Those who suffer from gastroesophogeal reflux disease (GERD) may have new hope thanks to a new international multi-center trial of an endoscopic treatment for the disease.
Image courtesy Vanderbilt Medical Center
by Lisa Peper
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, assistant
professor of surgery and the principal investigator for this study. In
this study we want to solidify the efficacy of this procedure. Were
hopeful that endoscopic treatment will become a viable option for
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 sufferers 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
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 devices 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
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, 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
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 or older and have been diagnosed with
GERD and/or currently taking prescription medication to treat GERD.
For more information, call Joan Kaiser at 343-5821.