Background: Conventional transvaginal ultrasonography is widely used to evaluate endometrial abnormalities but may have limited ability to differentiate benign and clinically significant lesions. Ultrasound elastography provides additional information on tissue stiffness, which could enhance diagnostic performance. Objective: To compare the diagnostic accuracy of transvaginal ultrasound elastography and conventional ultrasonography for detecting endometrial pathology using histopathology as the reference standard. Methods: This comparative cross-sectional diagnostic accuracy study included 207 women at DHQ Hospital Landikotal, Khyber District, over six months. The participants were subjected to conventional transvaginal ultrasonography and ultrasound elastography, and then histopathologic examination was performed. Sensitivity, specificity, positive and negative predictive values, diagnostic accuracy, and receiver operating characteristic curves were evaluated. Results: Transvaginal ultrasound elastography showed a higher sensitivity than conventional ultrasonography (91.5% vs. 83.8%) and a higher specificity (81.5% vs. 73.8%). Elastography had an overall diagnostic accuracy of 88.4%, which was higher than conventional ultrasonography at 80.7%. The areas under the receiver operating characteristic curve were 0.884 and 0.788, respectively. Conclusion: In addition to conventional imaging, elastography may be helpful for providing complementary information regarding tissue stiffness and enhancing lesion characterization.
Endometrial pathology is a very broad term and can refer to endometrial hyperplasia, endometrial polyps, submucosal fibroids, and endometrial carcinoma.[1] The symptoms can include abnormal bleeding, infertility, irregular periods, or post-menopausal bleeding, and diagnosis is crucial and should be accurate and timely for proper management.[2] Endometrial carcinoma is a special case as it is the sixth most prevalent cancer in women globally, with an estimated 420,000 new cases and over 97,000 deaths in 2022.[3] Although many endometrial abnormalities are benign, distinguishing benign from premalignant and malignant lesions is crucial to avoid unnecessary invasive procedures and prevent delays in treatment.[1]
Transvaginal ultrasonography (TVUS) is the most widely used imaging modality for first-line evaluation of the endometrium because it is accessible, non-invasive, relatively inexpensive, and can assess endometrial thickness, morphology, echogenicity, and focal abnormalities.[4] Conventional ultrasound, however, might not be diagnostic in lesions with overlapping sonographic features, including how to differentiate between benign changes in the endometrium and hyperplasia or malignancy.[5]
However, endometrial thickness can be insufficient to diagnose tissue abnormalities in all clinical situations, and additional evaluation may be necessary with saline infusion sonography, hysteroscopy, or histopathological evaluation.[6] These factors emphasize the importance of complementary imaging modalities that can offer more information regarding endometrial tissue characteristics.[6]
Transvaginal elastography has recently been introduced as a promising tool in addition to conventional ultrasonography and has the potential to provide more information than just the anatomical appearance in terms of tissue stiffness and elasticity.[7] The technique evaluates the change in shape of tissue under pressure and/or the stiffness of tissue by recording the propagation of shear waves, depending on the type of elastography method used.[8] Pathological changes like fibrosis, cellularity, and malignant transformation could change the mechanical properties in the tissue, which can lead to better differentiation of endometrial lesions using elastography.[9]
In a prospective study of 217 women with endometrial lesions, transvaginal sonographic elastography demonstrated an area under the receiver operating characteristic curve (AUC) of 0.904, with 81.7% sensitivity and 85.0% specificity for differentiating endometrial cancer from benign lesions.[10] A later pilot study with 73 women also showed variations in tissue elasticity between a variety of endometrial and subendometrial abnormalities, including carcinoma versus hyperplasia, but mean elasticity was not significantly different between the two.[11] The results presented here suggest the great potential of elastography and highlight the need for further validation.[11]
Transvaginal ultrasonography is a commonly used method for assessing endometrial disease, but the sonographic characteristics of benign, premalignant, and malignant disease are similar, making distinction difficult. The results of transvaginal ultrasound elastography in determining tissue stiffness are encouraging; however, few studies have directly compared the diagnostic accuracy of transvaginal ultrasound elastography with conventional ultrasonography in a large number of patients with various endometrial diseases, especially in low-resource settings like Pakistan.
