Endoscopic, Deep Mural Implantation of Enteryx for the Treatment of GERD: 6-Month Follow-up of a Multicenter Trial

Eastern Virginia Medical School, Norfolk, Virginia, United States
The American Journal of Gastroenterology (Impact Factor: 10.76). 02/2003; 98(2):250-8. DOI: 10.1111/j.1572-0241.2003.07291.x
Source: PubMed


This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD.
Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score < or = 11 on PPI and > or = 20 off PPI, and 24-hour PH probe with > or = 5% total time at PH < or = 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3-4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period.
At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p < 0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p < 0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation.
The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.

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    ABSTRACT: astroesophageal reflux disease (GERD) is very common. Approximately 20% of adult Amer- icans have heartburn at least once a week. The goals of therapy for GERD are to eliminate symptoms, to heal injured esophageal mucosa, and to prevent reflux complications.1 Treatment options for GERD have been highlighted by potent acid suppression with proton pump inhibitors (PPIs) and minimally inva- sive antireflux surgery. Recently, endoscopic therapies for GERD have been introduced. Treatment selection should be individualized and dependent upon underly- ing pathophysiology, anatomy, and clinical presentation coupled with the expected success or limitations of each therapeutic option. This article reviews the pathophysiol- ogy of GERD and the spectrum of clinical presentation, and discusses how these factors affect treatment consider- ations. Medical, surgical, and emerging endoscopic treat- ment options are discussed.

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