Department of Obstetrics and Gynaecology of the University of Cagliari, Cagliari, Italy
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Abstract |
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Key words: CA125/colour Doppler energy/hydrosalpinx/pelvic inflammatory disease/transvaginal ultrasound
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Introduction |
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Materials and methods |
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The ultrasonographic unit was equipped with a colour pulsed Doppler ultrasonography system upgraded with CDE imaging. To avoid the risks of bias, conventional colour Doppler imaging evaluation was performed neither before nor after CDE imaging evaluation. The machine settings were fixed at the following parameters: log compression (dynamic range of energy signal) of 3540 dB, mix 4 (= most transparent), CDE post-processing 6, power <500, preprocessing 1, persistence 3 (= medium amount of smoothing), filter 3, gate setting 2. The Doppler study was performed by looking for colour signals along the wall and within the septa. When colour signals were detected, the pulsed Doppler gate was superimposed, and the pulsatility index (PI) and resistance index (RI) were electronically computed. When multiple signals were obtained from the same mass, the lowest PI and RI values were used for the statistical analysis. The intra-observer coefficient of variation was determined by analysing three sets of five consecutive waveforms from the vessel with the lowest PI and RI in the first 10 masses studied. The intra-observer variabilities for RI and PI were 3 and 4% respectively. Through B-mode ultrasonography, a hydrosalpinx was diagnosed using the previously described criteria (Timor-Tritsch et al., 1998) (Figure 1
). Using CDE imaging (CDE imaging evaluation of vessel distribution), the presence of an elongated shaped mass with incomplete septa with `poor' and peripheral vascularization was considered to indicate the likelihood of hydrosalpinx (Figure 3
). In addition a PI >1.0 or an RI >0.4 were considered characteristic of benign adnexal mass (Guerriero et al., 1998a
) and used to reduce the risk of misdiagnosis with ovarian cancer.
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The CA125 assays were performed with an immunoradiometric assay method by using two monoclonal antibodies (CIS Bio International, Gif sur Yvette, France). The intra- and interassay coefficients of variation were 3.9 and 4.2% respectively; the sensitivity was <0.5 IU/ml. A CA125 cut-off value of 25 IU/ml was considered to be characteristic of hydrosalpinx because in a previous retrospective study on 10 hydrosalpinges (unpublished data), we found that a value of CA125 >25 IU/ml was present in 100% of this type of adnexal mass.
The sonograms of each adnexal mass were obtained prospectively to evaluate the presence of hydrosalpinx. At surgery, all adnexa were carefully observed by two of the authors (V.M. and G.B.M.) and all adnexal masses were removed. The ultrasonographic impressions and the CA125 values were then compared with the final visual and histopathological diagnosis of hydrosalpinx which was defined as a liquid filled tube (Bloeche, 1999).
Statistics
In the first part of the study, to investigate the role of transvaginal ultrasonography in screening for hydrosalpinx, the sensitivity, specificity, and positive and negative predictive values of transvaginal ultrasonography were calculated for each visualized adnexum (Mais et al., 1993; Guerriero et al., 1998b
). To evaluate the overall agreement between a test result and the actual outcome, the kappa index was calculated according to a previously described method (Fleiss, 1981
); kappa-values ranging between 0.40 and 0.75 were assumed to indicate a strong agreement.
In the second part of the study, the sensitivity, specificity, positive and negative predictive values, and kappa-value of transvaginal ultrasonography and all combined methods were calculated for each adnexal mass (Mais et al., 1993; Guerriero et al., 1998b
). The z statistic for the comparison of two proportions (Glantz, 1981
) was used to evaluate the results. To evaluate the reproducibility of B-mode findings and assess the inter- and intra-observer variability in the interpretation of images (expressed in terms of k-values) (Mol et al., 1996
), the sonograms of each adnexal mass were independently reviewed by two gynaecologists (S.G. and S.A.) with different experience in transvaginal ultrasonography (11 and 5 years of experience respectively). In addition, for comparison of different percentages of distribution of vessels and the intensity of CDE signal in hydrosalpinges, other benign adnexal masses and malignant masses, the
2 statistic was used.
