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1 From the Department of Radiology, DC069.10, University of Missouri Health Sciences Center, One Hospital Dr, Columbia, MO 65212 (R.L.B.); the Departments of Radiology (R.A.B., S.D.) and Obstetrics and Gynecology (M.R.P.), University of Michigan, Ann Arbor, Mich; the Department of Radiology, Western Pennsylvania Hospital, Pittsburgh (M.B.V.); and the Department of Radiology, Harvard Medical School, Brigham and Women's Hospital, Boston, Mass (C.B.B., P.M.D.). Received June 11, 1999; revision requested August 9; revision received October 12; accepted October 26. Supported in part by a grant from the Society of Radiologists in Ultrasound Research and Education Fund. Address correspondence to R.L.B. (e-mail: breer@health.missouri.edu).
| ABSTRACT |
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MATERIALS AND METHODS: One hundred twenty-three patients with PMB underwent transvaginal ultrasonography (US) and HSG. They were examined for cancer, polyp, leiomyoma, and hyperplasia. Physicians assessed the effect of the studies on diagnostic confidence and care, including biopsy, dilation and curettage, hysteroscopy, hormone manipulation, and/or patient reassurance. Abnormality was proved with histopathologic evaluation, and normality, with 6-month follow-up.
RESULTS: In 10 patients, HSG was unsuccessful, and in 15, follow-up was incomplete; this left 98 patients. Endometrial polyps were seen in 46 (47%) patients; leiomyoma, in 11 (11%); cancer, in four (4%); hyperplasia, in eight (8%); and normal findings, in 29 (30%). Our calculations yielded a sensitivity of 98% and a specificity of 88%. In 86 (88%) patients, US added certainty to the diagnosis; in 78 (80%), it resulted in a change in patient treatment.
CONCLUSION: HSG and transvaginal US in patients with PMB improves diagnostic accuracy, clinical decision making, and the clinician's diagnostic certainty. In patients with benign causes of PMB, the absence of abnormality at HSG and a normal endometrial biopsy result may eliminate the need for further studies.
Index terms: Uterus, abnormalities, 854.1495, 854.315, 854.318, 854.3199, 854.33 Uterus, endometrium Uterus, US, 854.12981, 854.12983
| INTRODUCTION |
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There have been a number of studies to define the role of both transvaginal ultrasonography (US) and endometrial biopsy in patients with PMB (1,2,715). The results of studies have consistently shown that an ultrasonographically measured endometrial thickness of 4 or 5 mm or less almost completely excludes endometrial carcinoma. In most of the studies, endometrial biopsy was found to have a high sensitivity for the detection of endometrial cancerapproaching 95% when there was an adequate sample. However, Dubinsky et al (8) reported on 12 of 18 patients with endometrial cancer who had false-negative endometrial biopsy results. In most studies, a negative endometrial biopsy result or negative dilation and curettage result has been used as the criterion for the diagnosis of the cause of PMB. Unfortunately, tissue sampling from dilation and curettage is accurate for detecting endometrial cancer but relatively inaccurate for diagnosing or excluding other causes of PMB, such as endometrial polyps or leiomyomata (16).
HSG has been shown to be useful for evaluating the endometrium, particularly in patients with PMB. Even when the endometrial thickness is 5 mm or less, HSG is accurate in identifying an anatomic cause of the bleeding in some cases (3,5,1719). Alternatively, office hysteroscopy has been used to further examine patients with abnormal transvaginal ultrasonograms in an attempt to define an anatomic cause of the PMB (20). With these diagnostic issues in mind, we conducted a clinical trial to evaluate the accuracy of transvaginal saline-assisted HSG and assess the effect of this examination on diagnostic confidence and therapeutic clinical decision making among referring gynecologists and primary care physicians caring for patients with PMB.
| MATERIALS AND METHODS |
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Some patients presented after unsuccessful endometrial biopsy, which was often due to cervical stenosis. We did not exclude these patients from enrollment in the study, and in five of them, successful HSG was performed when cervical stenosis precluded endometrial biopsy.
