- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03585699
Percutaneous Fluoroscopic vs CT Guided Core Needle Biopsy for Spinal Infection and Tumor
Accuracy, Safety and Diagnostic Outcome of Percutaneous Fluoroscopic vs. CT Guided Transpedicular Core Needle Biopsy for Spinal Infections and Tumors. A Prospective Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective randomized study was carried out in a single institution from November 2016 to June 2018.
Patients were recruited by three spine surgeons from the same institution after eligibility assessment. Sixty consecutive patients were randomized equally into fluoroscopic and CT guided spinal biopsy groups. Randomization procedure was performed using a computer generated random number sequence on www.random.org. Separate individuals completed the random allocation sequence, patient enrollment and outcome assessment. Outcome assessors were blinded to group assignment.
Data collection Clinical data collected were: patient demographics, comorbidities, infective parameters, tumor markers, Magnetic Resonance Imaging (MRI) findings and pre-biopsy pain score at rest using visual analogue scale (VAS). Intraoperative data included radiation exposure dosage, biopsy duration and complications encountered. Following biopsy, we recorded the biopsy result, 6-hourly pain score (VAS) at for 48 hours, additional analgesia requirement and complications.
Radiation measurement Commercial optically stimulated luminescence dosimeters, OSLDs (NanoDotTM Dosimeter, Landauer Inc, Glenwood, IL) were used to measure radiation dose. Ten OSLDs were placed on patients and doctors prior to all biopsies over selective areas representing radiosensitive organs. Placements of the OSLDs were done by a single observer. OSLDs were processed using MicroStar OSLD reader system (Landauer, Inc. Glenwood, IL). Each OSLD was processed 3 times during each reading to obtain a mean value to minimize error. The absorbed doses were measured in centigrays (cGy). Bleaching/zeroing of the OSLDs were done using optical annealing system containing fluorescent lamps (Osram lumilux, 24 W, 280 ~780 nm) in between each use of OSLDs.
Biopsy technique Transpedicular approach with an 8-gauge T-Lok™ bone marrow biopsy needle (Argon Medical Devices, Athens, TX, USA) was used in both arms. 10cc 2% lignocaine was infiltrated prior to biopsy. Biopsy needle was tapped gently with mallet through the pedicle and into the lesion under imaging guidance. Trocar was then withdrawn once it reached the affected area. The cannula was rotated several times to disengage sample from surrounding tissue. Then, aspiration of samples was done using 10-ml syringe prior to retraction of the cannula. Tissue samples were retrieved from the cannula with the use of stylet.
Samples collected were sent to laboratories for histopathological examination (HPE), culture and sensitivity (bacteriology, mycology and acid-fast bacilli), staining (Gram and Ziehl-Neelsen) and polymerase chain reaction (PCR) test for Mycobacterium tuberculosis.
- Fluoroscopy Guided Spinal Biopsy Arm: Fluoroscopy guided spinal biopsies were done by spine surgeons in the operation theatre using C-Arm fluoroscopy device (OECFluorostar7900Compact - GE®). C-arm image intensifier was positioned until fluoroscopic beam was collinear with the corresponding vertebral body on AP view prior to insertion of biopsy needle.
- CT guided Spinal Biopsy Arm: CT guided spinal biopsies were done by radiologist under guidance of 128-slice CT scanner (SOMATOM Definition AS+, Siemens Medical Solutions USA, Inc.). Preliminary axial CT scanning was done in bone window (window width, WW:2500; window level, WL:500) at the pre-selected levels decided from previous imaging to plan the needle access. Biopsy was then performed under sequential CT-fluoroscopy scan.
Post biopsy care Antimicrobials were commenced upon completion of biopsy for patients who were diagnosed to have spine infection. Disease progression was assessed based on clinical symptoms, ESR, CRP and/or MRI repeated during 6 months follow up for patients who were not treated for spinal infection.
For suspected spinal tumor cases, negative biopsies that were reported to have inadequate sample, were repeated with the other method or other investigation modalities will be resorted accordingly. Patients with negative biopsy that was reported to have adequate sample were follow up for 6 months for disease progression.
