The CSF Shunt Entry Site Trial

Learn more about:
Related Clinical Trial
EVD Drainage Data and Intracranial Pressure (ICP) Measurements Caregiver Burden and Anxiety in Mothers of Children With Hydrocephalus Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies Pilot Study to Evaluate the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar Assessment of CSF Shunt Flow With Thermal Measurements B The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus: A Pilot Study Quantitative Pupillometry Pilot Study to Evaluate the CereVasc® eShunt® System US Pilot Study to Evaluate the CereVasc® eShunt® System Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation Combined Flow and Pressure Study of Craniospinal Dynamic Assessment of CSF Shunt Flow With Thermal Measurements Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)? Brain Aneurysms: Utility of Cisternal Urokinase Irrigation Three-step Disinfection Reduce the Postoperative Infection Rate of Ventriculoperitoneal Shunt Endoscopic Third Ventriculostomy for Adults: A Prognostic Model for Success The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt) Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ? Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients’ Treatment Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage Bactiseal Catheter Safety Registry in China Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement Hyperfine Portable MRI in Hydrocephalus Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries An Evaluation of a Non-invasive Brain Monitor An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device Assess Specific Kinds of Children Challenges for Neurologic Devices Study A Secondary Study Evaluating Aqueduct’s Smart External Drain (SED) Simulation Efficacy in Neurosurgical Education Intraoral 30% Glucose Effect In Newborns The Prediction of Intracranial Pressure and Clinical Outcome by Transcranial Doppler in Neurocritical Patients Impact of Ventricular Catheter Used With Antimicrobial Agents on Patients With a Ventricular Catheter Subgaleal Drains in Decompressive Craniectomies Role of Proteomics and Metallomics in Cerebral Vasospasm Following Subarachnoid Hemorrhage A Study Evaluate Aqueduct’s Smart External Drain Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH) Optimizing Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters Study of Ultrasound of the Eye for Children With Suspected Shunt Failure MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics Tablet-guided Versus Freehand (Tab-Guide) Ventriculostomy : Study Protocol to the Test Accuracy of Ventriculostomy in a Randomized Controlled Trial Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System. Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage Brain Ultrasound in the Weaning of External Ventricular Leads A Study on the Safety of Hakim Programmable Shunt System Thermal Camera Detection of Ventriculoperitoneal Shunt Flow Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability NIMIP: Non Invasive Measurement of the Intracranial Pressure Linking Digital Smartphone Behaviour With Brain Function Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains. Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement–Celda Infusion Subprotocol Strata Programmable CSF Shunt Valve Study The CSF Shunt Entry Site Trial Guided Application of Ventricular Catheters Value of MRI CSF Flowmetry in Assessment of Grey Zone Hydrocephalic Patients Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor Comparison of Optic Nerve Sheath Diameter Measured by Ultrasonography Before and After Ventriculoperitoneal Shunt Surgery in Adult Patients With Hydrocephalus CRT ShuntCheck “Fit & Function” Study Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk NIRS Monitoring in Premature Infants Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasound Before and After Drainage of Cerebrospinal Fluid in Patient With Hydrocephalus Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasonography Before and After Drainage of Cerebrospinal Fluid in Pediatric Patient With Hydrocephalus ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients Isoflurane-induced Neuroinflammation in Children With Hydrocephalus Hydrocephalus iPad-App Based Intervention Study Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus A Study Comparing Two Treatments for Infants With Hydrocephalus A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus Efficacy Study of Hydrocephalus Surgery by Methods of Neuroelectrophysiology Study of Choroid Plexus Cauderization in Patients With Hydrocephalus ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus BIS Monitoring of Patients With Hydrocephalus Magnetic Resonance Elastography in Hydrocephalus Noninvasive Intracranial Pressure and Hydrocephalus Patients Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Brief Title

The CSF Shunt Entry Site Trial

Official Title

A Randomized Controlled Trial of Anterior Versus Posterior Entry Site for Cerebrospinal Fluid Shunt Insertion

Brief Summary

      The purpose of the study is to compare the survival time (time to first shunt failure) of
      ventriculoperitoneal (VP) shunts inserted through an anterior entry site with those inserted
      through a posterior entry site in children. Shunt entry site is the location on the head that
      the shunt catheter enters the brain on its path to the fluid-filled spaces in the brain, the
      ventricles. Entry sites can be anterior or posterior.