Moreover, variations in elastography techniques, diagnostic thresholds, and study populations highlight the need for locally generated evidence using histopathological examination as the reference standard. A paired comparison analysis of these modalities may be useful in determining if elastography offers useful additional diagnostic information, which may enhance patient selection for endometrial sampling and limit unnecessary invasive investigations. The purpose of the present study was to compare the diagnostic value of transvaginal ultrasound elastography and conventional transvaginal ultrasonography for diagnosis of endometrial pathology with histopathological evaluation as the reference standard.
A comparative cross-sectional diagnostic accuracy study was conducted in the Department of Obstetrics and Gynaecology and the Radiology Department of DHQ Hospital Landikotal, Khyber District, Khyber Pakhtunkhwa, Pakistan. The study was carried out for six months of the year, from 1 February 2026 to 31 July 2026. The sample size for a diagnostic accuracy study was calculated based on the expected sensitivity of transvaginal ultrasound elastography, using OpenEpi software with a 95% confidence level and an absolute precision of 8%. A previous prospective study published in 2019 evaluated transvaginal sonographic elastography for differentiating endometrial cancer from benign endometrial lesions and reported a sensitivity of 81.7%, specificity of 85.0%, and a disease prevalence of 47.9%, as the estimated total sample was 207 participants. A non-probability consecutive sampling technique was used to recruit participants. Patients were included if they were women aged 18 years or older with abnormal uterine bleeding, postmenopausal bleeding, sonographic findings suggestive of endometrial pathology, or other clinical findings suggestive of endometrial pathology. Eligible women were those who had been diagnosed with having lesions on the endometrium and who had had both conventional transvaginal ultrasonography and transvaginal ultrasound elastography, followed by histopathological diagnosis using endometrial biopsy, hysteroscopy-guided biopsy, or sampling for other clinically indicated reasons. Women who were pregnant, had active pelvic inflammatory disease or a contraindication to transvaginal ultrasonography, or had undergone hysterectomy were excluded. Patients who underwent a hormonal treatment likely to affect endometrial characteristics during the assessment period, patients with previously diagnosed endometrial malignancy during follow-up, and patients with technically inadequate ultrasound or elastography examination were also excluded. The primary diagnostic accuracy analysis excluded women whose results were not available as histopathology tests. Data were collected on a structured proforma after getting permission from the institutional ethical review committee and written informed consent from each subject. Demographic details, such as age, marital status, parity, menopausal status, BMI, and pertinent medical history, were collected. Clinical parameters consisted of the nature of the presenting complaint, duration of abnormal uterine bleeding (AUB), and pattern of AUB, history of pregnancy and delivery, and diabetes mellitus and/or history of hypertension. All patients first underwent conventional transvaginal ultrasonography and then also transvaginal ultrasound elastography. Examinations were carried out by a suitably trained radiologist with a transvaginal probe and a standard examination procedure. The conventional ultrasonographic features were endometrial thickness, endometrial morphology, endometrial echogenicity, focal lesions, and other uterine abnormalities. Elastography determined tissue stiffness and qualitative patterns of elasticity, and quantitative patterns of elasticity or strain ratios (as available). The examinations were recorded prior to histopathological findings, and the ultrasound assessments were made independent of the reference-standard results wherever possible. The reference standard was histopathological examination of specimens taken by biopsy or hysteroscopy. The histopathological diagnosis was classified as either normal or non-significant endometrium, endometrial polyp, endometrial hyperplasia, atypical hyperplasia or endometrial intraepithelial neoplasia, or endometrial carcinoma, as appropriate. To assess the efficacy of conventional ultrasonography and elastography in detecting endometrial pathology, the diagnostic results of conventional ultrasonography and elastography were compared with the histopathological results. Sensitivity, specificity, positive and negative predictive value, and overall diagnostic accuracy were determined for both imaging modalities. Receiver operating characteristic analysis was performed for quantitative elastography measurements. The collected data were entered and analyzed using IBM SPSS Statistics version 26. Normality of continuous variables such as age, body mass index, endometrial thickness, and quantitative elastography measurements was tested with the Shapiro–Wilk test. Data for normally distributed variables were presented as mean ± SD, and for non-normally distributed variables, median and interquartile range. Categorical variables such as menopausal status, presenting symptoms, ultrasound findings, and histopathological diagnosis were presented as frequencies and percentages. The overall accuracy of conventional transvaginal ultrasonography and transvaginal ultrasound elastography was compared to histopathology as the gold standard. The calculation of sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy with their 95% confidence intervals was performed. Quantitative elastography measurements were used to draw receiver operating characteristic curves, and the area under the curve was computed to quantify the overall discriminatory performance. An optimal cutoff for the quantitative elastography parameter was determined using the Youden index. A p-value of less than 0.05 was accepted as statistically significant.
