Temporal Artery Biopsy vs ULtrasound in Diagnosis of GCA (TABUL) | Completed
Temporal Artery Biopsy vs ULtrasound in Diagnosis of GCA (TABUL)
TABUL
Trial Source

Health Conditions
  • Giant Cell Arteritis
Completed
Recruitment Status
NCT00974883
Primary Trial ID Number
Summary
Giant Cell Arteritis (GCA) causes inflammation and narrowing of blood vessels and can cause blindness in one third of patients. It is important that a prompt, accurate diagnosis of GCA is made and treatment given as steroids for two or more years. Currently there is no 100% accurate test for GCA. Patients usually have new headache and scalp tenderness, typically with an abnormal blood test. However, it can be difficult to distinguish non-serious forms of headache from GCA; infection produces similar abnormal blood results. If there is a suspicion of GCA, treatment with steroids is started straight away. To confirm a diagnosis, the patient will need a biopsy of a temporal artery (a minor procedure performed under local anaesthetic to remove a sample of one of the scalp arteries). However, up to 44% of patients will have a normal biopsy. Therefore it is difficult to know if a patient with a normal biopsy does or does not have GCA. Withdrawing steroid treatment may increase the risk of blindness. Continuing treatment in a patient without GCA increases the risk of side effects (e.g., weight gain, infection risk, osteoporosis and fracture risk, high blood pressure, diabetes, cataracts). It is important to improve diagnostic tests for GCA. Another test to help in diagnosing GCA is an ultrasound scan of the arteries in the side of the head and under the arms. Ultrasound does not involve surgery; it is a simple test which can be performed as an out patient. Gel is applied to both sides of the head and under each arm. A sound probe is placed over the artery at each site to produce the scan. The investigators' study will examine the role of ultrasound in diagnosis of 402 patients with suspected GCA. All patients will have an ultrasound examination in addition to biopsy within a week of starting steroids. Patients will be treated according to usual practice. After six months, the investigators will reassess the diagnosis. The investigators will look at the accuracy of ultrasound compared with or combined with biopsy. The investigators will look at how a doctor's knowledge of ultrasound results or biopsy results alone would affect the diagnosis and recommendation to continue or stop steroid treatment. The investigators will assess whether knowledge of both results together would alter the diagnosis and treatment. The investigators will collect information to estimate the costs of different ways of diagnosing GCA in relation to the impact on quality of life.
Primary Outcome Measures
  • To evaluate the diagnostic accuracy of ultrasound vs temporal artery biopsy for diagnosis of suspected GCA and to evaluate the cost-effectiveness (incremental cost per QALY) of ultrasound instead of biopsy in the diagnosis of GCA.; Six months
Secondary Outcome Measures
  • To evaluate inter-observer agreement in the assessment of ultrasound and temporal artery biopsy; Six months; To elicit expert views on the appropriateness of performing a biopsy following ultrasound using clinical vignettes; 3 years; To evaluate the diagnostic accuracy (sensitivity and specificity) of the sequential diagnostic strategy as an alternative to temporal artery biopsy alone in the diagnosis of GCA; 3 years; To evaluate the cost-effectiveness (incremental cost per QALY) of the diagnostic strategy of combined ultrasound and biopsy instead of biopsy alone in the diagnosis of GCA.; 3 years; Specific adverse events measured at each assessment; daily and cumulative steroid dose; steroid side effects; and pain or dysaesthesia at the biopsy site.; Six months; Evolution of an alternative diagnosis; Six months; Negative predictive value of ultrasound in preventing the need for temporal artery biopsies.; Six months; Cost analysis of performing a screening ultrasound examination plus biopsy as part of the diagnostic workup of all patients with suspected GCA; or of performing a screening ultrasound examination instead of biopsy; or of performing a screening ultrasound; Six months; Cost analysis of performing a screening ultrasound examination instead of biopsy in cases with a very low probability of GCA as part of the diagnostic workup of all patients with suspected GCA.; 3 years; Prediction of potential harm done to patients by over diagnosis or under diagnosis of GCA as a result of ultrasound use, either alone or in combination with biopsy; 3 years; Value of axillary artery ultrasound scanning in contributing to the diagnosis of GCA.; Six months; Analysis of proportion of patients with a biopsy positive halo, stenosis, or occlusion assessed by high resolution ultrasound; 3 years; Presence of characteristic features of GCA on temporal artery biopsy in relation to clinical and ultrasound findings; 2 weeks
Research Question
