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

NCT02894216 | Completed DMC

• 1 other identifier: 105026-E
• Study Type: observational
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ventriculoperitoneal Shunt Malfunction; Radionuclide Shuntography

Outcome Measures

Primary Outcomes (1)

• clinical outcome

  subsequent need for revision, re-implantation or adjustment of shunt pressure.

  30 days post radionuclide shuntography

Secondary Outcomes (1)

• surgical findings

  30 days post radionuclide shuntography

Other Outcomes (1)

• Safety and Tolerability - Number of participants with treatment-related adverse events

  30 days post radionuclide shuntography

Interventions

radionuclide shuntography PROCEDURE

the investigators retrospectively enrolled patient who received radionuclide shuntography

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• patients younger than 21 years old

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Officials

• Szu-Ying Tsai, MD

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: September 9, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share