Endoluminal Treatment of GERD -- Role in Contemporary Clinical Practice

John K. DiBaise, MD, FACG; Dmitry Oleynikov, MD


August 04, 2004

In This Article


Gastroesophageal reflux disease (GERD) is an extremely common condition that encompasses a diverse spectrum of clinical presentations and has a substantial impact on patient quality of life and utilization of healthcare resources.[1,2,3,4] Despite the proven safety and effectiveness of proton-pump inhibitors (PPIs) and laparoscopic fundoplication in the treatment of GERD, the perceived need for an alternative has been made clear both by patients who suffer from GERD and the physicians who treat them. In view of the limitations and costs associated with current antisecretory medications and antireflux surgery,[5,6] there has been considerable interest in the endoluminal treatment of GERD. This is evidenced by the many recent reports using a variety of minimally invasive techniques performed on an outpatient basis involving moderate sedation and analgesia.

The concept of endoluminal treatment for GERD is appealing because it has the potential to shift the focus of treatment from symptom control to disease control, while also offering the possibility of decreased morbidity compared with surgery and decreased need for compliance with antisecretory medications (yet not preventing the use of either of these options in the future, if desired). To date, there have been 3 main endoluminal approaches used to treat GERD: suturing, radiofrequency (RF) energy, and injection/implantation techniques ( Table 1 ). The US Food and Drug Administration (FDA) currently has cleared or approved 4 endoluminal therapies for use in patients with GERD: the EndoCinch (cleared March 2000), Stretta (cleared April 2000), Enteryx (approved April 2003), and Plicator (cleared April 2003) systems. Although much information concerning many of these devices has been reported in abstract form, this article focuses solely on published articles reporting on the safety and efficacy of these devices.

Virtually all of the published reports on these FDA-approved devices have used similar uncontrolled study designs and similar eligibility criteria consisting of nonobese patients dependent upon daily antisecretory medication (PPIs most commonly) and without severe esophagitis, moderate-to-large hiatal hernia, Barrett's esophagus, very-low lower esophageal sphincter (LES) pressure, or ineffective esophageal motility. Study outcome measures have also been similar, including changes in antisecretory medication use, individual and composite GERD symptom scores, and quality of life. In addition, most studies have evaluated the effects of these therapies on endoscopic esophagitis, LES pressure, and esophageal acid exposure. Treatment responders have been variably defined.