The Ventricular Catheter Placement Study: Assessment of Efficacy and Safety of an Ultrasound Guided Shunt Insertion Technique
This study has been completed.
Sponsor:
University of Utah
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
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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
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
| 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 May 16, 2013