  • Giant Cell Arteritis (GCA) causes inflammation and narrowing of blood vessels and can cause blindness in one third of patients. It is important that a prompt, accurate diagnosis of GCA is made and treatment given as steroids for two or more years. Currently there is no 100% accurate test for GCA. Patients usually have new headache and scalp tenderness, typically with an abnormal blood test. However, it can be difficult to distinguish non-serious forms of headache from GCA; infection produces similar abnormal blood results. If there is a suspicion of GCA, treatment with steroids is started straight away. To confirm a diagnosis, the patient will need a biopsy of a temporal artery (a minor procedure performed under local anaesthetic to remove a sample of one of the scalp arteries). However, up to 44% of patients will have a normal biopsy. Therefore it is difficult to know if a patient with a normal biopsy does or does not have GCA. Withdrawing steroid treatment may increase the risk of blindness. Continuing treatment in a patient without GCA increases the risk of side effects (e.g., weight gain, infection risk, osteoporosis and fracture risk, high blood pressure, diabetes, cataracts). It is important to improve diagnostic tests for GCA. Another test to help in diagnosing GCA is an ultrasound scan of the arteries in the side of the head and under the arms. Ultrasound does not involve surgery; it is a simple test which can be performed as an out patient. Gel is applied to both sides of the head and under each arm. A sound probe is placed over the artery at each site to produce the scan. The investigators' study will examine the role of ultrasound in diagnosis of 402 patients with suspected GCA. All patients will have an ultrasound examination in addition to biopsy within a week of starting steroids. Patients will be treated according to usual practice. After six months, the investigators will reassess the diagnosis. The investigators will look at the accuracy of ultrasound compared with or combined with biopsy. The investigators will look at how a doctor's knowledge of ultrasound results or biopsy results alone would affect the diagnosis and recommendation to continue or stop steroid treatment. The investigators will assess whether knowledge of both results together would alter the diagnosis and treatment. The investigators will collect information to estimate the costs of different ways of diagnosing GCA in relation to the impact on quality of life.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Hunder GG, Bloch DA, Michel BA, Stevens MB, Arend WP, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, Lie JT, et al. The American College of Rheumatology 1990 criteria for the classification of giant cell arteritis. Arthritis Rheum. 1990 Aug;33(8):1122-8.; 2202311; Smeeth L, Cook C, Hall AJ. Incidence of diagnosed polymyalgia rheumatica and temporal arteritis in the United Kingdom, 1990-2001. Ann Rheum Dis. 2006 Aug;65(8):1093-8. Epub 2006 Jan 13.; 16414971; Borg FA, Salter VL, Dasgupta B. Neuro-ophthalmic complications in giant cell arteritis. Curr Allergy Asthma Rep. 2008 Jul;8(4):323-30. Review.; 18606086
Countries of Recruitment
Germany; Ireland; Norway; Portugal; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria: for the cohort study
  • 1. A clinical suspicion of new diagnosis of GCA e.g. patients with a new onset of
  • headache, scalp tenderness, with or without elevated CRP or ESR, jaw or tongue
  • claudication with or without visual loss.
  • 2. The clinician decides that the patient requires an urgent temporal artery biopsy to
  • determine whether or not the diagnosis is GCA.
  • 3. The patient agrees and provides NHS consent to undergo a temporal artery biopsy as
  • part of standard care.
  • 4. Patients have been started on high dose glucocorticoids or will be started on high
  • dose glucocorticoids.
  • 5. Patients must be willing to attend for an ultrasound scan of their temporal and
  • axillary arteries.
  • 6. Participants must be willing to give informed written consent or willing to give
  • permission for a nominated friend or relative to provide written informed assent if
  • they are unable to do so because of physical disabilities e.g. sudden onset of
  • blindness/vision loss which can be caused by GCA (this will be made clear in the
  • ethics approval application).
  • 7. Must be 18 years of age or over.
  • For the training cases
  • 1. Patients attending hospital outpatient or in patient departments for assessment for
  • any condition (apart from giant cell arteritis or polymyalgia rheumatica) or healthy
  • staff volunteers.
  • 2. Above the age of 50 years.
  • 3. Willing to attend for an ultrasound scan of their temporal and axillary arteries.
  • 4. Willing and able to give written informed consent.
  • Exclusion criteria: for the cohort study
  • 1. Previous diagnosis of GCA.
  • 2. Use of high dose glucocorticoid (>20mg prednisolone/day) for management of current
  • suspected GCA for more than 7 days prior to the dates of the ultrasound and biopsy.
