More than 15 million Americans suffer from daily heartburn, one of the symptoms of gastroesophageal reflux disease (GERD).
Emory gastrointestinal surgeons are participating in a break-though clinical trial to study the effectiveness of a non-surgical procedure to treat GERD. The procedure is administered through an endoscopically-delivered method called the "Medtronics Gatekeeper Reflux Repair System".
GERD is a term used to describe the variety of symptoms and forms of tissue damage resulting from chronic reflux of stomach contents into the esophagus. One of the most common symptoms of GERD is heartburn, caused when acids reflux, or flow backwards, from the stomach into the esophagus, causing inflammation.
A variety of treatment options for GERD are currently on the market, including medication therapy, surgery and endoluminal (by endoscopy) therapy. All three treatment options are currently available at Emory.
The Gatekeeper study is based on the deployment of several very small packets of an inert hydrogel into the wall of the esophagus at the level of the malfunctioning sphincter (muscle between the esophagus and stomach). The prothesis are advanced along the inside of an endoscope to the level of deployment in the course of an endoscopic examination.
"It is believed that the presence of the hydrogel at the level of the sphincter produces the needed increase in pressure required to abolish GERD," says C. Daniel Smith, MD, Professor of Surgery and Chief of the Division of General and GI Surgery, Emory University School of Medicine.
The treatment for GERD has become a multi-billion dollar business, says Dr. Smith, noting the fierce competition among over-the-counter anti-reflux medications, including antacids, and the numerous surgical options available. In addition to medication therapy, minimally invasive treatments of reflux, such as laparoscopic fundoplication, a procedure made through keyhole incisions, where wrapping the top of the stomach around the sphincter tightens the lower part of the esophagus, have grown in popularity.
"The success of laparoscopic fundoplication has resulted in it becoming one of the more common procedures performed across the nation," Dr. Smith says. "Although widely accepted as an effective and long-lasting option for treating GERD, laparoscopic fundoplication still requires operating through potentially uncomfortable incisions. We are continuously looking for less-invasive treatment options for our patients."
The purpose of the Gatekeeper study is to prove there is an alternative, safe, and equally effective approach to treating GERD that can produce results without any incisions. "The concept of delivering effective, permanent anti-GERD therapy with the use of an endoscope in a patient undergoing only conscious sedation is very appealing," notes Dr. Smith, adding the technology is currently available and has been successfully tested in animal studies.
The total number of patients required in the nation-wide study in order to obtain significant results is 144 patients. There are ten participating institutions, and Emory's contribution will be 13 patients.
For more information on the Gatekeeper study, please call the Emory HealthConnection at 404-778-7777.