Ultrasound-guided versus stereotactically navigated ventriculoperitoneal shunt placement: a randomized clinical trial

BACKGROUND: Accurate catheter positioning is essential for optimal outcomes in ventriculoperitoneal shunt (VPS) surgery, while shorter operative times lower infection risk and costs. Navigated VPS placement, using either intraoperative ultrasound-guided (US-G) or stereotactically guided (ST-G) navigation, enhances catheter accuracy and reduces revision rates. However, high-quality studies comparing the two navigation methods are lacking. We aim to compare surgical intervention time, accuracy, and safety of US-G to ST-G VPS placement. METHODS: The Navigated VPS (NAVPS) trial was an investigator-initiated, randomized trial conducted from February 2020 to June 2024 in the Neurosurgical Department of the University Hospital of Basel. Consecutive adults undergoing VPS placement were included. Out of 153 screened participants, 134 participants were included. Participants were randomized 1:1 to receive either US-G or ST-G insertion of the ventricular catheter. The primary outcome was surgical intervention time. An intention to treat analysis was performed calculating surgical intervention time differences. Secondary outcomes were accuracy of catheter positioning, number of ventricular puncture attempts, and VPS dysfunction and complication rates. The study follow-up lasted 6 months. RESULTS: Of 134 participants, 66 were assigned to US-G and 68 to ST-G. The mean (SD) age was 73 (55.3 to 78) and 66 (54.5 to 73) years for the US-G and ST-G, respectively, and 58 participants (45.7%) were female. The US-G group had significantly shorter surgical intervention times compared to the ST-G group (-11.5 min; 95% CI -18.5 to -4.5; P = 0.002). The number of ventricular puncture attempts was significantly higher in the US-G group, while accuracy of catheter placement, and VPS dysfunction and complications rates were comparable in both groups. CONCLUSIONS: The NAVPS trial shows US-G VPS placement to be more time-efficient, while accuracy of catheter placement and complication rates seem to be comparable to ST-G placement. US-G can be efficiently and safely used in clinical practice. TRIAL REGISTRATION: clinicalTrials.gov Identifier: NCT04450797, date of registration: 22.06.2020.