Preclinical trial of a modified gastroscope that performs a true anterior fundoplication for the endoluminal treatment of gastroesophageal reflux disease

Abstract

BACKGROUND: Laparoscopic fundoplication provides good reflux control, but side-effects due to the surgical procedure are known. Differentendoluminal techniques have been introduced, but all with disappointing results.

OBJECTIVE: Evaluation of the feasibility and safety of a new device, which enables a totally endoluminal anterior fundoplication for the treatment ofgastroesophageal reflux disease (GERD).

MATERIAL: The device is a modified video gastroscope, which incorporates a surgical stapler (using standard 4.8 B-shaped surgical staples) and an ultrasonic sight. The cartridge is mounted on the shaft and the anvil is at the tip. This enables accurate stapling of the fundus to the esophagus, using the ultrasonic sight to guide distance and alignment of the anvil and the cartridge.

METHOD: Sixteen female swine of mixed breed were used in the study; 12 underwent the endoscopic procedure, and 4 were used a controls to monitor weight gain. The 12 study animals were sacrificed at 2, 4, and 8 weeks (4 pigs each time) and visually inspected for complications, healing, and fundoplication. The study was sponsored by MediGus Ltd. and monitored for compliance with good laboratory practice (GLP) regulations by an external company (Econ Inc.), which is GLP certified by the German Federal Government. It was conducted at the animal testing facility of the Charité Virchow Clinic in Berlin.

RESULTS: The procedure went smoothly in all pigs; median procedure time was 12 min (range 9-35 min). At sacrifice, the stapled area had healed well, all animals had a satisfactory 180° anterolateral fundoplication, and there were no procedure-related complications.

CONCLUSIONS: Creating a satisfactory anterior fundoplication with the new device is feasible, easy, and safe. Proof of efficacy must await clinical trials, which are underway.