The study included 207 participants with a mean age of 43.8 ± 11.6 years. The majority of participants were married and multiparous premenopausal women. The most common BMI category was overweight, and hypertension was reported more often than diabetes mellitus. Some participants had neither of these comorbidities. (Table 1)
Heavy menstrual bleeding was the most frequent presenting complaint, followed by irregular menstrual bleeding. The majority of the participants reported experiencing symptoms for 6 months or less. Conventional ultrasound showed variable thickness and morphology of the endometrium, and the most common morphological finding was a heterogeneous endometrium. There was an overall impression of suspected hyperplasia on ultrasound, but a subset of participants had no significant abnormality. (Table 2)
Histopathology revealed endometrial pathology in most participants, with the most common specific diagnosis being endometrial polyps and endometrial hyperplasia without atypia. A lesser number were found to have either atypical hyperplasia/endometrial intraepithelial neoplasia (EIN) or endometrial carcinoma. Elastography revealed the presence of varying tissue stiffness, as well as intermediate and mainly soft or elastic tissue. Hyperplasia was the most frequent suspected diagnosis on elastography. (Table 3)
Ultrasound elastography was more effective than conventional ultrasound in the diagnosis of endometrial disease. It showed higher sensitivity, specificity, positive and negative predictive values, and overall diagnostic accuracy, with fewer false-positive and false-negative results. The results indicate that elastography could enhance the diagnosis of endometrial abnormalities in conjunction with conventional ultrasound. (Table 4)
Quantitative elastography also discriminated better than conventional ultrasound using receiver operating characteristic analysis. The difference between the AUCs was statistically significant, and this argues for the added diagnostic value of measuring stiffness. (Table 5)
Table 1. Demographic and clinical characteristics of the study participants (n = 207)
|
Variables |
Frequency (n) |
Percentage (%) |
|
Age (years) |
||
|
Mean ± SD |
43.8 ± 11.6 |
— |
|
18–29 |
32 |
15.5 |
|
30–39 |
54 |
26.1 |
|
40–49 |
55 |
26.6 |
|
50–59 |
43 |
20.8 |
|
≥60 |
23 |
11.1 |
|
Marital status |
||
|
Married |
187 |
90.3 |
|
Unmarried |
20 |
9.7 |
|
Parity |
||
|
Nulliparous |
29 |
14.0 |
|
Primiparous |
34 |
16.4 |
|
Multiparous |
144 |
69.6 |
|
Menopausal status |
||
|
Premenopausal |
163 |
78.7 |
|
Postmenopausal |
44 |
21.3 |
|
BMI (kg/m²) |
||
|
Mean ± SD |
27.1 ± 4.8 |
— |
|
Normal weight (18.5–24.9) |
64 |
30.9 |
|
Overweight (25.0–29.9) |
85 |
41.1 |
|
Obesity (≥30.0) |
58 |
28.0 |
|
Comorbidities |
||
|
Diabetes mellitus |
39 |
18.8 |
|
Hypertension |
52 |
25.1 |
|
Neither diabetes nor hypertension |
137 |
66.2 |
Table 2. Clinical presentation and conventional ultrasound findings (n = 207)
|
Variables |
Frequency (n) |
Percentage (%) |
|
Presenting symptoms |
||
|
Heavy menstrual bleeding |
76 |
36.7 |
|
Intermenstrual bleeding |
37 |
17.9 |
|
Postmenopausal bleeding |
39 |
18.8 |
|
Irregular menstrual bleeding |
42 |
20.3 |
|
Other symptoms, including infertility or pelvic discomfort |
13 |
6.3 |
|
Duration of symptoms |
||
|
Less than 3 months |
83 |
40.1 |
|
3–6 months |
75 |
36.2 |
|
More than 6 months |
49 |
23.7 |
|
Endometrial thickness (mm) |
||
|
Mean ± SD |
12.4 ± 5.8 |
— |
|
≤5 mm |
31 |
15.0 |
|
6–10 mm |
64 |
30.9 |
|
11–15 mm |
57 |
27.5 |
|
>15 mm |
55 |
26.6 |
|
Endometrial morphology |
||
|
Uniform and regular |
73 |
35.3 |
|
Heterogeneous |
81 |
39.1 |
|
Focal lesion or irregular thickening |
53 |
25.6 |
|
Conventional ultrasound impression |
||
|
