A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain

Not Applicable

• Conditions: Intracranial CNS Disorder
• Interventions: Device: AW frame

• Registration Number: NCT03751085
• Lead Sponsor: Ministry of Health, Malaysia

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.

Study Timeline

• Study Start: 2018-07-18
• Status Verified: 2018-11
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-20
• Last Update Submitted: 2018-11-20
• Study First Posted: 2018-11-23
• Last Update Posted: 2018-11-23
• Primary Completion: 2020-07-17
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AW frame	AW frame	AW frame biopsy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Hospital Miri; 🇲🇾 Miri, Sarawak, Malaysia

Department of Neurosurgery, Hospital Sibu; 🇲🇾 Sibu, Sarawak, Malaysia

Department of Neurosurgery, Sarawak General Hospital; 🇲🇾 Kuching, Sarawak, Malaysia