NCT 00567554, www.clinicaltrials.gov.

Transvaginal hysterosalpingo-contrast-sonography (Hy-Co-Sy) is described as a new method for direct imaging of the tubal passage in tubal diagnostics. During one period of anaesthesia, a transvaginal Hy-Co-Sy was followed by either hysterosalpingography or chromolaparoscopy in 42 patients with sterility disorders. The contrast-enhanced sonography of the tubes was performed in eight cases with sterile saline solution (group 1) and 34 cases with a specially developed ultrasound contrast medium (SH U 454, group 2). The findings obtained by transvaginal Hy-Co-Sy were compared with those of the conventional method. By both methods, there was complete agreement with respect to the same evaluation of tubal passage for both sides, partial agreement when firstly the tubes were assessed as unilaterally or bilaterally open--without precise localization of the side--depending on the appearance of fluid in the pouch of Douglas, or secondly, only one side, when compared, showed agreement. In group 1 complete agreement was found once, partial agreement five times and non-agreement twice, while in group 2 complete agreement was found 22 times (65%), partial agreement 11 times and non-agreement once.

SummaryBackground: According to the literature, ductoscopy is gaining increasing importance in the diagnosis of intraductal anomalies in cases of pathologic nipple discharge. In a multicenter study, the impact of this method was assessed in comparison with that of standard diagnostics. Patients and Methods: Between 09/2006 and 05/2009, a total of 214 patients from 7 German breast centers were included. All patients underwent elective ductoscopy and subsequent ductal excision because of pathologic nipple discharge. Ductoscopy was compared with the following standard diagnostics: breast sonography, mammography, magnetic resonance imaging (MRI), galactography, cytologic nipple swab, and ductal lavage cytology. The histological and imaging results were compared and contrasted to the results obtained from the nipple swab and cytologic assessment. Results: Sonography had the highest (82.9%) sensitivity, followed by MRI (82.5%), galactography (81.3%), ductoscopy (71.2%), lavage cytology (57.8%), mammography (57.1%), and nipple swab (22.8%). Nipple swabs had the highest (85.5%) specificity, followed by lavage cytology (85.2%), ductoscopy (49.4%), galactography (44.4%), mammography (33.3%), sonography (17.9%), and MRI (11.8%). Conclusion: Currently, ductoscopy provides a direct intraoperative visualization of intraductal lesions. Sensitivity and specificity are similar to those of standard diagnostics. The technique supports selective duct excision, in contrast to the unselective technique according to Urban. Therefore, ductoscopy extends the interventional/diagnostic armamentarium.

The feasibility, diagnostic efficacy, and patient tolerance of a new diagnostic modality, hysterosalpingo-contrast sonography (HyCoSy), were evaluated in a clinical study of 120 patients with suspected infertility. A new echogenic contrast medium for ultrasound was administered transcervically with conventional tools for hysterosalpingography or a balloon catheter. The flow of multiple fractions of the contrast medium through each fallopian tube was observed in real time in appropriate imaging planes by means of a transvaginal probe. All patent tubes were diagnosed correctly with HyCoSy, results comparing well with findings at hysterosalpingography or laparoscopy. With B-mode scanning only, sensitivity was 88% for the right tube and 90% for the left; specificity was 100% for each tube. The supplementary use of Doppler techniques (duplex, color Doppler) provided additional information in special cases of suspected tubal occlusion and led to an improvement in diagnostic accuracy. The contrast agent was well tolerated. HyCoSy demonstrates normal anatomy and tubal patency with high reliability and permits advance selection of patients in whom more invasive diagnostic procedures may be required.

Cytogenetically, uterine leiomyomata are the best investigated human tumours. The most frequent clonal abnormalities are structural rearrangements involving 12q14-15 and deletions of part of the long arm of chromosome 7. The present study investigated a possible growth advantage conferred by these abnormalities, when compared with myomata having an apparently normal karyotype. A total of 155 myomata were included in the study. All samples were obtained after hysterectomy enabling karyotype analysis of all detectable tumours. Myomata with clonal chromosome abnormalities were significantly larger than those with a normal karyotype (6.8 +/- 5.3 versus 3.4 +/- 2.1 cm; P < 0.001). However, when differentiating between the two main aberrations, this was found to be true for the myomata with 12q14-15 changes affecting the high mobility group protein IC (HMGIC) gene (8.9 +/- 5.6 cm), but not for the group of tumours characterized by deletions of chromosome 7 (3.5 +/- 2.0 cm). The results are compatible with the hypothesis that myomata develop due to an unknown event, whereas the chromosomal abnormalities act as secondary changes, with those affecting the HMGIC gene increasing the growth potential of the corresponding tumours.