Percutaneous ultrasound gastrostomy (PUG): first prospective clinical trial

Abstract

Graphical abstarct: PURPOSE: To report the results of the first-in-human trial evaluating the safety and efficacy of the percutaneous ultrasound gastrostomy (PUG) technique.

Methods: A 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.

Results: 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 = 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).

Conclusion: 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.

Keywords: Gastrostomy; Percutaneous ultrasound gastrostomy; Ultrasonography.

Conflict of interest statement

The presented work was part of an industry-sponsored clinical research trial (sponsor—CoapTech). The study was conceived by the sponsor, but all data collection and analyses were done locally by the authors without sponsor oversight. The writing of all drafts of the manuscript and decision to publish were done by the authors alone. No external writing support was utilized. The authors have no financial relationship with the sponsor. The authors have no other relevant conflicts of interest to disclose.

© 2021. The Author(s).

Figures

Fig. 1

Breakdown of excluded and enrolled individuals. The number of individuals meeting each specific criterion within a category is shown in parentheses. Thirteen individuals met two exclusion criteria simultaneously

Fig. 2

Transabdominal ultrasound of the inflated orogastric balloon (arrow) within the gastric lumen. The orogastric balloon is being pulled against the anterior gastric wall via magnetic gastropexy. An 18-gauge needle (arrowhead) is advanced through the abdominal wall into the orogastric balloon, creating the gastrostomy tract

Fig. 3

Trend in length of procedure for PUG insertions. Procedure numbers displayed on the x-axis are in chronological order. Pearson Product-Moment Correlation shows a weak negative relationship (r = − 0.395)