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

Introduction: Percutaneous endoscopic gastrostomy (PEG) is a well-established procedure for providing long-term enteral nutrition. Until recently, the only established introducer PEG involved the use of gastropexy sutures. In June 2021, an introducer PEG without gastropexy received regulatory approval. The aim of this study was to evaluate and compare gastropexy-assisted introducer PEG (gPEG) versus gastropexy-free introducer PEG (dPEG). Patients and Methods: In this prospective study patients were randomized in a 1:1 ratio to gPEG or dPEG. The primary endpoint was PEG placement time (local skin incision to successful intragastric tube positioning). Secondary endpoints were total procedure time, technical feasibility, adverse events, and functional tube patency over a 30-day follow-up period. Results: 37 patients were enrolled: 22 patients (59%) gPEG group vs 15 patients (41%) dPEG group. PEG placement time was comparable (260 ± 109 seconds vs. 265 ± 145 seconds; p > 0.05). 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). Minor post-procedural complications occurred in 2 patients (9%) vs. in 6 patients (40%) (p<0.01). No major complications were observed. During the 30-day follow-up, tube dislocation was documented in 2 patients (9%) vs. 5 patients (33%) (p=0.0953). 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.