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

Primary Purpose

Ventriculoperitoneal Shunt (VPS), Hydrocephalus

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).
Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ventriculoperitoneal Shunt (VPS) focused on measuring Ventriculoperitoneal shunt (VPS)-dependency, VPS placement, Stereotactic Navigated Ventriculoperitoneal Shunt Placement, Ultrasound Guided (US-G) Ventriculoperitoneal Shunt Placement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurosurgery, University Hospital of BaselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

US -G VPS placement

Stereotactic navigation for VPS placement

Arm Description

Outcomes

Primary Outcome Measures

surgical intervention time (minutes)
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 Outcome Measures

Operation time (minutes)
Operation time (minutes): time in minutes from "cut" to "suture"
Anaesthesia time (minutes)
Anaesthesia time (minutes): time in minutes from "start anaesthesia" to "end anaesthesia"
Number of puncture attempts
Number of puncture attempts
Catheter placement (optimal vs. not optimal)
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)
Change in volumetry of side ventricles
Change in volumetry of side ventricles pre- and postoperatively in cm3 (number and relative change)
Change in Evan's Index
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.
rate of complications (infection, bleeding, complications associated with navigation method)
rate of complications (infection, bleeding, complications associated with navigation method)
mortality
mortality
revision surgery (yes/no)
revision surgery (yes/no)

Full Information

First Posted
June 22, 2020
Last Updated
October 17, 2023
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04450797
Brief Title
Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement
Acronym
NaVPS
Official Title
Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventriculoperitoneal Shunt (VPS), Hydrocephalus
Keywords
Ventriculoperitoneal shunt (VPS)-dependency, VPS placement, Stereotactic Navigated Ventriculoperitoneal Shunt Placement, Ultrasound Guided (US-G) Ventriculoperitoneal Shunt Placement

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The primary outcome is the surgical intervention time, recorded by blinded anaesthesiologists. Some of the secondary outcomes (catheter placement (optimal vs. not optimal, grade I to IV), volumetry of side ventricles, Evans' Index) are measured by a blinded neuroradiologist.
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
US -G VPS placement
Arm Type
Active Comparator
Arm Title
Stereotactic navigation for VPS placement
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).
Intervention Description
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 Outcome Measure Information:
Title
surgical intervention time (minutes)
Description
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.
Time Frame
at Operation day (V2, up to 24 hours)
Secondary Outcome Measure Information:
Title
Operation time (minutes)
Description
Operation time (minutes): time in minutes from "cut" to "suture"
Time Frame
at Operation day (V2, up to 24 hours)
Title
Anaesthesia time (minutes)
Description
Anaesthesia time (minutes): time in minutes from "start anaesthesia" to "end anaesthesia"
Time Frame
at Operation day (V2, up to 24 hours)
Title
Number of puncture attempts
Description
Number of puncture attempts
Time Frame
at Operation day (V2, up to 24 hours)
Title
Catheter placement (optimal vs. not optimal)
Description
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)
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)
Title
Change in volumetry of side ventricles
Description
Change in volumetry of side ventricles pre- and postoperatively in cm3 (number and relative change)
Time Frame
1 day before Operation day (V1, up to 24 hours) and 2-3 days post-op. (V3)
Title
Change in Evan's Index
Description
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.
Time Frame
before Operation day (V1) and 2-3 days post-op. (V3)
Title
rate of complications (infection, bleeding, complications associated with navigation method)
Description
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)
Title
mortality
Description
mortality
Time Frame
from Operation day (V2, up to 24 hours) until 6 months postop. (V6)
Title
revision surgery (yes/no)
Description
revision surgery (yes/no)
Time Frame
from Operation day (V2,up to 24 hours) until 6 months postop. (V6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Severina Leu, Dr. med.
Phone
0041 76 537 84 28
Email
Severina.Leu@usb.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Jehuda Soleman, PD Dr. med.
Phone
0041 78 623 44 88
Email
Jehuda.Soleman@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Severina Leu, Dr. med.
Organizational Affiliation
Department of Neurosurgery, University Hospital of Basel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luigi Mariani, Prof. Dr. med.
Organizational Affiliation
Department of Neurosurgery, University Hospital of Basel
Official's Role
Study Director
Facility Information:
Facility Name
Department of Neurosurgery, University Hospital of Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Severina Leu, Dr. med.
Phone
0041 76 537 84 28
Email
Severina.Leu@usb.ch
First Name & Middle Initial & Last Name & Degree
Claudia Huck
Phone
0041 61 328 79 23
Email
Claudia.huck@usb.ch
First Name & Middle Initial & Last Name & Degree
Jehuda Soleman, PD Dr. med

12. IPD Sharing Statement

Citations:
PubMed Identifier
34011396
Citation
Leu S, Halbeisen F, Mariani L, Soleman J. Intraoperative ultrasound-guided compared to stereotactic navigated ventriculoperitoneal shunt placement: study protocol for a randomised controlled study. Trials. 2021 May 19;22(1):350. doi: 10.1186/s13063-021-05306-5.
Results Reference
derived

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Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement

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