Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement (NaVPS)

October 17, 2023 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Department of Neurosurgery, University Hospital of Basel
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jehuda Soleman, PD Dr. med

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: US -G VPS placement
Device: US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at Operation day (V2, up to 24 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time (minutes)
Time Frame: at Operation day (V2, up to 24 hours)
Operation time (minutes): time in minutes from "cut" to "suture"
at Operation day (V2, up to 24 hours)
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"
at Operation day (V2, up to 24 hours)
Number of puncture attempts
Time Frame: at Operation day (V2, up to 24 hours)
Number of puncture attempts
at Operation day (V2, up to 24 hours)
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)
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)
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)
1 day before Operation day (V1, up to 24 hours) and 2-3 days post-op. (V3)
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.
before Operation day (V1) and 2-3 days post-op. (V3)
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)
from Operation day (V2, up to 24 hours) until 6 months postop. (V6)
mortality
Time Frame: from Operation day (V2, up to 24 hours) until 6 months postop. (V6)
mortality
from Operation day (V2, up to 24 hours) until 6 months postop. (V6)
revision surgery (yes/no)
Time Frame: from Operation day (V2,up to 24 hours) until 6 months postop. (V6)
revision surgery (yes/no)
from Operation day (V2,up to 24 hours) until 6 months postop. (V6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Severina Leu, Dr. med., Department of Neurosurgery, University Hospital of Basel
  • Study Director: Luigi Mariani, Prof. Dr. med., Department of Neurosurgery, University Hospital of Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2020

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-02157; ch20Leu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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