Percutaneous ultrasound gastrostomy (PUG): first prospective clinical trial

Abstract

To report the results of the first-in-human trial evaluating the safety and efficacy of the percutaneous ultrasound gastrostomy (PUG) technique. A prospective, industry-sponsored single-arm clinical trial of PUG insertion was performed in 25 adult patients under investigational device exemption (mean age 64\u2009±\u200915 years, 92% men, 80% inpatients, mean BMI 24.5\u2009±\u20092.7 kg/m2). A propensity score-matched retrospective cohort of 25 patients who received percutaneous radiologic gastrostomy (PRG) was generated as an institutional control (mean age 66\u2009±\u200914 years, 92% men, 80% inpatients, mean BMI 24.0\u2009±\u20092.7 kg/m2). Primary outcomes included successful insertion and 30-day procedure-related adverse events (AE’s). Secondary outcomes included procedural duration, sedation requirements, and hospital length of stay. All PUG procedures were successful, including 3/25 [12%] performed bedside within the ICU. There was no significant difference between PUG and PRG in rates of mild AE’s (3/25 [12%] for PUG and 7/25 [28%] for PRG, p\u2009=\u20090.16) or moderate AE’s (1/25 [4%] for PUG and 0/25 for PRG, p\u2009=\u20090.31). There were no severe AE’s or 30-day procedure-related mortality in either group. Procedural room time was longer for PUG (56.5\u2009±\u200914.1 min) than PRG (39.3\u2009±\u200915.0 min, p\u2009<\u20090.001). PUG procedure time was significantly shorter after a procedural enhancement, the incorporation of a Gauss meter to facilitate successful magnetic gastropexy. Length of stay for outpatients did not significantly differ (2.4\u2009±\u20090.5 days for PUG and 2.6\u2009±\u20091.0 days for PRG, p\u2009=\u20090.70). PUG appears effective with a safety profile similar to PRG. Bedside point-of-care gastrostomy tube insertion using the PUG technique shows promise. Trial Registration Number: ClinicalTrials.gov ID NCT03575754.