heigh studied 8 patients with suspected Crohn's disease. The study concluded that
capsule endoscopy and CT Enterography are comparable and significantly better than small bowel follow through for the diagnosis of non-obstructing Crohn's Disease. In patients with suspected small bowel Crohn's disease, both capsule endoscopy and CT
Enterography detect additional findings. Capsule endoscopy was found to be more accurate in detecting mucosal pathology, while CT
Enterography may be considered in patients with suspected non-obstructive small bowel Crohn's disease and normal small bowel
follow through, recognizing that even when small bowel follow through is normal a stricture may be identified, resulting in an impacted
capsule. Publishing ID 285* 

* A trial by Furman et al. in 13 patients (aged 9-17 years) concluded that CE detected significant disease in the small bowel in the majority of the patients (12/13) and that it is a safe and effective investigation in paediatric patients over 9 years of age. 7 patients where included in the trial because of suspected small bowelCrohn's disease, 5 because of occult/obscure gastrointestinal
bleeding, 1 because of recurrent abdominal pain.


About DDW
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 17-22, 2003 in Orlando, Florida. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

About Given Imaging

Given Imaging develops, produces and markets the Given(R) Diagnostic System featuring the M2A(R) Capsule Endoscope, the only
non-invasive method for direct visualization of the entire small intestine. The system uses a disposable miniature video camera
contained in a capsule which is ingested by the patient. The M2A capsule passes naturally through the digestive tract, transmitting
high quality color images, without interfering with the patient's normal activities. The system received clearance from the FDA in
August 2001 and received permission to affix the CE mark in May 2001.  Distribution channels for the system have been established in more than 50 countries worldwide. The M2A has been utilized to diagnose a range of diseases of the small intestine including Crohn's Disease,  Celiac disease and other malabsorption disorders, benign and malignant tumors of the small intestine, vascular disorders, medication related small bowel injury, as well as a range of pediatric small bowel disorders. For more information, visit
http://www.givenimaging.com.

21/5/03