Article
GAVCA Study “Guided application of ventricular catheters” – A prospective randomized multicentre trial – current status of the study
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Authors
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Andreas Schaumann
- Klinik für Neurochirurgie/Pädiatrische Neurochirurgie, Charité – Universitätsmedizin Berlin, Berlin, Deutschland
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Ulrich-W. Thomale
- Klinik für Neurochirurgie/Pädiatrische Neurochirurgie, Charité – Universitätsmedizin Berlin, Berlin, Deutschland
| Published: | May 13, 2014 |
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Outline
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Objective: The accurate placement of the ventricular catheter (VC) in hydrocephalic patients is probably one of the most important factors for an uncomplicated long-term function of the drainage system. Freehand technique of catheter placement often does not offer sufficient accuracy to guarantee a perfect catheter placement within the ipsilateral ventricle. In our study the intraoperative freehand catheter placement is compared to the intraoperative guided application with a newly developed smartphone assisted guiding instrument.
Method: Within two years 144 patients will be randomly assigned to either the treatment group (guided application) or the control group (freehand application) in our prospective randomized two-armed national multicentre trial. After operation the catheter position will be documented in the regularly conducted postoperative scan (CT or MRI). A blinded neuroradiologist using a five-grade scale will evaluate the accuracy of the catheter tip placement. Patients are followed for 4 weeks in order to evaluate the early shunt failure rate and adverse events. The primary criterion (rate of catheter tip placement in the ipsilateral ventricle with grade of position I and Ib) will be evaluated using the one-sided chi-square test.
Results: The patient enrolment was started in April 2013, until end of November 2013 38 patients were successfully enrolled in 7 study centres (Berlin (2x), Kassel, Heidelberg, Tübingen, Neubrandeburg, Göttingen). Further study centres (Düsseldorf, Hannover, Essen) will be initialized. The patient recruitment is currently within the time schedule. Until the end of November 2013, no serious adverse events related to the operational treatment were reported.
Conclusions: Based on the first experience in our study, the use of the catheter guide seems to result in accurate VC placement even in quite narrow ventricles. The patient enrolment is slightly ahead of the time schedule, so the final study report will probably be ready in the third quarter of 2015.