  • 3. Long term (>1 month) high dose (>20mg per day at any time) steroids for conditions
  • other than PMR, within three months prior to study entry.
  • 4. Inability to give informed consent (either written consent or verbal assent from a
  • relative or carer)
  • 5. Inability to undergo an ultrasound scans of the temporal and axillary arteries.
  • 6. Patients with a known cause of headache (not due to GCA), or any condition which
  • would preclude the need for a temporal artery biopsy.
  • 7. Patients who are unable to undergo an ultrasound scan and a temporal artery biopsy
  • within 7 days of starting glucocorticoids.
  • For the training cases
  • 1. Diagnosis of suspected GCA or a previous history of diagnosed or suspected GCA.
  • 2. Inability to give written informed consent.
  • 3. Inability to undergo an ultrasound scans of the temporal and axillary arteries
Participant Exclusion Criteria
  • Inclusion Criteria: for the cohort study
  • 1. A clinical suspicion of new diagnosis of GCA e.g. patients with a new onset of
  • headache, scalp tenderness, with or without elevated CRP or ESR, jaw or tongue
  • claudication with or without visual loss.
  • 2. The clinician decides that the patient requires an urgent temporal artery biopsy to
  • determine whether or not the diagnosis is GCA.
  • 3. The patient agrees and provides NHS consent to undergo a temporal artery biopsy as
  • part of standard care.
  • 4. Patients have been started on high dose glucocorticoids or will be started on high
  • dose glucocorticoids.
  • 5. Patients must be willing to attend for an ultrasound scan of their temporal and
  • axillary arteries.
  • 6. Participants must be willing to give informed written consent or willing to give
  • permission for a nominated friend or relative to provide written informed assent if
  • they are unable to do so because of physical disabilities e.g. sudden onset of
  • blindness/vision loss which can be caused by GCA (this will be made clear in the
  • ethics approval application).
  • 7. Must be 18 years of age or over.
  • For the training cases
  • 1. Patients attending hospital outpatient or in patient departments for assessment for
  • any condition (apart from giant cell arteritis or polymyalgia rheumatica) or healthy
  • staff volunteers.
  • 2. Above the age of 50 years.
  • 3. Willing to attend for an ultrasound scan of their temporal and axillary arteries.
  • 4. Willing and able to give written informed consent.
  • Exclusion criteria: for the cohort study
  • 1. Previous diagnosis of GCA.
  • 2. Use of high dose glucocorticoid (>20mg prednisolone/day) for management of current
  • suspected GCA for more than 7 days prior to the dates of the ultrasound and biopsy.
  • 3. Long term (>1 month) high dose (>20mg per day at any time) steroids for conditions
  • other than PMR, within three months prior to study entry.
  • 4. Inability to give informed consent (either written consent or verbal assent from a
  • relative or carer)
  • 5. Inability to undergo an ultrasound scans of the temporal and axillary arteries.
  • 6. Patients with a known cause of headache (not due to GCA), or any condition which
  • would preclude the need for a temporal artery biopsy.
  • 7. Patients who are unable to undergo an ultrasound scan and a temporal artery biopsy
  • within 7 days of starting glucocorticoids.
  • For the training cases
  • 1. Diagnosis of suspected GCA or a previous history of diagnosed or suspected GCA.
  • 2. Inability to give written informed consent.
  • 3. Inability to undergo an ultrasound scans of the temporal and axillary arteries
Interventions
Procedure; Ultrasound of temporal and axillary arteries; Standardised assessment of temporal arteries and axillary arteries using high resolution ultrasound to detect halo, stenosis or occlusion; [Suspected GCA, Training cohort]; Procedure; Temporal artery biopsy; Biopsy of temporal artery from symptomatic side; [Suspected GCA]
Design Details
Sorry, this information is not available
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Results Reporting
Sorry, this information is not available
Acronym
TABUL
Scientific Title
The Role of Ultrasound Compared to Biopsy of Temporal Arteries in the Diagnosis and Treatment of Giant Cell Arteritis (GCA).
Secondary Trial Identifying Number
ISRCTN46280267
Website
http://www.ndorms.ox.ac.uk/clinicaltrials.php?trial=tabul; https://weblearn.ox.ac.uk/portal/hierarchy/medsci/department/ndorms/tabul
Study Funded By
University of Oxford
Funder Type
Sorry, this information is not available
Study Sponsored By
University of Oxford
Study Also Sponsored By
University of Sheffield; Southend University Hospital; Nuffield Orthopaedic Centre NHS Trust; Oxford University Hospitals NHS Trust; The Leeds Teaching Hospitals NHS Trust; University of Bristol; London School of Hygiene and Tropical Medicine; Medical Center for Rheumatology Berlin-Buch
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

09 Sep 2009

Last Updated

16 Jul 2015

Date Record Refreshed on UKCTG

31 Jul 2015