Role of 3-Dimensional Sonography in the Assessment of Submucous Fibroids: A Pilot Study.

OBJECTIVES: To investigate the accuracy and reliability of 3-dimensional (3D) transvaginal sonography in classifying submucous fibroids using the International Federation of Gynecology and Obstetrics PALM-COEIN (polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial, iatrogenic, and not yet classified) classification and protrusion (percent) compared to 2-dimensional (2D) transvaginal sonography, 2D saline infusion sonography, and 3D saline infusion sonography, using hysteroscopy as a reference test. METHODS: A prospective cohort pilot study was performed among 14 consecutive patients undergoing hysteroscopic surgery, preceded by routine sonography (2D transvaginal sonography, 2D saline infusion sonography, 3D transvaginal sonography, and 3D saline infusion sonography). RESULTS: The intraclass correlation coefficient (ICC) for 2D transvaginal sonography versus hysteroscopy was 0.69 (95% confidence interval [CI], 0.06, 0.90) compared to 0.94 (95% CI, 0.83, 0.98) for 2D saline infusion sonography. The ICCs for 3D transvaginal sonography versus hysteroscopy were 0.69 (95% CI, 0.03, 0.90 [investigator A]) and 0.55 (95% CI, -0.48, 0.86 [investigator B]). The ICCs for 3D saline infusion sonography versus hysteroscopy were 0.94 (95% CI, 0.81, 0.98 [investigator A]) and 0.87 (95% CI, 0.60, 0.96 [investigator B]). Interobserver agreement of 3D transvaginal sonography was 0.81 (95% CI, 0.43, 0.94) compared to 0.86 (95% CI, 0.56, 0.96) for 3D saline infusion sonography. CONCLUSIONS: In these preliminary data, 3D transvaginal sonography was not as accurate as 2D or 3D saline infusion sonography and was not more accurate than 2D transvaginal sonography. There was moderate interobserver agreement for 3D transvaginal sonography. There might be room for improvement, as 3D transvaginal sonography is more accurate when endometrial thickness increases. Further study is warranted to evaluate in which patients saline infusion sonography eventually can be obviated.

Three-dimensional saline infusion sonography compared to two-dimensional saline infusion sonography for the diagnosis of focal intracavitary lesions.