Sample size Sample size was determined based on accuracy of biopsy as outcome variable, in which the accuracy rate was 0.89. It was estimated using G*Power software (version 3.1.9.2) based on 2 proportions formula (Fisher's exact test). With alpha level of 0.05, 95% confidence interval and power of study 0.8, a minimum number of 52 patients (26 patients for each arm) was required for this study.
Statistical analysis Data were analyzed with SPSS Inc., Chicago, IL (SPSS v 23). Continuous data were reported as mean ± standard deviation and compared using t test. Chi-squared testing was used for between-groups comparisons. Fisher-exact test was used for the comparison of diagnostic accuracy between fluoroscopic and CT guided spinal biopsy. A p-value of <0.05 was considered significant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age more than 18;
- Patients who presented with clinical symptoms and radiological features suggestive of infection or malignancy;
- MRI reported as probable infection or tumour.
Exclusion Criteria:
- Cervical spine lesion;
- Significant neurological deficit that required urgent surgery;
- Partially treated spinal infections;
- Vascular tumour;
- Infection over skin puncture site;
- Pregnancy;
- Bleeding diathesis;
- Medically unfit for spinal biopsy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Fluoroscopy Guided Spinal Biopsy Arm
Fluoroscopy guided spinal biopsies were done by spine surgeons in the operation theatre using C-Arm fluoroscopy device (OECFluorostar7900Compact - GE®).
C-arm image intensifier was positioned until fluoroscopic beam was collinear with the corresponding vertebral body on AP view prior to insertion of biopsy needle
|
Spinal biopsy done via Transpedicular approach with an 8-gauge T-Lok™ bone marrow biopsy needle under fluoroscopic guidance. Samples collected were sent to laboratories for histopathological examination (HPE), culture and sensitivity (bacteriology, mycology and acid-fast bacilli), staining (Gram and Ziehl-Neelsen) and polymerase chain reaction (PCR) test for Mycobacterium tuberculosis. |
Active Comparator: CT guided Spinal Biopsy Arm
CT guided spinal biopsies were done by radiologist under guidance of 128-slice CT scanner (SOMATOM Definition AS+, Siemens Medical Solutions USA, Inc.).
Preliminary axial CT scanning was done in bone window (window width, WW:2500; window level, WL:500) at the pre-selected levels decided from previous imaging to plan the needle access.
Biopsy was then performed under sequential CT-fluoroscopy scan.
|
Spinal biopsy done via Transpedicular approach with an 8-gauge T-Lok™ bone marrow biopsy needle under CT guidance. Samples collected were sent to laboratories for histopathological examination (HPE), culture and sensitivity (bacteriology, mycology and acid-fast bacilli), staining (Gram and Ziehl-Neelsen) and polymerase chain reaction (PCR) test for Mycobacterium tuberculosis. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy of fluoroscopic and CT guided spinal biopsy
Time Frame: 6 months
|
Diagnostic accuracy were determined based on true positive, true negative, false positive and false negative biopsy findings
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation expose to patients and doctors
Time Frame: During biopsy
|
Total of 10 commercial optically stimulated luminescence dosimeters (OSLDs) were placed on patients and doctors at different body areas prior to biopsy to measure radiation dose
|
During biopsy
|
Pre biopsy and post biopsy pain score assessed by visual analogue scale (VAS)
Time Frame: 48 hours post biopsy
|
Pre biopsy pain score and post biopsy pain score (6-hourly for 48 hours) were assessed base on visual analogue scale (VAS) and recorded.
Pain score will be aggregated by mean and standard deviation and compared between both groups.
Additional analgesia requirement was documented.
|
48 hours post biopsy
|
Complications of spinal biopsy
Time Frame: During and 48 hours after spinal biopsy
|
Complications of spinal biopsy were observed such as neurovascular injury and iatrogenic fracture.
|
During and 48 hours after spinal biopsy
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Chris Yin Wei Chan, University of Malaya
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Neoplasms
- Neoplasms by Site
- Musculoskeletal Diseases
- Spinal Cord Diseases
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Spinal Diseases
- Bone Diseases
- Spondylitis
- Bone Diseases, Infectious
- Bone Neoplasms
- Spinal Cord Neoplasms
- Spinal Neoplasms
- Discitis
Other Study ID Numbers
- NMRR-16-690-30761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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