By Tammy Gay

"Patients often do not want to take medication daily and for many, even new minimally invasive surgical techniques for fundoplication are not acceptable. Newer endoscopy treatments introduced over the last two years have not found widespread acceptance because they are either technically very complex, or because they cause permanent damage to the esophagus."

-- Nicholas J. Nickl, M.D., professor of internal medicine in the division of gastroenterology, UK College of Medicine

Aug. 9, 2002 (Lexington, Ky.) -- A new investigational endoscopy procedure performed by a University of Kentucky physician for the first time in the state earlier this week could be the future answer to gastroesophageal reflux disease (GERD).

Nicholas J. Nickl, M.D., professor of internal medicine in the division of gastroenterology, UK College of Medicine, used an endoscope to implant expandable hydrogel prostheses into the wall of a patient's esophagus in a short outpatient procedure at the UK Endoscopy Center. The prostheses are intended to provide a barrier to acid reflux.
UK is only the third site in the United States to participate in the clinical research trial, with fewer than a dozen sites worldwide.

Frank Cienniwa, a 32-year-old Lexington man, underwent the investigational treatment Wednesday.
The Gatekeeper Reflux Repair System clinical trial, sponsored by Medtronic, Inc., is testing the safety and effectiveness of the new device. Nickl is planning to implant 10 or more participants with this investigational device over the next year.
"Patients suffering from acid reflux have options of either expensive daily medication therapy to prevent the formation of stomach acid or a surgical anti-reflux procedure called fundoplication," Nickl said.

"Patients often do not want to take medication daily and for many, even new minimally invasive surgical techniques for fundoplication are not acceptable. Newer endoscopy treatments introduced over the last two years have not found widespread acceptance because they are either technically very complex, or because they cause permanent damage to the esophagus," Nickl added.

The new investigational procedure is much simpler to perform and appears to cause no permanent damage to the esophagus. Unlike the current approved procedures, it also is easily reversed in an outpatient endoscopy procedure, Nickl said.

The investigational prostheses are made of the same material as contact lenses and are the size of small pencil lead when inserted into the esophagus wall, Nickl said. The prostheses then swell to act like soft pillows, acting as barriers to the reflux of acid. However, the prostheses are soft enough not to block food from entering the stomach.

Patients commonly complain of serious heartburn before being diagnosed with GERD, which results when a muscle in the esophagus, the lower esophageal sphincter (LES), becomes ineffective. This abnormality allows stomach content, including digestive acid, to move upstream into the esophagus, causing pain and injury to the area.

More than 60 million American adults experience reflux and heartburn at least once a month, and approximately 21 million adults are estimated to have GERD. People who are not treated for the disease continue to have symptoms and may experience complications such as ulcers or in rare cases cancer.

To participate in the clinical research trial at UK, a person must have acid reflux disease, and its symptoms must be largely controlled with medication - with no previous surgery to correct the problem.
Theoretical risks include obstruction to swallowed food, bleeding and infection.

For more information about the clinical research trial, call (859) 257-3401.