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Results |
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The ultrasonographic findings of the two false-positive cases were similar to findings considered characteristic for hydrosalpinx but pathological work-up revealed two serous cystadenomas. In the four false negative cases of B-mode ultrasonography, the presence of hydrosalpinx was missed but an alteration of normal uteroovarian relationship was always suspected due to the presence of pelvic adhesions. Therefore the sensitivity of transvaginal ultrasonography in the diagnosis of hydrosalpinx was 84.6%, with a specificity of 99.7%, and positive and negative predictive values of 91.7 and 99.4% respectively. The kappa index of 0.87 suggested a strong agreement between transvaginal ultrasonography and surgery.
In the second part of the study, the sensitivity of transvaginal ultrasonography in the differential diagnosis of hydrosalpinx was 93.3%, with a specificity of 99.6% and positive and negative predictive values of 93.3 and 99.6% respectively. The kappa index of 0.93 suggests a strong agreement between transvaginal ultrasonography and surgery. No increase in diagnostic accuracy was achieved by using colour Doppler or CA125 plasma concentration determinations (Table I). Kappa-values for reproducibility within observers and between observers were almost perfect (0.93 and 0.87 respectively).
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Discussion |
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The different results observed between a previous study (Atri et al., 1994) and the present study probably arise because the first study uses hysterosalpingography as the `gold standard' with the aim of detecting the distally occluded tube, which is a different entity from hydrosalpinx with different reproductive outcome (Bloeche, 1999).
The role of ultrasonography seems crucial also because only hydrosalpinges visible on ultrasound are associated with reduced implantation and pregnancy rates after in-vitro fertilization (de Wit et al., 1998; Strandell et al., 1999
). Theoretically, as a tube filled with fluid should be recognized as a cystic mass, all hydrosalpinges should be visible by ultrasound. Our study firstly demonstrated that this is not always true because some hydrosalpinges can be missed by ultrasound. As previously demonstrated in the diagnosis of dermoid cyst (Mais et al., 1995
), hydrosalpinx could also be missed because of the presence of faecal material and gas within the bowel in a pelvis distorted by other abnormalities. For these reasons the overall accuracy of ultrasonography is slightly reduced but, due to its higher sensitivity, this technique shows greater accuracy in comparison to magnetic resonance imaging (Outwater et al., 1998
) with lower costs. In addition, our study demonstrates the high reproducibility of the ultrasonographic findings. As stated previously (Timor-Tritsch et al., 1998
), it is critical to differentiate chronic tubal inflammatory disease from an ovarian malignant tumour. In our experience, this is easy and false negatives of ovarian cancer are absent because the presence of incomplete septa almost uniformly indicates the diagnosis of a Fallopian tube, since the true septa of ovarian tumours are very seldom, if ever, incomplete.
Several articles in the last 2 years have been specifically addressed to investigate and review the modern management of hydrosalpinx (Aboulghar et al., 1998; Lass, 1999
). For these reasons the diagnosis of hydrosalpinx with less invasive methods has aroused new interest associated with unexpected and controversial results. The use of B-mode transvaginal ultrasonography should be a preliminary test in the evaluation of an infertile couple because of the large amount of available information about the presence of pelvic adhesions (Guerriero et al., 1997
). The results of this study show that hydrosalpinges can also be suspected and identified with sufficient accuracy.
In the present study, we demonstrate that abnormal results at transvaginal ultrasound examination accurately identify patients with hydrosalpinx with a positive predictive value of 93.3%. Therapeutic considerations in this clinical situation include operative laparoscopy to remove the mass or IVF. In our opinion, operative laparoscopy is the first therapeutic choice due to the effect of hydrosalpinx on the results of IVF. Normal ultrasonography is also reliable because surgery generally confirmed the absence of hydrosalpinx. We found the false negative rate to be 2.6% and the negative predictive value to be 99.6%. These patients, if they desire pregnancy and the tubal patency is present, can postpone diagnostic laparoscopy for three to six cycles of in-vivo inseminations (Melis et al., 1995).
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Notes |
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References |
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Submitted on December 2, 1999; accepted on March 29, 2000.