The Ventricular Catheter Placement Study: Assessment of Efficacy and Safety of an Ultrasound Guided Shunt Insertion Technique

NCT ID: NCT01007786

Last Updated: 2012-06-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-03-31

Brief Summary

Shunt failure remains a significant problem in pediatric patients with hydrocephalus. If reliable techniques for the accurate placement of ventricular catheters can be developed, shunt survival may improve. The purpose of this study is to assess the efficacy and safety of the ultrasound guided shunt insertion technique in the hands of experienced surgeons. The primary outcome measure is ventricular catheter location determined from post-operative brain images. The study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus. Pediatric neurosurgeons at HCRN centers enrolled in this study will perform either ultrasound guided shunt surgery or a conventional shunt surgery. Patients who undergo conventional shunt surgery will serve as a contemporary control group.

Conditions

Pediatric Hydrocephalus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients must have clinical and radiographic evidence of hydrocephalus as determined by a pediatric neurosurgeon and require a ventriculoperitoneal shunt (atrial, pleural, gallbladder and other shunt systems are excluded)
• Patients can have no prior history of shunt insertion for hydrocephalus. A history of an external ventricular drain, subgaleal reservoir-catheter, or subgaleal shunt is permissible
• Patients must be less than 18 years of age at the time of shunt insertion

Exclusion Criteria

• Active CSF or abdominal infection
• Spread of tumor in the subarachnoid space documented on enhanced imaging (CT or MRI) of the head or spine
• CSF leak without hydrocephalus
• Pseudotumor cerebri
• Dandy-Walker malformation or arachnoid cyst as a cause of hydrocephalus
• Loculations within the ventricular system
• Hydranencephaly, alobar holoprosencephaly or any other congenital anomaly of the brain that severely distorts the ventricular anatomy such that ventricular catheter location cannot be determined
• Other systemic disorders that would preclude the insertion/revision of a ventricular shunt
• Other difficulties that would preclude follow-up at one year (e.g. terminal illness with life expectancy less than 1 year)

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Whitehead, MD, MPH

Role: STUDY_CHAIR

HCRN, Texas Children's Hospital

Jay Riva-Cambrin, MD

Role: PRINCIPAL_INVESTIGATOR

HCRN, Primary Children's Medical Center

Abhaya Kulkarni, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

HCRN, Sick Children's Hospital, Toronto, Ontario

Jay Wellons, MD

Role: PRINCIPAL_INVESTIGATOR

HCRN, Children's Hosptial of Alabama

John Kestle, MD

Role: PRINCIPAL_INVESTIGATOR

Chair, Hydrocephalus Clinical Research Network

Locations

Children's Hospital of Alabama

Birmingham, Alabama, United States

Texas Children's Hospital

Houston, Texas, United States

Primary Children's Medical Center

Salt Lake City, Utah, United States

Sick Children's Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

References

Whitehead WE, Riva-Cambrin J, Wellons JC 3rd, Kulkarni AV, Holubkov R, Illner A, Oakes WJ, Luerssen TG, Walker ML, Drake JM, Kestle JR; Hydrocephalus Clinical Research Network. No significant improvement in the rate of accurate ventricular catheter location using ultrasound-guided CSF shunt insertion: a prospective, controlled study by the Hydrocephalus Clinical Research Network. J Neurosurg Pediatr. 2013 Dec;12(6):565-74. doi: 10.3171/2013.9.PEDS1346. Epub 2013 Oct 11.

Reference Type: DERIVED

PMID: 24116981 (View on PubMed)

Related Links

http://www.hcrn.org

Hydrocephalus Clinical Research Network

Other Identifiers

32371

Identifier Type: -

Identifier Source: org_study_id

HCRN 002

Identifier Type: OTHER

Identifier Source: secondary_id

1RC1NS068943-01

Identifier Type: NIH

Identifier Source: secondary_id

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