Endoscopic, deep mural implantation of enteryx for the treatment of GERD: 6-Month follow-up of a multicenter trial
ABSTRACT 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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ABSTRACT: The term gastroesophageal reflux disease (GERD) describes any symptomatic condition or histopathologic alternation resulting from episodes of gastroesophageal reflux. It usually manifests as heartburn, regurgitation, or dysphagia, and predisposes to development of esophagitis, stricture, Barrett's metaplasia, esophageal adenocarcinoma, and a substantial decreased in the quality of life. Conventional pharmacotherapy (proton pump inhibitor;PPI) is effective, but is associated with a high relapse after discontinuing medication. Laparoscopic Nissen fundoplication is an alternative management regimen for young, healthy patients with severe disease. However, extreme caution is advised in regard to its significant morbidity, high reoperation rate, and an approximate 0.2% mortality rate. Recently, a number of endoscopic or endoluminal approaches have been developed aimed at impro-ving the function of the esophagogastric junction to prevent gastroesophageal reflux and may be ca-tegorized into injection bulking, endoluminal plication, and radiofrequency Stretta procedures. The procedural mechanisms, associated benefits and cost advantages are of interest to researchers. In the present study, we discuss the mechanisms, benefits, and outcomes of each individual option. To date, no standard therapy guideline has been recommended since the appearance of these new endosco-pic procedures. According to limited preliminary data, a new guideline can be established for clinical practice. ( J Intern Med Taiwan 2004; 15: 237-248 )