Prospective, Randomized Ex Vivo Trial to Assess the Ideal Stapling Site for Endoscopic Fundoplication with Medigus Ultrasonic Surgical Endostapler

Abstract

Background and Aims. Endoscopic fundoplication is an emerging technique for the treatment of gastroesophageal reflux disease (GERD). The aim of this study is to determine the ideal position of the staples in relation to gastroesophageal junction (GEJ). Methods. Ten endoscopic fundoplication procedures were performed in each group using fresh ex vivo porcine stomachs: Group A: 2 staples each at 3 cm above the GEJ and 180° apart; Group B: 2 staples at 3 cm and 90° apart; Group C: 2 staples at 4 cm and 180° apart; Group D: 3 staples at 3 cm with 90° between each staple (180° total). After the procedure, the stomach was gradually filled with water. Gastric yield pressure (GYP) was determined by detection of reflux of the water in esophagus or by rupture of staples. Results. Mean increase of GYPs (±SD) after the procedure was as follows: Group A: 16.9 ± 8.7; Group B: 8.1 ± 7.9; Group C: 12.2 ± 9.4; Group D: 22.7 ± 13.3. GYP in Group A and Group D was higher than Group B (p = 0.03 and p = 0.01, resp.). Conclusions. We recommend the placement of 3 staples at 3 cm distance from the GEJ, which resulted in the highest increase of GYP.

Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastroesophageal reflux disease: 12-month outcomes

“…MUSE creates a 180°f undoplication by stapling the gastric fundus to the esophagus below the diaphragm under ultrasound guidance. TIF by MUSE was first tested in animal studies and ex vivo models [3,4]. In a multicenter study, the technique was found to be safe and effective up to 4 years [5].…”

Endoscopic interventions in the management of the gastroesophageal reflux: a narrative review

“…An early study using porcine models, found that the endoscopic anterior fundoplication was intact in 12 pigs during post-sacrifice autopsy who underwent the procedure at 2, 4 and 6 weeks prior ( 28 ). An ex-vivo study, performing MUSE fundoplication on porcine esophagus and stomach, demonstrated good reflux control with significantly higher intragastric pressures required to detect stomach contents (methylene blue dyed normal saline), in the esophagus ( 29 ). Compared to the EsophyX device, the literature on MUSE outcomes is still sparse— there are very few small studies that exist to date.…”

Transoral incisionless fundoplication with Medigus ultrasonic surgical endostapler (MUSE) for the treatment of gastro-esophageal reflux disease: outcomes up to 3 years

“…MUSE™ (Medigus, Omer, Israel) creates a 180° fundoplication by stapling the gastric fundus to the esophagus below the diaphragm under ultrasound guidance. TIF by MUSE™ was first tested in animal studies [11] and then in ex vivo models [12]. In three studies the technique was found safe and effective up to four years [5,6,13].…”