Clinical Trials Directory

Trials / Completed

CompletedNCT02894216

Qualitative Radionuclide Shuntography for Adult Patients With Suspected V-P Shunt Malfunction

Clinical Value of Radionuclide Shuntography by Qualitative Methods in Hydrocephalic Adult Patients With Suspected Ventriculoperitoneal Shunt Malfunction

Status
Completed
Phase
Study type
Observational
Enrollment
69 (actual)
Sponsor
Far Eastern Memorial Hospital · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREradionuclide shuntographythe investigators retrospectively enrolled patient who received radionuclide shuntography

Timeline

Start date
2016-04-01
Primary completion
2017-01-01
Completion
2017-04-01
First posted
2016-09-09
Last updated
2017-05-11

Source: ClinicalTrials.gov record NCT02894216. Inclusion in this directory is not an endorsement.