BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study :
The rapid resurgence of tuberculosis (TB) prompted World Health
Organization (WHO) to declare “global emergency” in 1993. It is estimated that
each year more than 8 million new cases of TB occur and approximately 3 million
die of disease accounting for 26% of avoidable deaths. These numbers reflect the
delay in diagnosis and ineffectiveness of management.1,2
The causes for resurgence vary from country to country and include : co-
existing HIV infection, multi-drug resistance, treatment incompliance, underlying
systemic disease, social and economic disruption.3
Thirteen countries including India, abode to 75% of world’s TB cases will
largely determine whether the battle against TB is won or lost. 2
Extrapulmonary Tuberculosis (EPTB) exhibits more of a diagnostic problem
than pulmonary TB.
The reasons for inability and delay in diagnosis include low index of
suspicion, symptoms masked by antibiotics, it’s protean nature of manifestation
often resembling malignancy, non-responsiveness to treatment and lack of single
screening test such as chest radiography for pulmonary TB.4
Smaller number of bacilli at these sites and their relative inaccessibility
entails frequent need of invasive procedures to establish a diagnosis.
In the context of increasing number of specimens from extra-pulmonary sites
being sent for histology, we undertake this study to present our experience and
explicate characteristics of EPTB.
MATERIALS AND METHODS:
7.1 Source of data:
EPTB diagnosed at Pathology Department, JJMMC from May 2007 to April
7.2 Method of collection of data (including sampling procedure, if any):
Aspirated body fluid cytology
Histology suggestive of TB
History of previous TB treatment
Treatment AFB smear/culture
Treatment No treatment
Evaluation chart in a suspected case of EPTB.13
In accordance with the evaluation chart, specimens of excisional biopsies
from cases of EPTB, received in 10% formalin will be studied. Gross appearance
will be noted. Data regarding age, sex, presenting complaints, site of involvement,
results of relevant investigations, pre and post operative diagnosis, h/o previous
anti-tubercular therapy will be collected.
Histological reports will be separated into six categories
1) Necrotizing granulomas.
2) Non-necrotizing granulomas.
3) Poorly formed granulomas.
4) Fibrotic or hyalinized granulomas.
5) Acute inflammation.
Ziehl-Neelsen stain for AFB will be performed on sections. In recording the
AFB numbers determined in stained smears, following reporting scale will be
Score No. of bacilli
0 None [Negative]
+1 0-50 AFB/HPF [Weak positivity]
+2 50-100 AFB/HPF [Moderate positivity]
+3 >100 AFB/HPF [Strong positivity]
HPF will be taken at a magnification of x40.4
Sample size : Proposed to study 100 cases.
Inclusion criteria :
1) Histological diagnosis as “chronic granulomatous inflammation suggestive
of tuberculosis” from suspected cases and incidental cases.15
2) Associated / not associated with pulmonary TB.
3) With/without HIV positive status.
4) With/without AFB positivity.
1) Specimens from thoracic procedures as it is difficult to exclude extension
from pulmonary TB.
2) Non-tuberculous infectious granulomatous lesion.
3) Non-infectious granulomatous disease.
7.3 Does the study requires any investigations or interventions to be
conducted on patients or other humans or animals? If so, please describe
Yes, biopsy when indicated for diagnosis and resections for management
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes, ethical clearance has been obtained
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