Abstract
Introduction: Laparoscopic Nissen Fundoplication (LNF) is considered the gold standard of surgical treatment of GERD. An emerging endoscopic technology, the EsophyX (EsophyXTM, EndoGastric Solutions Inc.) Endo Luminal Fundoplication (ELF), aims at reproducing the effect of the fundoplication by creating an intragastric valve with fasteners applied at the Gastro-Esophageal Junction (GEJ). Both techniques increase resting pressure and length of the Lower Esophageal Sphincter (LES). This study aims to compare the short termmanometric profile of ELF with 8 fasteners to LNF. Materials and Methods: Twelve 40-kg pigs were randomized to either ELF or LNF. Under general aesthesia, the LES resting pressure (mm Hg) and length (cm), were manometrically assessed before (T0) , immediately after (T2) and 1 and 4 weeks after each procedure (ELF and LNF). In the ELF group manometry was carried out midway through as well, after the placement of 4 corner fasteners (T1). Solid state manometric catheters with 4 sensors were used. Endoscopies were performed to assess the anatomy and location of the GEJ before and after fundoplication. Results: The 2 groups were comparable according to preoperative manometry and endoscopy. Median operative time was 45 minutes (range 40-50) for ELF and 30 min (range 25-35) for LNF. LES mean increase in resting pressure (9.22 for ELF vs 10.6 mmHg for LNF) and length (2 cm for both ELF and LNF; range1-3cm) improved similarly and significantly (p<0.05) in both groups with no significant difference in the measured parameters between the two techniques at any of the given time points. In the ELF group the main increase in LES resting pressure was achieved at T1 (p 0.02) with no significant raise between T1 and T2. The postoperative manometric profile in both groups was unchanged and similar 1 and 4 weeks postoperatively. Notably, the significant increase in LES resting pressure was preserved (p<0.05). The endoscopic aspect of ELF and LNF was comparable 1 and 4 weeks postoperatively. Conclusions: This study demonstrated an immediate and short term physiological effect of ELF comparable to that achieved with the gold standard LNF, providing a similar increase in LES resting pressure and length. The position of the fasteners is an important factor of efficacy of the ELF.
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