Endoscopic anti-reflux valve for post-esophagectomy reflux: an animal study

Abstract

Gastric reflux into the remnant esophagus after subtotal or partial esophagectomy is associated with impairment in patient quality of life. We evaluated the feasibility, safety, and potential effectiveness of a novel procedure using a new endoscopic suturing device to create an anti-reflux valve (funnel) in pigs after esophagectomy with gastric tube reconstruction. The endoscopic procedure was performed in four pigs using a semi-full-thickness endoscopic suturing system (OverStitch; Apollo Endosurgery, Austin, Texas, USA). The operating time, funnel height, ratio of the height of the funnel to the diameter of the gastric tube, and adverse events associated with the procedure were evaluated. The "reflux angle" was measured morphologically and functionally during a reflux induction test, using contrast medium or artificial gastric fluid, by tilting the operating table gradually from a head up to a head down position. Reflux angles before and after funnel creation were compared. The procedure was successful in all four animals. The median operating time was 43 minutes, and the median funnel height was 17 mm (56.7 % of gastric tube diameter). There were no adverse events associated with the procedure. The reflux angle was lower after the procedure compared with before in both morphological and functional assessments in all four cases. Endoscopic anti-reflux funnel creation using OverStitch was feasible, safe, and potentially effective.

Endoscopic augmentation of gastroesophageal junction using a full-thickness endoscopic suturing device

“…The endoscopic antireflux funnel creation was successful in all 4 animals, and the median funnel height was 17 mm. There were no adverse events reported 16 . Since the pigs were euthanized at the end of the study, long-term durability could not be evaluated and further studies are needed to prove efficacy and safety in human patients.…”

“…There has been 1 prior study on the use of a full-thickness endoscopic suturing device in GERD. Yanagimoto et al 16 evaluated the safety, feasibility, and potential effectiveness of endoscopic antireflux funnel creation using a full-thickness endoscopic suturing device in 4 pigs after esophagectomy. The endoscopic antireflux funnel creation was successful in all 4 animals, and the median funnel height was 17 mm.…”

Endoscopic approaches to gastroesophageal reflux disease

“…It has been used in a variety of settings including primary endoscopic obesity surgery, closure of perforations, leaks or fistulae, and for fixation of covered metal stents. The feasibility and safety in GERD treatment were first demonstrated in an animal study [44]. Subsequently, Han et al [45] performed the technique in 10 patients and found significantly improved GERD-HRQL but low rate of PPI cessation at only 20% at short-term follow-up (median 5 months).…”

Successful Endoscopic Treatment of Post-esophagectomy Refractory Reflux Using OverStitch: The First Clinical Case

“…The technical details of our procedure were described elsewhere. 8 OverStitch (Apollo Endosurgery) Suturing System was mounted onto the tip of a double-channel flexible endoscope (GIF-T240; Olympus Medical Systems, Tokyo, Japan). Under general anesthesia with endotracheal intubation, a short endoscopic overtube (6C23A; Top Corp., Tokyo, Japan) was placed in the remnant esophagus to facilitate both atraumatic passage of the endoscope with suturing devices and to prevent aspiration pneumonia.…”

“…6,7 We previously reported its use in endoscopic endoluminal antireflux valve (funnel) creation procedure in animal models and indicated its feasibility, safety, and potential effectiveness for GTER. 8 In this short communication, we describe our “first in human” experience with endoscopic antireflux funnel procedure using OverStitch.…”