Detailed Description

      The study is a multi-centered, randomized, controlled trial comparing two commonly used CSF
      shunt insertion techniques, anterior and posterior entry site. There is conflicting
      information and opinions in the pediatric hydrocephalus literature regarding entry site's
      effect on shunt survival. This trial is designed to detect a 10% or more difference in the
      rate of shunt survival at one year between the two techniques.

      The trial will be conducted by the Hydrocephalus Clinical Research Network and the
      Hydrocephalus Association. It is a four year study with an estimated sample size of 448
      patients. Patients will be randomized in the operating room. Subjects will be followed for a
      minimum of 18 months.

Study Phase

Phase 3

Study Type


Primary Outcome

Shunt Failure determined by clinical and radiographic findings

Secondary Outcome

 Patient quality of life measured by the Pediatric Quality of Life Inventory (PedsQL)




Ventriculoperitoneal shunt insertion surgery

Study Arms / Comparison Groups

 Anterior Entry SIte
Description:  Anterior entry site is defined as shunt surgery with catheter entry into the brain from an opening near the coronal suture, on the top of the head and near the front. Specifically, anterior entry is defined as ventricular catheter entry less than 1 centimeter anterior to the coronal suture near the mid-pupillary line.
Subjects randomized to this arm will undergo ventriculoperitoneal shunt insertion surgery using an anterior entry site.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

April 1, 2015

Completion Date

December 31, 2020

Primary Completion Date

December 31, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Less than 18 years of age at the time of shunt insertion; AND

          2. Clinical evidence of hydrocephalus that requires a simple ventriculoperitoneal shunt
             as determined by a pediatric neurosurgeon; AND

          3. No prior history of shunt insertion (a history of an external ventricular drain,
             ventricular reservoir, subgaleal shunt, and or endoscopic third ventriculostomy with
             or without choroid plexus coagulation is permissible); AND

          4. Ventriculomegaly on imaging.

        Exclusion Criteria:

          1. Need of a shunt that is not a simple ventriculoperitoneal shunt. For example: Patients
             who require more than one intracranial catheter are excluded. Patients who require a
             ventricular shunt that terminates in the atrium of the heart, the pleural cavity, the
             gallbladder, or any other terminal location that is not the peritoneal cavity are
             excluded. Patients who require a subdural to peritoneal or a cyst to peritoneal shunt
             are excluded.

          2. Active CSF or abdominal infection;

          3. CSF leak without hydrocephalus;

          4. Pseudotumor cerebri;

          5. Hydranencephaly;

          6. Loculations within the ventricular system (e.g. large intraventricular cysts or
             ventricular adhesions which create compartments that distort the ventricular anatomy;
             isolated trapped lateral ventricle). A small cyst within the ventricle does not meet
             these criteria;

          7. Other difficulties that would preclude follow up at one year (e.g. terminal illness
             with life expectancy less than 18 months; family plans to move out of region or

          8. A bilateral scalp, bone, or ventricular lesion that makes placement of either an
             anterior or a posterior shunt impracticable (e.g. cutis aplasia);

          9. Bilateral slit like frontal horns or trigones defined as the widest distance between
             the medial and lateral walls less than 3 millimeters.

         10. Patient is scheduled to have an intra-ventricular procedure (e.g. ETV, endoscopic
             biopsy, arachnoid cyst fenestration, fenestration of septum pellucidum) in addition to
             possible or definite VP shunt.




1 Day - 17 Years

Accepts Healthy Volunteers



William E Whitehead, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Baylor College of Medicine


 Patient-Centered Outcomes Research Institute

Study Sponsor

William E Whitehead, MD, Principal Investigator, Baylor College of Medicine

Verification Date

November 2020