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Completed

NCT Number: NCT04450797

Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement

This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt (VPS) placement to stereotactic navigation in a randomized controlled fashion with the surgical intervention time as primary outcome. All patients entering the University Hospital of Basel for elective or emergent VPS surgery will be randomized in 1:1 fashion to one of the study groups at admission or the day before the operation.

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Key information

Conditions

Ventriculoperitoneal Shunt (VPS) Brain Diseases Central Nervous System Diseases Hydrocephalus Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurosurgery, University Hospital of Basel

Basel, 4031, Switzerland

About this study

Ventriculoperitoneal shunt (VPS) placement is one of the most frequent procedures in neurosurgical practice. The position of the proximal ventricular catheter is important since it influences possible malfunction of the VPS. For the improvement of accuracy in proximal VPS placement, navigation-based insertion techniques have been developed. VPS placement using stereotactic navigation has shown a high accuracy of catheter placement been developed. VPS placement using stereotactic navigation has shown a high accuracy of catheter placement, while the main limitations are that for referencing, the head of the patient needs to be fixed in a head holder and the preoperative set-up can be time-consuming. US-G VPS placement using a burr hole probe was described as an alternate for image-guided VPS placement technique. For US-G VPS placement head fixation or preoperative registration is not needed. This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt (VPS) placement to stereotactic navigation in a randomized controlled fashion with the surgical intervention time as primary outcome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed Consent as documented by signature
  • Patients undergoing elective or emergent VPS placement (frontal or occipital shunt )

Exclusion criteria

  • Revision surgery due to former VPS placement using the same side and location for VPS placement or when no complete shunt is revised (proximal and distal), resulting in a shorter operation time
  • Ventriculoatrial or ventriculopleural Placement
  • Women who are pregnant or breast feeding
  • Intention to become pregnant during the course of the study
  • Previous enrolment into the current study
  • Enrolment of the investigator, his/her family members, employees, and other dependent persons

Treatment and study plan

US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).

Device

US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).

Head not fixed, placed on horseshoe head holder, no preoperative navigation planning, catheter will be cut in length after positioning under real-time US guidance.

Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).

Device

Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).

Head fixed in head clamp, entry point, trajectory and catheter length planned based on preoperative computer tomography imaging, catheter placed using navigated stylet.

Primary outcomes

  1. surgical intervention time (minutes)

    Time frame: at Operation day (V2, up to 24 hours)

    time spent in the Operating Room (OR) by the surgeon, includes preparation time together (patient positioning, head clamping in the stereotactic navigation group) with the operation time of the neurosurgical part. Beginning ("positioning") and ending ("suture neurosurgical part") of this time interval is clearly defined and will be in a standardized manner recorded by blinded anaesthesiologists. . In the stereotactic navigation group, an additional 5 minutes will be added to the surgical intervention time for the preplanning of the navigation the day before the operation on the Brainlab workstation.

Secondary outcomes

  1. Operation time (minutes)

    Time frame: at Operation day (V2, up to 24 hours)

    Operation time (minutes): time in minutes from "cut" to "suture"

  2. Anaesthesia time (minutes)

    Time frame: at Operation day (V2, up to 24 hours)

    Anaesthesia time (minutes): time in minutes from "start anaesthesia" to "end anaesthesia"

  3. Number of puncture attempts

    Time frame: at Operation day (V2, up to 24 hours)

    Number of puncture attempts

  4. Catheter placement (optimal vs. not optimal)

    Time frame: at Operation day (V2,up to 24 hours), 2-3 days post-op. (V3), at discharge (V 4, approx. 7 days postop.), 6-8 weeks post-op (V5),6 months postop. (V6)

    Optimal catheter Placement: free-floating within the Cerebrospinal fluid (CSF) without touching ventricle wall or septum pellucidum, and the tip of the catheter located at the foramen of Monro showing an optimal length of the catheter. Catheters that did not fulfill all criteria have been defined as not optimal placed. Positioning of catheters will be further graded according to Yim et al. into grades I to IV (grade I: catheter terminates in the ipsilateral frontal horn, grade II: catheter terminates in contralateral frontal horn, grade III: catheter terminates in non-targeted CSF spaces, grade IV: catheter terminates intraparenchymally)

  5. Change in volumetry of side ventricles

    Time frame: 1 day before Operation day (V1, up to 24 hours) and 2-3 days post-op. (V3)

    Change in volumetry of side ventricles pre- and postoperatively in cm3 (number and relative change)

  6. Change in Evan's Index

    Time frame: before Operation day (V1) and 2-3 days post-op. (V3)

    Change in Evan's Index pre- and postoperatively (number and relative change).The Evans' index is the ratio of maximum width of the frontal horns of the lateral ventricles and the maximal internal diameter of the skull at the same level employed in axial CT images.

  7. rate of complications (infection, bleeding, complications associated with navigation method)

    Time frame: from Operation day (V2, up to 24 hours) until 6 months postop. (V6)

    rate of complications (infection, bleeding, complications associated with navigation method)

  8. mortality

    Time frame: from Operation day (V2, up to 24 hours) until 6 months postop. (V6)

    mortality

  9. revision surgery (yes/no)

    Time frame: from Operation day (V2,up to 24 hours) until 6 months postop. (V6)

    revision surgery (yes/no)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement: A Randomized Controlled Study

Acronym: NaVPS

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jun 30, 2020
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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