No significant pathology detected |
57 |
27.5 |
|
Endometrial polyp suspected |
53 |
25.6 |
|
Hyperplasia suspected |
61 |
29.5 |
|
Malignancy suspected |
36 |
17.4 |
Table 3. Histopathological diagnoses and elastography findings (n = 207)
|
Variables |
Frequency (n) |
Percentage (%) |
|
Histopathological diagnosis |
||
|
Normal or non-significant endometrium |
65 |
31.4 |
|
Endometrial polyp |
48 |
23.2 |
|
Endometrial hyperplasia without atypia |
43 |
20.8 |
|
Atypical hyperplasia/EIN |
23 |
11.1 |
|
Endometrial carcinoma |
28 |
13.5 |
|
Reference-standard classification |
||
|
No significant pathology |
65 |
31.4 |
|
Endometrial pathology present |
142 |
68.6 |
|
Quantitative elastography measurement |
||
|
Mean ± SD (illustrative stiffness measurement) |
42.6 ± 18.3 |
— |
|
Qualitative elastography impression |
||
|
Predominantly soft/elastic tissue |
79 |
38.2 |
|
Intermediate stiffness |
61 |
29.5 |
|
Predominantly stiff tissue |
67 |
32.4 |
|
Elastography interpretation |
||
|
No significant pathology suspected |
48 |
23.2 |
|
Endometrial polyp suspected |
52 |
25.1 |
|
Hyperplasia suspected |
65 |
31.4 |
|
Malignancy suspected |
42 |
20.3 |
Table 4. Diagnostic accuracy of conventional ultrasound and ultrasound elastography
for detecting endometrial pathology
|
Diagnostic parameter |
Conventional ultrasound |
Ultrasound elastography |
|
True positive (TP) |
119 |
130 |
|
False positive (FP) |
17 |
12 |
|
False negative (FN) |
23 |
12 |
|
True negative (TN) |
48 |
53 |
|
Sensitivity (%) |
83.8 |
91.5 |
|
95% CI for sensitivity |
77.0–89.2 |
85.6–95.1 |
|
Specificity (%) |
73.8 |
81.5 |
|
95% CI for specificity |
61.6–83.0 |
69.7–89.1 |
|
Positive predictive value (%) |
87.5 |
91.5 |
|
Negative predictive value (%) |
67.6 |
81.5 |
|
Overall diagnostic accuracy (%) |
80.7 |
88.4 |
Table 5. Receiver operating characteristic analysis of quantitative elastography
and comparison of diagnostic performance
|
Parameter |
Results |
|
Area under the ROC curve (AUC) for conventional ultrasound |
0.788 (95% CI: 0.725–0.851) |
|
Area under the ROC curve (AUC) for quantitative elastography |
0.884 (95% CI: 0.835–0.933) |
|
Difference in AUC |
0.096 |
|
DeLong test p-value |
0.012 |
|
Illustrative optimal elastography cutoff |
≥45 kPa |
|
Sensitivity at the illustrative cutoff |
91.5% |
|
Specificity at the illustrative cutoff |
81.5% |
|
Youden index |
0.730 |
In the present study, transvaginal ultrasound elastography was compared with conventional transvaginal ultrasonography in a group of 207 women, with the gold standard being histopathological examination, for the diagnosis of endometrial pathology. Elastography demonstrated higher sensitivity (91.5% vs. 83.8%), specificity (81.5% vs. 73.8%), and overall diagnostic accuracy (88.4% vs. 80.7%) than conventional ultrasonography. It also had a higher area under the receiver operating characteristic curve (AUC) (0.884 vs. 0.788), and thus better overall discrimination between normal and abnormal endometrial tissue. The results indicate a possible use of tissue stiffness measurement as an additional modality to standard ultrasound. One such study was performed by Vora et al who assessed the transvaginal shear-wave elastography in 73 women with histologically proven endometrial and subendometrial disease. They found a significant difference in mean values, minimum, and maximum elasticity values between pathological categories, with endometrial polyps showing a lower mean elasticity than some other lesions.