BACKGROUND: Focal abnormalities most commonly acquired within the uterine cavity include endometrial polyps (arising from the endometrium) and submucous fibroids (arising from the myometrium). These benign abnormalities can cause several problems, including abnormal uterine bleeding (AUB) and subfertility. Two-dimensional saline infusion sonography (2D SIS) is a minimally invasive test that can be used to diagnose these pathologies, but it is less accurate than hysteroscopy, which is a more invasive procedure by which an endoscope allows direct visualisation of the uterine cavity. Three-dimensional (3D) SIS appears to enhance sonographic visualisation within the uterine cavity, thereby offering a potentially more accurate minimally invasive diagnostic test. OBJECTIVES: Primary objectives • To evaluate the diagnostic accuracy of 3D SIS (index test 1) compared with 2D SIS for the diagnosis of focally growing lesions (presence or not) in women with AUB or subfertility, with hysteroscopy performed as the reference test. • To evaluate the diagnostic accuracy of 2D+3D SIS (index test 2) compared with 2D SIS for the diagnosis of focally growing lesions (presence or not) in women with AUB or subfertility, with hysteroscopy performed as the reference test. In this case, any abnormality on either modality was regarded as a positive result ('OR' approach). Secondary objectives • To evaluate the diagnostic accuracy of 3D SIS (index test 1) compared with 2D SIS according to type of abnormality and discrimination between uterine polyps and submucous fibroids in women with AUB or subfertility, with hysteroscopy and histology used as the reference.• To evaluate the diagnostic accuracy of 2D+3D SIS (index test 2) compared with 2D SIS according to type of abnormality and discrimination between uterine polyps and submucous fibroids in women with AUB or subfertility, with hysteroscopy and histology used as the reference. SEARCH METHODS: We searched the following databases: Cochrane Central Register of Studies Online (CENTRAL CRSO), MEDLINE, Embase, PubMed, Cochrane Gynaecology and Fertility Group (CGF) Specialised Register and CGFG Diagnostic Test Accuracy (DTA) Specialised Register, clinicaltrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Screening reference lists of appropriate studies was also performed. We screened for eligibility all studies identified from inception until March 2016. We performed searches with no date or language restrictions. SELECTION CRITERIA: The population of interest consisted of premenopausal women with AUB or subfertility and postmenopausal women with AUB. Diagnostic test accuracy studies, randomised controlled trials (RCTs) and prospective cohort studies were eligible for inclusion if they evaluated the accuracy of both 2D SIS and 3D SIS for the diagnosis of acquired intracavitary abnormalities with hysteroscopy used as the reference standard. In light of the lack of data for 3D SIS, we also included studies that evaluated the accuracy of 3D SIS alone. DATA COLLECTION AND ANALYSIS: Two review authors read all potentially eligible references after performing a first screening by title and abstract (LLN and FJRH). They independently extracted data to construct 2×2 tables from eligible studies and assessed studies for methodological quality using the QUADAS-2 tool (revised tool for quality assessment of diagnostic accuracy studies). To describe and visually present results, we produced in RevMan forest plots showing pairs of sensitivity and specificity together with 95% confidence intervals from each study, as well as raw receiver operating characteristic (ROC) plots. We displayed paired analyses in an ROC plot by linking sensitivity-specificity pairs from each study by using a dashed line. To compare 3D SIS versus 2D SIS, we restricted analyses to studies that provided 2×2 tables for both tests and used the bivariate meta-analysis of sensitivity and specificity. MAIN RESULTS: Thirteen studies (1053 women) reported the accuracy of 3D SIS for focal uterine abnormalities; 11 of these (846 women) were suitable for meta-analysis, and eight reported accuracy according to the type of focal abnormality. The design of the included studies seems applicable. The main problem involving the quality of included studies is insufficient reporting of study methods, resulting in unclear risk of bias for several of the quality domains assessed. Therefore, we considered the overall quality of the evidence as low. The summary estimate (11 studies reporting absence or presence of abnormality at 3D SIS) for sensitivity was 94.5% (95% confidence interval (CI) 90.6% to 96.9%) and for specificity 99.4% (95% CI 96.2% to 99.9%). Meta-analysis of the eight studies (N = 716) directly comparing 2D SIS versus 3D SIS showed summary sensitivity of 96.9% (95% CI 91.9% to 98.8%) and summary specificity of 99.5% (95% CI 96.1% to 100%) for 3D SIS. For 2D SIS, summary sensitivity was 90.9% (95% CI 81.2% to 95.8%) and summary specificity was 96.3% (95% CI 86.1% to 99.1%). The difference in accuracy between 2D SIS and 3D SIS was non-significant (P values of 0.07 for sensitivity and 0.10 for specificity). AUTHORS' CONCLUSIONS: Low-quality evidence suggests that 3D SIS may be very accurate in detecting intracavitary abnormalities. Meta-analysis revealed no statistically significant differences between 2D SIS and 3D SIS. Summary sensitivity and summary specificity are higher for 3D SIS, but margins of improvement are limited because 2D SIS is already very accurate. When the technology and appropriate expertise are available, 3D SIS offers an alternative to 2D SIS. Both 2D SIS and 3D SIS should be considered alternatives to diagnostic hysteroscopy when intracavitary pathology is suspected in subfertile women and in those with abnormal uterine bleeding.

The use of 3D power Doppler ultrasound in the quantification of blood vessels in uterine fibroids: feasibility and reproducibility.

BACKGROUND: To evaluate the interobserver agreement and discriminating value of three-dimensional power Doppler ultrasound (3D PDUS) in patients with fibroids. METHODS: An observational prospective cohort study in 19 patients with fibroids. 3D PDUS was performed by one examiner and evaluated by three independent examiners in order to evaluate various vascular parameters: vascular index (VI), flow index, and vascular flow index of the fibroid, the vascular capsule and of its highest vascular area, using both manual and automatic contour modes. The intraclass correlation coefficient and discriminating values were calculated. The correlation between VI and volume was studied using Kendall's Tau test. RESULTS: In the manual contour mode, the VIs of the fibroid and of the vascular capsule had the highest interobserver agreements (intraclass correlation coefficients of 0.89 and 0.87, respectively). Both parameters seem to have good discriminating values, given the large range of these parameters between different fibroids, independent of their volume. The vascularity of the fibroid and capsule was related. VI was not related to the volume of the fibroid. CONCLUSIONS: VI assessed using 3D PDUS is a reproducible parameter in the assessment of fibroid vascularization with discriminating abilities. Additional studies are needed to further evaluate its validity and clinical relevance.

