Sensitivity and Specificity of Color Doppler Directed Temporal Artery Biopsy as Compared to Standard Random Biopsy in the Diagnosis of Temporal Arteritis

Brief Title

Sensitivity and Specificity of Color Doppler Directed Temporal Artery Biopsy as Compared to Standard Random Biopsy in the Diagnosis of Temporal Arteritis


Brief Summary

      Introduction

      Temporal arteritis (TA) is the most common primary vasculitis in the adult population. TA is
      a systemic multi-organ disease but primarily involves the cranial arteries, especially the
      temporal artery. The signs and symptoms of the disease are variable and therefore the
      differential diagnosis is often difficult. The annual incidence of the disease in the
      population above the age of 50 in Jerusalem is about 10 per 100,000.

      Diagnosis is based on the clinical findings and confirmed by biopsy of the temporal artery,
      positive for histologic findings of arteritis. Though the biopsy procedure is minor and can
      be accomplished under local anesthesia, it is not without morbidity. Along with minor pain,
      more serious complications - facial nerve injury, ptosis, stroke, and local necrosis of skin
      - have been reported.

      A negative biopsy does not completely rule out the diagnosis of TA because of the segmental
      nature of the inflammation. Even if one removes an appropriate length of artery (usually 1-2
      cm) the possibility exists that an involved segment may not have been included and the biopsy
      will be reported as normal.

      It has recently been reported that color Doppler ultrasonography can be used to diagnose TA.
      Arterial inflammation causing peri-vascular edema appearing as a "dark halo" and segmental
      stenosis of the temporal artery are characteristic ultrasound findings suggestive of TA. If
      there is no dark halo sign, a diagnosis of TA cannot be supported and temporal artery biopsy
      can be avoided in most of these patients. The presence of the dark halo sign has a positive
      predictive value of only 50%.

      As noted above the disease is characterized by segmental involvement of the artery and to
      avoid a false negative biopsy, excision of up to 3cm of the artery has been recommended,
      thereby increasing the morbidity, and leading patients to refuse the procedure. Use of
      ultrasound-guided biopsy of the artery may dramatically raise the sensitivity and specificity
      of the biopsy and reduce the requirement for excising long segments of artery.

      Objective

      The objective of this study is to examine the use of ultrasound-guided biopsy of the temporal
      artery in the diagnosis of TA. Ultrasound-guided biopsy will be compared to the standard
      random biopsy generally in use. Appropriate statistical methods will be employed.

      Methods

      The Vascular Laboratory in Shaare Zedek Medical Center performs approximately 200 Doppler
      ultrasound studies of the temporal artery each year at the request of community-based
      physicians. Some of these patients are then also referred for biopsy of the temporal artery
      at various surgical facilities in the city. In collaboration with the referring physician,
      the patients will be offered a combined diagnostic Doppler ultrasound and guided biopsy on
      the basis of clinical guidelines and according to the ultrasound findings as described below.

      Patients suffering from signs and symptoms consistent with TA and who have not undergone
      previous temporal artery biopsy will be included.

      Patients suffering from isolated polymyalgia rheumatica will be excluded. Patients who are
      already undergoing steroid treatment will be excluded. Patients with an ultrasound study that
      is positive for the dark halo sign will be divided into two groups on a random basis after
      obtaining informed consent.

      One group will undergo ultrasound-guided biopsy, while the other will undergo biopsy as is
      the standard practice in our institution - a 1-2cm length of temporal artery will be excised
      from the preauricular area.

      If the ultrasound is negative, no biopsy will be done in the setting of this study.

      It is expected that about 50 patients will be accrued during the 6-month study period.
      Differences in outcome will be analyzed using Fishers exact test.

      Approval from the Helsinki committee of Shaare Zedek Medical Center has been requested.
    


Study Phase

Early Phase 1

Study Type

Interventional




Condition

Temporal Arteritis

Intervention

biopsy of temporal artery


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure


Start Date

August 2006

Completion Date

January 2007


Eligibility Criteria

        Inclusion Criteria:

          -  Patients suffering from signs and symptoms consistent with TA and who have not
             undergone previous temporal artery biopsy will be included.

        Exclusion Criteria:

          -  Patients suffering from isolated polymyalgia rheumatica will be excluded.

          -  Patients who are already undergoing steroid treatment will be excluded.
      

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

David Shemesh, MD, 972 - 2-6451692, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT00361192

Organization ID

TEMP ARTERITIS 001A



Study Sponsor

Shaare Zedek Medical Center


Study Sponsor

David Shemesh, MD, Study Director, Shaare Zedek Medical Center


Verification Date

August 2006