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New Advances in Gastric Diagnostics: Smaller is Better

In recent years, miniaturization has opened up exciting possibilities in the area of gastric diagnostics. New technology may make routine GI diagnostic procedures as simple as swallowing a vitamin pill-sized encapsulated unit in the not-too-far future, and the present reality is that these units are becoming valuable adjuncts to traditional diagnostics.

Capsule endoscopy (enteroscopy): miniaturized viewing

The Given system, approved by the FDA in August, 2001, allows physiciansfor the first timeto directly view past the first few feet of the small bowel. It can provide valuable diagnostic information, and patients no longer need to undergo traumatic procedures such as push enteroscopy.

The miniaturized endoscopy unit, also called the M2A (for mouth to anus) is swallowed with a drink of water. Patients are unable to feel the unit, and go about normal activities while recording is done. Eight hours later, when the capsule has been propelled through the small intestine system by normal peristalsis, the recorder is removed and the digital data downloaded into a computer for viewing.

The Given capsulized system can provide images for the entire GI tract. It shows promise in diagnosing small bowel diseases including Crohns disease, celiac disease, chronic diarrhea, and pediatric GI disorders. It provides accuracy rates of roughly 55 percent, which is better than current rates for push enteroscopy.

Miniaturized pH Monitoring System

Medtronic has developed the first wireless ambulatory pH monitoring system. This miniaturized system is about the size of a gel capsule, measuring 6X6X26 mm. The Bravo pH monitoring system is tolerated better by patients than traditional transnasal catheters (which are usually only tolerated for about 24 hours). The Bravo can transmit pH levels for up to 48 hours, providing more data for making diagnostic decisions.

The Bravo can provide better and more reliable data for evaluatin g the symptoms of GERD that persist in spite of medication, and in patients considered for anti-reflux surgery, states Mark Traffas, product manager for the Bravo pH system. The longer period of evaluation helps tremendously, since GERD symptoms arent always consistent day-to-day. Bravo also has less reflux-provoking effects than transnasal catheter monitoring.

The miniaturized unit, containing a pH receiver and a small radio transmitter, is attached to the esophageal wall at 5 cm above the lower esophageal sphincter, using a proprietary endoscopic delivery system. Normally patients are unaware of the capsule, although some may feel a mild sensation in the esophagus or chest while eating.

Data on pH levels can be collected without any interference in normal daily activities such as work, exercise, eating, and sleep, and the information is transmitted via telemetry to a pager-sized recording device worn on a belt.

When the data is downloaded via infrared technology from the receiver into a computer, it is analyzed using Medtronics Polygram Net pH software (the same software used to analyze data from their nasal catheter pH monitoring system). The capsule detaches itself from the esophagus, and is passed through the digestive system within seven to 10 days after the initial insertion.

Several studies have shown the advantages of using this miniaturized method of monitoring pH. In a study at Emory University, the Bravo system improved the identification of abnormalities when compared with 24 hour monitoring; it also recorded longer and more frequent reflux episodes. The Bravo was approved by the FDA and has been commercially available since May 2002.

Reimbursement for the Bravo uses the same diagnostic code that was used in the past for pH testing via nasal catheter. Traffas notes that the Bravo pH monitor is gaining increased acceptance. Bravo has grown very rapidly, and there are now 450 centers in the U.S. using it, he stat es.

Miniaturized Ultrasound Probes: EUS allows better visualization

Another area of miniaturized gastric diagnostics is not encapsulated. Instead, Endoscopic Ultrasound (EUS) consists of miniaturized ultrasound probes that can be fit into the tip of endoscopic equipment. EUS allows highly accurate ultrasound imaging of the esophagus and colon for visualizing tumors and determining the depth of invasion, as well as guidance when obtaining biopsies.

Olympus America, Inc. manufactures and distributes the EUS Exera series, high-frequency/high-resolution miniaturized ultrasound probes that are contained within a modified endocope (ultrasonic gastrovideoscope). Newer EUS systems such as the GF-UM160 and the EU-M60 Endoscopic Ultrasound center offer broadband and Dual-plane reconstruction scanning, allowing ultrasound imaging over a wider range that wa impossible with previous systems.

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