March 4, 2005

New procedure seeks to douse heartburn’s flame

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This device is helping reduce the symptoms of gastroesophogeal reflux disease.

New procedure seeks to douse heartburn’s flame

Vanderbilt University Medical Center is offering a new procedure for heartburn sufferers that could reduce the symptoms of gastroesophogeal reflux disease (GERD) in less time than most people take for lunch.

The Medical Center will be participating in an international, multi-center trial of a completely endoscopic corrective treatment for GERD. During the 15- to 20-minute outpatient procedure, a device called the Plicator is used in an attempt to correct the underlying mechanical defect that causes GERD.

“The Plicator procedure is the first endoscopic treatment to replicate what is done during surgery,” said Alfonso Torquati, M.D., assistant professor of Surgery and the principal investigator for this study. “In this study we want to solidify the efficacy of this procedure. We're hopeful that endoscopic treatment will become a viable option for patients.”

More than 15 million Americans suffer from daily heartburn, the most common symptom of GERD. Other symptoms associated with the condition include regurgitation, chest pain, hoarseness, wheezing and chronic cough. GERD can also result in tissue damage from chronic reflux of stomach contents into the esophagus.

Normally, the muscular valve at the end of the esophagus, the lower esophageal sphincter, keeps stomach contents from refluxing up into the esophagus. GERD suffers have a weakened sphincter or one that relaxes too frequently, allowing stomach contents to flow up.

If left untreated, GERD can lead to a variety of esophageal complications, including inflammation, ulceration, or strictures. GERD patients are also at risk to develop a pre-cancerous condition known as Barrett's esophagus.

The Plicator procedure allows physicians to tighten the valve between the esophagus and the stomach, restoring the normal anti-reflux barrier. The Plicator is inserted into the esophagus until it enters the stomach. There, physicians use the device's small arm to retract the gastric wall and make a fold around the sphincter. The device then places one suture to hold the fold together creating a tighter sphincter.

“While medical therapy is very effective for many people, some do not want to be on medication their entire lives, and some cannot afford it,” Torquati said. “Surgery is also effective, but requires hospitalization and a longer recovery time. The Plicator procedure could be a great option, if proven effective in this study.”

“We are continuously searching for less invasive surgical procedures, for options that are less disruptive to our patients' lives,” said William O. Richards, M.D., professor of Surgery, director of Laparoendoscopic Surgery, and co-investigator in this study. “This treatment will have patients home that same day and back to work the next. It could be a big step forward in treating heartburn.”

Approved by the FDA in 2003, the Plicator procedure was shown effective in eliminating medication dependence in 70 percent of treated patients out to one year post-procedure in an earlier trial. The current trial will include 250 patients in both the United States and Europe, of which Vanderbilt will be recruiting 15 to 20 participants.

During the randomized study, participants will get either the Plicator procedure or a “sham” procedure. Participants in the sham procedure will go through all the procedural steps but will not receive a suture.

“We are using the sham procedure to assess the placebo effect,” Torquati said. “But every patient who participates in the trial will have the opportunity to undergo the actual procedure if they choose to do so.”

After three months, study participants will learn if they received the actual procedure or the sham procedure. Those receiving the sham will have the option of undergoing the Plicator treatment at that time.

Participants must be 18 years and older and have been diagnosed with GERD and/or currently taking prescription medication to treat GERD.

For more information call Joan Kaiser, R.N., at 343-5821.