Overview

This trial is active, not recruiting.

Conditions ventriculoperitoneal shunt malfunction, radionuclide shuntography
Treatment radionuclide shuntography
Sponsor Far Eastern Memorial Hospital
Start date April 2016
End date April 2017
Trial size 100 participants
Trial identifier NCT02894216, 105026-E

Summary

The investigators retrospectively reviewed all radionuclide shuntographic tests using (99m)technetium-pertechnetate (DTPA) performed between August 2005 and December 2015 in nuclear medicine department of Far Eastern Memorial Hospital. The results of shuntography were evaluated visually and qualitatively, and correlated with clinical follow-up. The tests were interpreted as normal and abnormal, including complete distal obstruction, partial distal obstruction or miscellaneous. Clinical outcomes within 30 days were defined based on subsequent need for revision, re-implantation or adjustment of shunt pressure. Then the investigators calculated the sensitivity (Se), specificity (Sp), positive predictive value (PPV), negative predictive value (NPV) and overall accuracy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective

Primary Outcomes

Measure
clinical outcome
time frame: 30 days post radionuclide shuntography

Secondary Outcomes

Measure
surgical findings
time frame: 30 days post radionuclide shuntography

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - all radionuclide shuntographic tests using (99m)technetium-pertechnetate (DTPA) performed between August 2005 and December 2015 in nuclear medicine department in Far Eastern Memorial Hospital Exclusion Criteria: - patients younger than 21 years old

Additional Information

Official title Clinical Value of Radionuclide Shuntography by Qualitative Methods in Hydrocephalic Adult Patients With Suspected Ventriculoperitoneal Shunt Malfunction
Principal investigator Szu-Ying Tsai, MD
Description Introduction: Cerebrospinal fluid ventriculoperitoneal (V-P) shunts are often used in the treatment of hydrocephalus. Complications from shunts are not uncommon and can present with a variety of signs and symptoms, which could be evaluated by clinical examination and neuro-imaging. The radionuclide cerebrospinal fluid (CSF) shunt study provides a simple, effective, and low-radiation-dose method of assessing CSF shunt patency. When a discrepancy between neurological examination and imaging, additional radionuclide shuntography can be helpful. The purpose of the study was to analyze in the imaging findings and clinical interpretation of a variety of shuntography results and to determine the applicability of shuntography in patients with suspected shunt malfunction. Materials and Methods: The investigators include all radionuclide shuntographic tests using (99m)technetium-pertechnetate (DTPA) performed between August 2005 and December 2015 in our department. No complications or discomfort were noted in the examinations. The results of shuntography were evaluated visually and qualitatively, and correlated with clinical follow-up. The tests were interpreted as normal and abnormal, including complete distal obstruction, partial distal obstruction or miscellaneous. Clinical outcomes within 30 days were defined based on subsequent need for revision, re-implantation or adjustment of shunt pressure. Then the investigators calculated the sensitivity (Se), specificity (Sp), positive predictive value (PPV), negative predictive value (NPV) and overall accuracy. The investigators would also determine the correlation with operative findings and assessment of radionuclide shuntography.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Far Eastern Memorial Hospital.