Intracranial CNS Disorder
Conditions
Keywords
AW frame, biopsy, stereotactic, accuracy, safety
Brief summary
This study is to establish a new, alternative stereotactic biopsy frame (AW frame) in the field of stereotactic neurosurgery.
Detailed description
AW frame is a stereotactic biopsy frame created by Dr. Albert Sii Hieng Wong. A phantom study had completed by Dr. Bik Liang Lau and Dr. Albert Sii Hieng Wong in year 2017 with good accuracy. The phantom study result is going to be submitted for publication by early 2019. With the good accuracy of AW frame in the phantom study, the frame has been approved by the Medical Research & ethic committee (MREC) for human use in a research setting. In the study, patient with intracranial lesion which required biopsy, whom fulfilled the criteria will be recruited. All these patient will underwent standard biopsy procedure either under local or general anaesthesia with AW frame mounted. A localisation CT scanning will be perform with localiser fixed onto the head frame. Target of the intracranial lesion is selected. The coordinates of the localizing points and the selected target inserted into the AW stereo-calculator to generate the AW frame setting up measurements. Burr hole will be performed and biopsy taken by using Nashold® biopsy needle. An immediate post-biopsy CT imaging will be performed to confirm the site of the biopsy. Patient will be monitored in the neurosurgery ward for any complications. Histopathologic analysis of the biopsies will be done using usual procedure.
Interventions
DEVICEAW frame
AW stereotactic frame for intracranial lesion biopsy
Sponsors
Ministry of Health, Malaysia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>17 years old * Radiological diagnosis of intracranial space occupying lesion of any etiology
Exclusion criteria
* Patient involved in other study trial * Any serious medical condition that according to the investigator could interfere with the conduct of the study * Unwillingness or inability to comply with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | For each patient 2 week after the biopsy | The diagnostic yield is defined as the number of patients in whom the histopathological diagnosis was made based of the biological material obtained during the biopsy. |
| Number of participants presenting with post-biopsy complications | an average of 2 week | The presence of acute postoperative complication is noted if any of following findings is present: wound site infection up to two weeks after the biopsy, a new neurological deficit developed up to 24 hours following the operation and present in a follow up clinical examination 2 weeks postoperatively, intraparenchymal hematoma with radiological evidence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time | From the time of the participant is transferred to the OR until the time of the participant transfer out of it, assessed on the day of operation. | the preparation, operation and total operating room time |
| Length of hospital stay | an average of 1 week | The preoperative, postoperative and total length of hospital stay |
Countries
Malaysia
Contacts
Primary ContactBik Liang Lau, MD
Backup ContactAlbert Sii Hieng Wong, FRACS
Outcome results
None listed