Gastropexy-Assisted vs. Gastropexy-Free Introducer Percutaneous Endoscopic Gastrostomy: A Prospective Randomized Trial.

Introduction Percutaneous endoscopic gastrostomy (PEG) is a well-established and low-complication procedure for providing long-term enteral nutrition. In cases of oropharyngeal or esophageal stenosis, PEG can be safely performed using an introducer PEG. Until recently, the only established introducer PEG involved the use of gastropexy sutures. In June 2021, an alternative technique received regulatory approval. This method employs introducer PEG without prior gastropexy, securing the stomach to the abdominal wall using a tire-shaped balloon (FLOCARE DirectPEG). To date, no studies have directly compared these two techniques. The aim of this study was to prospectively evaluate and compare the procedural efficiency and clinical outcomes of gastropexy-assisted introducer PEG (gPEG) versus gastropexy-free introducer PEG (dPEG). Patients and Methods This prospective, randomized trial included patients with a confirmed indication for enteral nutrition via PEG. Eligible patients were randomized in a 1:1 ratio to receive either gPEG or dPEG. The primary endpoint was PEG placement time, measured from local skin incision to successful intragastric positioning of the tube. Secondary endpoints included total procedure time, technical feasibility, adverse events, and functional tube patency over a 30-day follow-up period. Results A total of 37 patients were enrolled, with 22 patients (59%) assigned to the gPEG group and 15 patients (41%) to the dPEG group. PEG placement time was comparable between the groups (260 ± 109 s vs. 265 ± 145 s; p  > 0.05). However, the procedural performance of gPEG was rated significantly better than that of the dPEG system (mean score 1.5 vs. 3.0; p < 0.01). In two patients (13%) in the dPEG group, the procedure had to be discontinued due to technical issues with tube deployment. Minor postprocedural complications occurred in 2 patients (9%) in the gPEG vs. in 6 patients (40%) in the dPEG ( p < 0.01). No major complications were observed. During the 30-day follow-up, tube dislocation was documented in 2 patients (9%) in the gPEG group compared to 5 patients (33%) in the dPEG group ( p = 0.0953). Tube patency was maintained in 100% of cases. Due to emerging clinically relevant differences in procedural feasibility and complication rates, the study was terminated prematurely. Conclusion In this study, the established gPEG demonstrated superior ease of use and a significantly more favorable safety profile. Based on these findings, the conventional gastropexy-assisted introducer PEG remains the preferred approach.