Abstract
Graphical abstarctPurposeTo report the results of the first-in-human trial evaluating the safety and efficacy of the percutaneous ultrasound gastrostomy (PUG) technique.MethodsA prospective, industry-sponsored single-arm clinical trial of PUG insertion was performed in 25 adult patients under investigational device exemption (mean age 64 ± 15 years, 92% men, 80% inpatients, mean BMI 24.5 ± 2.7 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 ± 14 years, 92% men, 80% inpatients, mean BMI 24.0 ± 2.7 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.ResultsAll 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 = 0.16) or moderate AE’s (1/25 [4%] for PUG and 0/25 for PRG, p = 0.31). There were no severe AE’s or 30-day procedure-related mortality in either group. Procedural room time was longer for PUG (56.5 ± 14.1 min) than PRG (39.3 ± 15.0 min, p < 0.001). 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 ± 0.5 days for PUG and 2.6 ± 1.0 days for PRG, p = 0.70).ConclusionPUG 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.Graphical abstract
Highlights
Percutaneous gastrostomy tube insertion involves the placement of a feeding tube through the abdominal wall directly into the stomach for enteral nutrition in individuals unable to tolerate per-oral intake
Mean procedural room time was longer for Percutaneous ultrasound gastrostomy (PUG) insertion
Mean hospital length of stay for outpatients admitted to hospital for gastrostomy tube insertion did not differ between the PUG group (2.4 ± 0.5 days, n = 5) and percutaneous radiologic gastrostomy (PRG) controls (2.6 ± 1.0 days, n = 5) (p = 0.70). This first-in-human prospective study establishes the feasibility and early safety of the percutaneous ultrasound gastrostomy technique, with successful PUG insertion performed in all 25 participants
Summary
Percutaneous gastrostomy tube insertion involves the placement of a feeding tube through the abdominal wall directly into the stomach for enteral nutrition in individuals unable to tolerate per-oral intake. Common indications for gastrostomy tube insertion include ischemic or traumatic neurologic injury, head and neck cancer, esophageal cancer, recurrent aspiration, and other reasons for a failed swallowing assessment. This common procedure is most often performed in one of two ways: with the assistance of upper endoscopy (percutaneous endoscopic gastrostomy; PEG) or under fluoroscopic guidance (percutaneous radiologic gastrostomy, or PRG, sometimes referred to as radiologically inserted gastrostomy, or RIG). Both techniques require specialized equipment and are typically performed in dedicated procedural suites, competing for room time with other endoscopic and fluoroscopic procedures. CT guidance has been suggested for some complex gastrostomy tube insertions, which competes with diagnostic scans [2]
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