The study protocol mandated that a patient either had to previously have undergone endometrial biopsy at least 7 days before the US examination or was scheduled to undergo biopsy within 1 month after the US examination. Not all patients underwent endometrial biopsy, primarily because of the unexpected number of abnormalities found on the hysterosonograms. In addition, each patient was required to be a candidate for a definitive therapeutic procedure such as dilation and curettage or surgical hysteroscopy.
The US examinations were performed by one of several authors with commercially available US machines (Siemens Medical Systems, Iselin, NJ; Advanced Technology Laboratory/Philips, Bothell, Wash; or Acuson, Sunnyvale, Calif). The examinations consisted of transvaginal US with or without color Doppler imaging and HSG with or without color Doppler imaging. Transvaginal US was used to examine both ovaries and the uterus. The uterus was examined for the presence of myometrial masses, and the endometrium was examined for an endometrial pathologic entity. The maximum thickness of the endometrium was measured at the fundus, body, and lower uterine segment on the sagittal view.
Saline-assisted HSG was performed after the insertion of a catheter through the cervix. Most of the catheterizations were performed with a 5-F catheter equipped with an inflatable balloon. Occasionally, a pediatric feeding tube was used. Sterile saline was injected into the endometrial cavity with real-time transvaginal US monitoring to evaluate the distention of the cavity. The endometrial cavity was examined for the presence of polyps, submucous leiomyomata, or other pathologic conditions. Color Doppler US was performed in most patients, particularly when abnormalities were identified. We carefully searched for a feeding vessel when a polypoid lesion was seen.
Before patient enrollment, the referring physicians were asked to complete an initial clinical decision form. This form contained demographic data, an initial clinical impression of the cause of the PMB, and the initial treatment plan before the performance of transvaginal US and HSG. Treatment plan options included watchful waiting, hormone manipulation, dilation and curettage, dilation and curettage and hysteroscopy, and hysterectomy. After transvaginal US and HSG had been performed, the referring physicians were asked to complete a second decision form, on which they were asked (a) whether the HSG results had facilitated a change in the original clinical impression and (b) their level of confidence in the new diagnosis. The clinical decision information from the referring physician was analyzed in two areas: (a) We asked whether the US findings added any degree of certainty to the diagnostic and treatment plan, and this was answered by using the following four-degree scale: none, little, some, or much. (b) We asked whether the US findings facilitated a change in patient treatment, and this was answered by using the following three-degree scale: no change, modest change, or substantial change.
A final pathologic diagnosis was made by using the results of the surgical procedurethat is, dilation and curettage, hysteroscopy, or hysterectomyand histopathologic analysis. In those patients who were not treated surgically, the final diagnosis was determined on the basis of the results of a 6-month follow-up clinical examination, which indicated either the cessation of symptoms or no evidence of further disease. By using surgical or 6-month follow-up information as the reference standard, the sensitivity, specificity, positive and negative predictive values, and accuracy of HSG were calculated. When there was no pathologic condition or the results of histopathologic analysis were negative at surgery, it was considered a negative result. Abnormal histopathologic findings included hyperplasia, polyps, leiomyoma, and carcinoma. We determined the accuracy of HSG for the detection of specific pathologic conditions in each positive case in which histopathologic confirmation was obtained.
| RESULTS |
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The 98 study patients ranged in age from 41 to 85 years (mean age ± SD, 56.6 years ± 8.6). Seventy-one patients were receiving hormonal replacement therapy. Seventy-five patients underwent endometrial biopsy, which was negative for cancer or nondiagnostic in all but four patients, who had endometrial carcinoma. In another five patients, endometrial biopsy was unsuccessful, but HSG was successful.