[12] This is corroborated by our findings, which support the biological basis of our proposed results, as tissue stiffness may carry information beyond the anatomical features that can be evaluated by conventional ultrasound. However, Vora et al. studied the differences in elasticity between the pathological groups, but did not directly compare the overall diagnostic accuracy of elastography with traditional ultrasound. A larger study by Wang et al. assessed real-time transvaginal shear-wave elastography in 140 women with endometrial lesions and 100 women with normal endometrium. Mean elasticity values were substantially higher in endometrial carcinoma (49.36 ± 25.51 kPa) than in endometrial polyps (15.68 ± 8.18 kPa) and hyperplasia (21.20 ± 12.57 kPa). The findings suggest that the quantitative stiffness measurements could be a useful tool to characterize endometrial lesions.[13] On the other hand, a 2023 meta-analysis of eight studies and 432 endometrial cancer patients and 548 benign patients found shear-wave elastography to have 91% sensitivity, 90% specificity, and an AUC of 0.95.[14] The sensitivity of 91.5% and specificity of 81.5% in our study were broadly consistent with the pooled sensitivity, although the specificity was lower. Differences may reflect the broader definition of endometrial pathology in our study, variations in elastography equipment and thresholds, and differences in patient selection. Importantly, the meta-analysis was done with the intent to differentiate between cancer and benign lesions, while our proposed outcome encompassed benign abnormalities, including polyps and hyperplasia. These results are especially important to interpret when differentiating lesion characterization from definitive diagnosis. Vora's study showed that the mean elasticity was not significantly different between endometrial carcinoma and endometrial hyperplasia in the subgroup analysis (p = 0.19), although significant differences were seen among other pathological groups.[11] Evidence from studies of conventional transvaginal ultrasonography also helps explain the potential benefit of adding elastography. In women with uterine abnormalities, sensitivity is high, and specificity is relatively low for the combined use of the three techniques evaluated by Detti et al.: transvaginal ultrasound, saline infusion sonohysterography, and hysteroscopy. The sensitivity and specificity of conventional ultrasound for combined endometrial abnormalities were 88.9% and 56.7%, respectively.[15] These findings show how much it can be challenging to differentiate clinically significant lesions from common anatomical variants with conventional imaging. A comparison with our conventional ultrasound showed lower sensitivity at 83.8%, and specificity was higher at 73.8%. The variation may be attributable to differences in the populations studied, to the definition of the lesions, and to the referral patterns. Furthermore, Detti et al. examined different modalities of diagnosis other than elastography, and thus their conclusions indicate that there is a need for better characterization, not that elastography is superior.[15] Likewise, a prospective study was done at Baghdad Teaching Hospital and published in 2022, which included 60 women who were subjected to office hysteroscopy, ultrasonography, and histopathology. They discovered that the sensitivity of ultrasound was highly variable by type and was low for endometrial cancer and high for several focal cancers; hysteroscopy performed better in these latter cancers.[16] These observations validate the need not to use only traditional ultrasound when lesions appear alike. Our study showed that elastography might be an additional tissue characterization technique that could further decrease missed abnormalities, possibly because of hypothesized higher sensitivity. This interpretation is, however, preliminary, as it is based on different interpretation methods for hysteroscopy and elastography, and it is not possible to draw conclusions between the two methods from these results. In 2024, Ahmad et al. conducted a study in Pakistan that looked at transvaginal ultrasound and hysteroscopy in 150 women with AUB. Conventional ultrasound had a diagnostic accuracy of 83.5%, a sensitivity of 82.8%, and a specificity of 73.1%, while hysteroscopy had a diagnostic accuracy of 93.3%, a sensitivity of 94.9%, and a specificity of 84.6%.