Efficacy of the Endo-pap sampler in detecting endometrial lesions

OBJECTIVE: To determine the efficacy of the Endo-pap sampler, a device used to collect endometrial tissue fragments for cytologic examination, in detecting endometrial lesions. STUDY DESIGN: Reports from 1,983 Endo-pap smears collected from 1,248 outpatients over a 44-month period were retrospectively examined in conjunction with corresponding biopsy or hysterectomy reports. Endo-pap smears, histologic sections and clinical information were reviewed in cases originally reported as abnormal. 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 carcinoma in 1 on histologic examination. Three were interpreted as malignant and one as suspicious; all had adenocarcinoma at endometrial biopsy. Endometrial abnormalities were reported in 19 of 220 patients who underwent endometrial biopsy following a previous Endo-pap smear reported as negative for malignancy. Their diagnoses included endometrial polyps (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 malignancy 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.