Accuracy and Reproducibility of Sonoelastography for the Assessment of Fibroids and Adenomyosis, with Magnetic Resonance Imaging as Reference Standard.

The aims of this prospective diagnostic evaluation study were (i) to estimate the inter-observer agreement and reproducibility of real-time sonoelastography and real-time gray-scale ultrasound in the measurement of uterine and fibroid volumes; (ii) to evaluate the agreement between real-time gray-scale ultrasound, sonoelastography and magnetic resonance imaging with respect to these outcomes; and (iii) to evaluate the diagnostic accuracy of sonoelastography in the diagnosis of uterine pathology on stored sonoelastography and gray-scale cine loops. Women without a history of uterine pathology and with the diagnosis intrauterine fibroids or adenomyosis were included. All participants underwent gray-scale ultrasound, sonoelastography and magnetic resonance imaging. Compression sonoelastography was found to have high inter-observer and inter-method agreement for the measurement of uterine and fibroid volumes. The addition of sonoelastography to gray-scale ultrasound seems to be useful in the differentiation between fibroids, adenomyosis and normal uteri as reflected by an increase in accuracy and diagnostic agreement.

Diagnostic and clinical value of 3D gel installation sonohysterography in addition to 2D gel installation sonohysterography in the assessment of intrauterine abnormalities.

OBJECTIVE: To study the diagnostic value of three-dimensional gel instillation sonography (3D GIS) in addition to two-dimensional (2D) GIS in the assessment of intrauterine abnormalities. Secondly, the clinical value of 3D GIS in the planning for hysteroscopic procedures was evaluated. STUDY DESIGN: A prospective cohort study was performed from 2008 till 2010. All women with a suspected intrauterine abnormality on 2D GIS suitable for hysteroscopic resection or with recurrent postmenstrual bleeding were planned for a hysteroscopic procedure. Diagnostic accuracy tests were calculated for the detection of fibroids and polyps with both histology and hysteroscopy as the reference standard. For the assessment of type and size of fibroids hysteroscopy was used as the reference standard. We compared the planning for type of hysteroscopy based on 2D GIS findings with the combined 2D-3D GIS findings. RESULTS: In total 110 patients were analysed. In comparison to histology, addition of 3D GIS did not change sensitivity or specificity substantially in the discrimination between fibroids and polyps. In comparison to hysteroscopy, sensitivity increased for detecting fibroids and polyps, without major interference with the specificity. Despite an improved accuracy after the addition of 3D GIS, the planning for hysteroscopic procedures did not improve substantially. CONCLUSION: In daily practice, the addition of 3D GIS to 2D GIS improved the accuracy for the detection of polyps and fibroids compared to hysteroscopy, but only marginally improved the planning of hysteroscopic procedures, and therefore the clinical relevance seems to be limited.

Reproducibility of three-dimensional gel installation sonohysterography in the assessment and classification of intrauterine abnormalities.

OBJECTIVE: Purpose of this study is to determine the interobserver and intraobserver variability of 3D GIS in the assessment of intrauterine abnormalities. STUDY DESIGN: Forty five 3D volumes were randomly selected from a larger prospective cohort study that studied the diagnostic accuracy of 3D GIS in addition to 2D GIS. To study interobserver agreement volumes were reviewed by two independent examiners. One examiner reviewed these samples twice with an interval of 1 month in a random order. Interobserver and intraobserver agreement were tested with Cohen's kappa coefficient and shown in Bland and Altman plots. Quality of the 3D volumes was evaluated. RESULTS: Cohen's kappa for interobserver variability for type of abnormalities (none, polyp, fibroid, other) was 0.64 and for presence of a fibroid (fibroid yes/no) 0.77. Agreement on type of fibroid was 0.59. Intraobserver agreement was almost perfect for type of abnormality (Cohen's kappa of 1.0) and good for fibroid diameter. Quality of the 3D volumes was poor in 11 out of 45 cases. Reproducibility increased when poor quality images were excluded. CONCLUSION: Substantial interobserver and intraobserver agreement for 3D GIS in the diagnoses of intrauterine abnormalities was found. 3D GIS interobserver and intraobserver agreement are good for fibroid diameter and moderate for volume and protrusion.