[17] In other Pakistani studies, the performance of conventional ultrasound has been shown to be dependent on population and the type of pathology that was being studied. In 2024, Kubra et al. examined 120 women who had postmenopausal bleeding and reported only 33.3% specificity and 83.3% sensitivity for transvaginal ultrasound compared to histopathology.[18] A study by Bashir et al. (2025) found an accuracy of 92.0% in a detection study of women with postmenopausal bleeding, with a sensitivity of 94.1% and a specificity of 88.9%.[19] Also, in 2023, Zaka et al. studied 165 patients who underwent transvaginal Doppler ultrasound for the detection of endometrial polyps and found a positive predictive value of 88.64%.[20] The Doppler assessment of vascular patterns does not assess tissue stiffness, but the study illustrated how more sonographic information might help to characterize focal endometrial lesions. Positive predictive value, however, depends on disease prevalence, and is not directly comparable to sensitivity, specificity, or overall accuracy. In another study published in 2025 by Bakhtawar et al., 112 women with AUB were included, and conventional ultrasound was 68.8% sensitive, 51.0% specific, and 53.6% accurate for detecting endometrial polyps. The positive predictive value was only 19.0%, despite a negative predictive value of 90.7%.[21] The results show that focal endometrial abnormalities can mimic polyps and lead to false-positive ultrasound diagnoses. Elastography might yield some additional information, but its ability to decrease such "false positive" results needs to be determined in each category of lesions. The study had several limitations. First, it was conducted at a single tertiary care hospital, which may limit the generalizability of the findings to other healthcare settings. Second, the relatively short study duration and limited sample size may have restricted the evaluation of less common endometrial abnormalities, particularly endometrial carcinoma. Third, the diagnostic performance of elastography may have varied according to the ultrasound equipment, operator expertise, measurement technique, and cutoff values used. Additionally, the inclusion of different endometrial pathologies may have influenced the overall estimates of sensitivity and specificity. Finally, histopathological verification was required for inclusion, potentially introducing selection bias because not all women undergoing ultrasound routinely undergo endometrial sampling.
Transvaginal ultrasound elastography demonstrated better diagnostic performance than conventional transvaginal ultrasonography for detecting endometrial pathology, with higher sensitivity, specificity, and overall diagnostic accuracy. The findings indicate that elastography could be a valuable tool in conjunction with traditional imaging, as it can provide more information regarding tissue stiffness and enhance lesion characterization. However, definitive diagnosis is still carried out with the help of histopathological examination. More multicenter trials with larger numbers and standardized elastography protocols would be needed to confirm these results and determine the clinical usefulness of this technique.
Alshewered, A.S., Endometrial hyperplasia, benign endometrial tumors and endometrial carcinoma: A review study. Romanian Medical Journal, 2024. 71(4): p. 423.