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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02894216
Other study ID # 105026-E
Secondary ID
Status Completed
Phase N/A
First received May 4, 2016
Last updated May 10, 2017
Start date April 2016
Est. completion date April 2017

Study information

Verified date May 2017
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
radionuclide shuntography
the investigators retrospectively enrolled patient who received radionuclide shuntography

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT05534659 - Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies