The CSF Shunt Entry Site Trial

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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

Interventional


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)

Condition

Hydrocephalus

Intervention

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.

Publications

* 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

Procedure

Estimated Enrollment

448

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
             country);

          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.
      

Gender

All

Ages

1 Day - 17 Years

Accepts Healthy Volunteers

No

Contacts

William E Whitehead, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02425761

Organization ID

H-35639


Responsible Party

Principal Investigator

Study Sponsor

Baylor College of Medicine

Collaborators

 Patient-Centered Outcomes Research Institute

Study Sponsor

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


Verification Date

November 2020