Clinical feasibility of a new full-thickness endoscopic plication device (GERDx™) for patients with GERD: results of a prospective trial

Abstract

BackgroundPrevious studies suggest clinical effectiveness of endoscopic full-thickness plication in selected patients with gastroesophageal reflux disease (GERD). The aim of this study was to assess the clinical safety and efficiency of the GERDx™ device by evaluating clinical parameters, reflux symptom scores, and quality of life (QoL).MethodsProspective one-arm trial evaluating the outcome of forty patients with GERD subjected to endoscopic plication with the GERDx™ device. We included patients with at least one typical reflux symptom despite treatment with a PPI for > 6 months, pathologic esophageal acid exposure, hiatal hernia of size < 2 cm, and endoscopic Hill grade II–III. Evaluation of Gastrointestinal Quality of Life Index (GIQLI), symptom scores, esophageal manometry, and impedance-pH-monitoring were performed at baseline and at 3 months after surgery. (Trial Registration: ClinicalTrials.gov NCT 01798212.)ResultsThere were no intraoperative complications. Four out of forty patients experienced postoperative complications requiring intervention. Seven of forty patients were subjected to laparoscopic fundoplication 3 months after endoscopic plication due to persistent symptoms and were lost to further follow-up. Thirty out of forty patients were available at 3-month follow-up. There was an improvement of the GIQLI score, from a mean of 92.45 ± 18.47 to 112.03 ± 13.11 (p < 0.001). The general reflux-specific score increased from a mean of 49.84 ± 24.83 to 23.93 ± 15.63 (p < 0.001), and the DeMeester score from a mean of 46.48 ± 30.83 to 20.03 ± 23.62 (p < 0.001). There was no significant change in manometric data after intervention. Three of thirty patients continued daily antireflux medication.ConclusionsEndoscopic plication with the GERDx™ device reduced distal acid exposure of the esophagus, reflux-related symptoms, and improved GIQLI scores with minimal side effects in a selected cohort of patients and may be a safe alternative in the treatment of GERD.

Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial

“…A previous prospective single-arm study had reported positive results on the efficacy of the GERD-X device for the treatment of patients with GERD on PPIs and refractory GERD. 12 However, randomised trials and long-term follow-up data are needed to determine the efficacy and safety of the device in treating patients with GERD. The objective of this single-centre, randomised, sham-control trial was to determine the efficacy and safety of EFTP (GERD-X) in patients with PPI-dependent GERD, compared with the sham procedure, in improving the health-related quality of life (GERD-HRQL), GERD symptoms and oesophageal acid exposure.…”

“…The arms were closed, and as per the study protocol 2 pre-tied transmural pledget sutures were deployed to ensure full-thickness plication and tight closure of gastro-oesophageal junction around the device. 12 The EFTP system and the ultraslim endoscope were then straightened, removed and the gastroscope was reintroduced to evaluate the post plication gastro-oesophageal junction. No retreatments were allowed.…”

Aktueller Stand bei den endoskopischen Therapieverfahren der GERD (Endoplikation): GERDX, MUSE, EsophyX

“…Im Laufe der letzten 15-20 Jahre wurden zusätzlich endoskopische Verfahren entwickelt, die zu einem kompetenten Ventilmechanismus führen sollten. [23].…”

Unusual cause of anemia postendoscopic full‐thickness plication in a 28‐year‐old Asian male

“…His Hb normalized and was clinically better. GERDx™ has been used to treat reflux‐related symptoms with promising results in GERD . To the best of our knowledge, this is the first unusual complication of the GERDx procedure.…”