Background: Endoscopic, endoluminal therapy might be an alternative treatment option in light of the costs of proton pump inhibitor therapy and possible complications after laparoscopic surgery. The aim of the current study was to assess the efficacy and the safety of a new endoluminal suture device (ESD) in pig models and humans. Secondly, 3 and 6 months' follow-ups were performed, and possible complications and their management were evaluated.
Methods: In the preclinical phase of the study, suturing procedures were practiced and evaluated in 8 pig models (Erlanger Endo Trainer). In the clinical phase, 20 patients with mild esophagitis, small or no hiatal hernia, and signs of abnormal acid exposure (pH measurements) were enrolled. Therapeutic endoscopy (propofol sedation) was performed with the flexible suture and the Ti-Knot devices, which were introduced over an external accessory channel, fixed on the endoscope. One to 3 sutures were applied per patient at the gastroesophageal junction. A 3 months' follow-up included upper endoscopy, manometry, 24-hour pH study, and clinical questionnaires.
Results: Visibility with the new device was good, and, in all cases, sutures could be applied with only minor complications. In the animal model, the stitches reached the muscularis propria. However, the 3-month follow-up showed that only 12% of all plications persisted over this short period in humans. In addition, the clinical response was poor (no significant changes after the procedure: pH study, proton pump inhibitor intake, lower-esophageal sphincter pressure on manometry). In two patients, acute bleeding occurred, which was successfully controlled with endoscopic therapy. However, these patients were observed overnight in the hospital without further complications. The study was interrupted after 3 months because of the results of the interim analysis.
Conclusions: The new endoscopic suturing device allows a feasible and safe technique for application of endoscopic sutures. The procedure could be performed on an outpatient basis by using sedation with propofol. However, the clinical outcome was very limited because of the high number of lost or failed plications. Thus, the ESD currently cannot be recommended in the treatment of patients with GERD.