Ventriculoperitoneal Shunt Malfunction Clinical Trial
Official title:
Clinical Value of Radionuclide Shuntography by Qualitative Methods in Hydrocephalic Adult Patients With Suspected Ventriculoperitoneal Shunt Malfunction
Verified date | May 2017 |
Source | Far Eastern Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | April 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Far Eastern Memorial Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety and Tolerability - Number of participants with treatment-related adverse events | Number of participants with treatment-related adverse events | 30 days post radionuclide shuntography | |
Primary | clinical outcome | subsequent need for revision, re-implantation or adjustment of shunt pressure. | 30 days post radionuclide shuntography | |
Secondary | surgical findings | findings (obstruction or not) noted by surgery | 30 days post radionuclide shuntography |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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