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

NCT03585699 | Completed

• 1 other identifier: NMRR-16-690-30761
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Spondylodiskitis; Spinal Tumor

Keywords

spinal biopsy; prospective randomizd trial

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of fluoroscopic and CT guided spinal biopsy

  Diagnostic accuracy were determined based on true positive, true negative, false positive and false negative biopsy findings

  6 months

Secondary Outcomes (3)

• Radiation expose to patients and doctors

  During biopsy

• Pre biopsy and post biopsy pain score assessed by visual analogue scale (VAS)

  48 hours post biopsy

• Complications of spinal biopsy

  During and 48 hours after spinal biopsy

Study Arms (2)

Fluoroscopy Guided Spinal Biopsy Arm

ACTIVE COMPARATOR

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

CT guided Spinal Biopsy Arm

ACTIVE COMPARATOR

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

Interventions

Fluoroscopy Guided Spinal Biopsy DIAGNOSTIC_TEST

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.

Fluoroscopy Guided Spinal Biopsy Arm

CT guided Spinal Biopsy DIAGNOSTIC_TEST

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.

CT guided Spinal Biopsy Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

Location

MeSH Terms

Conditions

Discitis; Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Spondylitis; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Chris Yin Wei Chan

  University of Malaya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Separate individuals completed the random allocation sequence, patient enrollment and outcome assessment. Outcome assessors were blinded to group assignment.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Registra

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 13, 2018
• Study Start: November 1, 2016
• Primary Completion: June 2, 2018
• Study Completion: June 2, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

MY (1)