The HSG results in the 98 patients were as follows: normal in 29 (30%) patients, polyps in 46 (47%), leiomyomata in 11 (11%), cancer in four (4%), and hyperplasia in eight (8%). At HSG, 69 (70%) patients were found to have a pathologic condition that was responsible for the PMB; in 65 of these women, this finding was histopathologically proved. Twenty-nine (30%) of the HSG studies were negative, and the findings in 28 of these cases were histopathologically proved. These findings yielded a sensitivity of 98%, specificity of 88%, positive predictive value of 94%, and negative predictive value of 97% (Table 1).
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In 86 (88%) cases, the results of transvaginal US and HSG substantially influenced the diagnostic certainty for the referring physicians. In 78 (80%) cases, treatment decisions were influenced by the HSG results. In the patients with normal HSG results (n = 29), the degree of certainty was influenced to a notable degree in 25 (86%) cases, and treatment decisions were influenced in 18 (62%) cases (Table 2).
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| DISCUSSION |
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Transvaginal saline-assisted HSG, which is also called sonohysterography or hydrosonography, is performed by inserting a catheter into the endometrial cavity and injecting sterile saline solution while scanning transvaginally. The technique has been extensively described, and results indicate that its accuracy far exceeds that achieved with transvaginal US alone (7,8,17,19,20). To understand the clinical importance of HSG, we undertook this clinical trial to attempt to determine the role of HSG in clinical decision making and for diagnostic confidence in patients with PMB.
From a patient treatment perspective, determination of the presence or absence of endometrial cancer is the most important short-term outcome of testing. On the other hand, up to 50% of patients who are given prescriptions for hormonal replacement therapy do not continue taking the medication after 12 months. There are many reasons for this noncompliance, but an important one is the fear of uterine cancer, a fear that is exacerbated by unwanted bleeding episodes that have heretofore been unexplained (22). With HSG, a patient can be examined, and should an anatomic reason for the PMBfor example, a polypbe found, it can be removed. Other causes for the bleeding, such as leiomyomata, can be treated with ablative techniques, or the patient can be reassured that no malignancy is present (8).
Our study results indicate that the participating referring physiciansboth gynecologists and family practitionershad a high level of confidence in the results of the HSG examinations. In addition, gynecologists frequently changed their initial therapeutic plan after learning the results of HSG. This included changing a planned hysterectomy to watchful waiting, changing a dilation and curettage procedure to dilation and curettage plus hysteroscopy, and changing watchful waiting to hysterectomy.
With the diagnostic confidence levels and therapeutic decisions influenced by HSG results in the normal and abnormal groups in this study, we have proved that this examination has an important role in the evaluation and treatment of patients with PMB. In addition, although the reference standard in the literature is that endometrial thickness of 5 mm or less generally excludes carcinoma and other endometrial abnormalities, 22% of our study patients with polyps or leiomyomata had an endometrial thickness that was 5 mm or less (1) (Fig 3).
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In our series, the sensitivity, specificity, and positive and negative predictive values were very high. This suggests that HSG should become the reference standard method with which other technologies are compared. At analysis of the four false-positive cases in our study, we found that at least two patients were bleeding at the time of diagnostic hysteroscopy and dilation and curettage, and the gynecologist reported that no pathologic entity was found, although it seemed highly probable at HSG.
A pitfall that was responsible for at least one false-positive study was the presence of an endometrial blood clot, which was mistaken for a polyp (Fig 4).
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| FOOTNOTES |
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Author contributions: Guarantor of integrity of entire study, R.L.B.; study concepts, R.L.B.; study design, all authors; definition of intellectual content, R.L.B.; literature research, R.L.B.; clinical studies, C.B.B., R.L.B., R.A.B., M.B.V., P.M.D.; data acquisition and analysis, all authors; statistical analysis, R.L.B.; manuscript preparation, S.D., R.L.B., R.A.B., C.B.B., M.B.V.; manuscript editing and review, R.L.B., R.A.B., C.B.B., M.B.V.
| REFERENCES |
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