The need is well recognized for additional data on endoluminal therapies for gastroesophageal reflux disease.
Dr Schumacher and colleagues designed a prospective multicenter clinical trial to assess safety and effectiveness of Enteryx, a nonresorbable copolymer implanted into the lower esophagus.
The researchers assessed whether Enteryx reduced the usage of proton pump inhibitors, improved reflux symptoms and quality of life.
The research team performed enteryx implantation under fluoroscopic visualization without general anesthesia in 93 patients with symptomatic gastroesophageal reflux disease responsive to and relapsing upon cessation of proton pump inhibitor therapy.
The team collected subjective and objective data up to 12 months postprocedure.
|Reflux-related heartburn, regurgitation symptoms, physical and mental quality of life scores improved|
| Journal of Clinical Gastroenterology |
The investigators’ criterion for treatment success was reduction in proton pump inhibitors dosage of equal to or more than 50%.
At 12 months, treatment success was attained in 86% of 74 evaluable patients and elimination of proton pump inhibitor therapy in 65%.
The researchers showed that the treatment success rate by intent-to-treat analysis was 69%.
The team also noted that reflux-related heartburn, regurgitation symptoms, and physical and mental quality of life scores improved.
In addition, the investigators observed that the most frequent complications were chest pain (77%), dysphagia/odynophagia (27%), and sensation of fever (26%).
Dr Schumacher concluded, “Enteryx implantation provides an effective and safe alternative for management of gastroesophageal reflux, reducing medication dependency and symptoms and enhancing quality of life.”