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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01007786
First received: November 2, 2009
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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.


Condition
Pediatric Hydrocephalus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Ventricular Catheter Placement Study: Assessment of Efficacy and Safety of an Ultrasound Guided Shunt Insertion Technique

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • The primary endpoint for the study is ventricular catheter location (VCL) as assessed on the first post-operative scan (US, CT, or MRI brain). [ Time Frame: The first post-operative scan will only be used in the study if it occurs within 105 days of shunt insertion. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Shunt survival will be reported. [ Time Frame: Up to one year after the date of shunt placement. ] [ Designated as safety issue: No ]
  • Any complications, intraoperative and postoperative, will be reported. [ Time Frame: From the time of surgery until the time the subject is discharged from the hospital. ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: December 2008
Study Completion Date: March 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric hydrocephalus patients undergoing first time shunt placement for hydrocephalus.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007786

Locations
United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
Canada, Ontario
Sick Children's Hospital
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
University of Utah
Investigators
Study Chair: William Whitehead, MD, MPH HCRN, Texas Children's Hospital
Principal Investigator: Jay Riva-Cambrin, MD HCRN, Primary Children's Medical Center
Principal Investigator: Abhaya Kulkarni, MD, PhD HCRN, Sick Children's Hospital, Toronto, Ontario
Principal Investigator: Jay Wellons, MD HCRN, Children's Hosptial of Alabama
Principal Investigator: John Kestle, MD Chair, Hydrocephalus Clinical Research Network
  More Information

Additional Information:
No publications provided by University of Utah

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01007786     History of Changes
Other Study ID Numbers: 32371, HCRN 002, 1RC1NS068943-01
Study First Received: November 2, 2009
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board
Canada: Research Ethics Board

Keywords provided by University of Utah:
Pediatric Hydrocephalus
Ultrasound Guided Surgery

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on September 18, 2014