Efficacy of endoscopic anterior fundoplication with a novel ultrasonic surgical endostapler for gastroesophageal reflux disease: Six-month results from a multicenter prospective trial

Abstract

Background and Objectives: Endoscopic therapy is an option for the treatment of refractory gastroesophageal reflux disease (GERD). We aimed to evaluate the efficacy and safety of transoral incisionless fundoplication with the Medigus ultrasonic surgical endostapler (MUSE™) for refractory GERD. Materials and Methods: Patients with 2 years of documented GERD symptoms and at least 6 months of proton-pump inhibitors (PPIs) therapy were enrolled in four medical centers from March 2017 to March 2019. The GERD health-related quality of life (HRQL) score, GERD questionnaire score, total acid exposure on esophageal pH probe monitoring, the gastroesophageal flap valve (GEFV), esophageal manometry, and PPIs dosage were compared between the pre- and post-MUSE procedure. All of the side effects were recorded. Results: A reduction of at least 50% in the GERD-HRQL score was observed in 77.8% (42/54) patients. Most patients 74.1% (40/54) discontinued PPIs and 11.1% (6/54) reported a ≥50% dose reduction. The percentage of patients who had normalized acid exposure time after the procedure was 46.9% (23/49). The existence of hiatal hernia at baseline was negatively correlated with the curative effect. Mild pain was common and resolved within 48 h postprocedure. Serious complications were pneumoperitoneum (one case), mediastinal emphysema combined with pleural effusion (two cases). Conclusions: Endoscopic anterior fundoplication with MUSE was an effective treatment for refractory GERD, but still needs refinement and improvement in safety aspect. Esophageal hiatal hernia may affect the efficacy of MUSE. ( www.chictr.org.cn, ChiCTR2000034350 )

Role of endoscopy in gastroesophageal reflux disease

“…40,52 In two prospective single-arm studies, this technique demonstrated therapeutic efficacy (improved GERD-HRQL and discontinuation of daily PPI) with a relatively safe profile at 6 months. 52,53 In another study comprising 34 patients with GERD, of the 20 subjects who underwent the MUSE procedure and completed follow-up, 70% experienced significant improvement (50% reduction in GERD-related symptom scores) in GERD-HRQL, 65% in heartburn symptoms, 75% in regurgitation symptoms, and 65% stopped PPI therapy at 12 months post-procedure. 54…”

Comprehensive review of materials, applications, and future innovations in biodegradable esophageal stents

“…Current treatments for ES encompass various modalities, including drug therapy, surgical interventions, endoscopic esophageal dilation, and endoscopic stent placement, among others ( Sehgal and Sami, 2021 ). Pharmacological treatment entails the administration of proton pump inhibitors (PPI) for managing GERD ( Peng et al, 2023 ). Additionally, endoscopy-guided infusion of adrenocorticotropic and cytotoxic drugs into the stenosis site serves to inhibit fibrosis and scar formation in damaged tissue, thereby alleviating scarring-induced permanent ES ( Zein et al, 1995 ).…”