A One-Year Follow-up Study of Endoluminal Gastroplication (Endocinch) in GERD Patients Refractory to Proton Pump Inhibitor Therapy

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Abstract
In a subset of patients with gastroesophageal reflux disease (GERD), symptoms persist in spite of proton pump inhibitor (PPI) therapy. Endoscopic gastroplication (EG) was reported to provide a novel therapeutic option in GERD. To evaluate symptomatic and objective outcome of EG in PPI refractory GERD, consecutive GERD patients with persisting reflux symptoms during at least 2 months double dose PPI were recruited for EG (Endocinch). Exclusion criteria were high-grade esophagitis, Barrett’s esophagus, and hiatal hernia >3 cm. Symptoms and PPI use were evaluated before and 1, 3, and 12 months after the EG; 24-hr pH monitoring off PPI was performed before and after 3 and 12 months. All data are given as mean ± SD and were analyzed by Student’s t test. Twenty patients (10 females; mean age, 45 ± 11 years) were recruited. Under conscious sedation with midazolam (6 ± 2 mg) and pethidine (53 ± 5 mg), a mean of 2.0 ± 0.2 sutures was applied during a procedure time of 33 ± 6 min. Throat ache and mild epigastric pain for up to 3 days after the procedure were the only adverse events. At 3 and 12 months symptom score (11.6 ± 6 vs. 6.4 ± 3.7 [P < 0.01] and 7.1 ± 4.5 [P < 0.05]) as well as pH monitoring (% time pH < 4: 17.0 ± 1.1 vs. 8.1 ± 5.7% [P < 0.01] and 9.8 ± 4.1% [P < 0.01]) significantly improved. Ph monitoring was normalized (2-blockers and 1 using cisapride after 3 months. After 12 months only six patients were free of PPI use and pH monitoring was normalized in six patients. We conclude that EG provides short- and medium-term symptomatic and objective relief to a subset of GERD patients refractory to high-dose PPI.