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Percutaneous Fluoroscopic vs CT Guided Core Needle Biopsy for Spinal Infection and Tumor

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ClinicalTrials.gov Identifier: NCT03585699
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Lee She Ann, University of Malaya

Brief Summary:
Spinal biopsy is important to obtain culture and histopathological diagnosis in spine infection and tumors. To date, there is no prospective randomized study comparing both techniques. Therefore, the aim of this prospective randomized trial was to evaluate the accuracy, safety and diagnostic outcome of both these techniques.A prospective randomized trial was performed in 60 patients divided equally into fluoroscopic and CT guided spinal biopsy groups. Transpedicular approach was done with 8G core biopsy needle. Specimens were sent for histopathological examinations and cultures. Diagnosis were made based on biopsy results, clinical criteria and disease progression during 6 months follow up. Radiation expose to patients and doctors were measured with optically stimulated luminescence dosimeters (OSLDs).

Condition or disease Intervention/treatment Phase
Spondylodiskitis Spinal Tumor Diagnostic Test: Fluoroscopy Guided Spinal Biopsy Diagnostic Test: CT guided Spinal Biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Separate individuals completed the random allocation sequence, patient enrollment and outcome assessment. Outcome assessors were blinded to group assignment.
Primary Purpose: Diagnostic
Official Title: Accuracy, Safety and Diagnostic Outcome of Percutaneous Fluoroscopic vs. CT Guided Transpedicular Core Needle Biopsy for Spinal Infections and Tumors. A Prospective Randomized Trial
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : June 2, 2018
Actual Study Completion Date : June 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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
Diagnostic Test: Fluoroscopy Guided Spinal Biopsy

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.
Diagnostic Test: CT guided Spinal Biopsy

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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age more than 18;
  2. Patients who presented with clinical symptoms and radiological features suggestive of infection or malignancy;
  3. MRI reported as probable infection or tumour.

Exclusion Criteria:

  1. Cervical spine lesion;
  2. Significant neurological deficit that required urgent surgery;
  3. Partially treated spinal infections;
  4. Vascular tumour;
  5. Infection over skin puncture site;
  6. Pregnancy;
  7. Bleeding diathesis;
  8. Medically unfit for spinal biopsy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585699


Locations
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Malaysia
University Malaya Medical Center
Kuala Lumpur, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Investigators
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Study Director: Chris Yin Wei Chan University of Malaya

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Responsible Party: Dr Lee She Ann, Orthopedic Registra, University of Malaya
ClinicalTrials.gov Identifier: NCT03585699     History of Changes
Other Study ID Numbers: NMRR-16-690-30761
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Lee She Ann, University of Malaya:
spinal biopsy
prospective randomizd trial

Additional relevant MeSH terms:
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Spinal Cord Neoplasms
Spinal Neoplasms
Discitis
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylitis
Bone Diseases, Infectious
Infection