OBJECTIVE: To determine the efficacy of the Endo-pap sampler, a device
used to collect endometrial tissue fragments for cytologic examinatio
n, in detecting endometrial lesions. STUDY DESIGN: Reports from 1,983
Endo-pap smears collected from 1,248 outpatients over a 44-month perio
d were retrospectively examined in conjunction with corresponding biop
sy or hysterectomy reports. Endo-pap smears, histologic sections and c
linical information were reviewed in cases originally reported as abno
rmal. RESULTS: Endometrial abnormalities were reported in 29 Endo-pap
smears (1.5%). Among 21 reported as atypical, follow-up was normal in
19 but revealed hyperplasia in 1 and hyperplasia with a focus of carci
noma in 1 on histologic examination. Three were interpreted as maligna
nt and one as suspicious; all had adenocarcinoma at endometrial biopsy
. Endometrial abnormalities were reported in 19 of 220 patients who un
derwent endometrial biopsy following a previous Endo-pap smear reporte
d as negative for malignancy. Their diagnoses included endometrial pol
yps (14), hyperplasia without atypia (3), atypical hyperplasia (1) and
endometrial adenocarcinoma (1) three years after a negative Endo-pap
smear. CONCLUSION: Although the sensitivity and specificity for malign
ancy were 100%, the overall sensitivity for any pathologic lesion was
only 28%. We recommend proceeding directly to endometrial biopsy for a
conclusive diagnosis in symptomatic patients.