Percutaneous Ultrasound-Guided Core Needle Biopsy: Comparison of 16-Gauge versus 14-Gauge Needle and the Effect of Coaxial Guidance in 1065 Breast Biopsies - A Prospective Randomized Clinical Noninferiority Trial.

PURPOSE: Ultrasound-guided core needle biopsy (CNB) is considered the standard assessment to diagnose sonographically visible suspicious breast mass lesions. Based on nonrandomized trials, the current German guidelines recommend at least three cylinders with ≤ 14-gauge needle biopsy. However, no recommendation is made as to how many specimens are needed with a smaller needle size, such as 16-gauge, or if biopsy with coaxial guidance improves diagnostic accuracy and quality. Therefore, in a prospective monocentric unblinded randomized controlled clinical noninferiority trial, the diagnostic accuracy of 16-gauge versus 14-gauge core needle biopsy, with and without coaxial guidance, was evaluated. MATERIALS AND METHODS: 1065 breast biopsies were included in order to analyze the number of core samples necessary to obtain an appropriate rate of diagnostic quality adequate for histological evaluation, and to achieve high diagnostic accuracy and diagnostic yield. Histological results were verified by surgery or long-term follow-up of at least two years up to five years. RESULTS: In order to obtain an additive diagnostic accuracy of > 99 %, a minimum of two cylinders with 14-gauge biopsy were required. The diagnostic accuracy and the diagnostic quality of 14-gauge biopsy were not affected by the coaxial technique. When performing a 16-gauge biopsy, five cylinders were required to achieve an additive diagnostic accuracy of > 99 %. Without coaxial guidance, 16-gauge CNB required at least three samples, whereas five needle passes with coaxial-guided 16-gauge biopsy were needed. CONCLUSION: The diagnostic accuracy and quality of ultrasound-guided 16-gauge core needle biopsy were inferior to the 14-gauge needle size, regardless of the use of a coaxial technique.

Effect of probiotics on vaginal health in pregnancy. EFFPRO, a randomized controlled trial.

BACKGROUND: Preterm delivery is a leading cause of neonatal morbidity and death. It often results from chorioamnionitis, which is a complication of bacterial vaginosis. Probiotics are effective in the treatment of bacterial vaginosis in women who were not pregnant; studies in pregnant woman are missing. OBJECTIVE: The purpose of this study was to evaluate whether an oral probiotic food supplement supports the maintenance or restoration of a normal vaginal microbiota during pregnancy. STUDY DESIGN: We conducted a randomized, placebo-controlled, triple-blind, parallel group trial. Oral Lactobacillus rhamnosus GR-1and L reuteri RC-14 (109 colony-forming units) or placebo were administered for 8 weeks to women with <12 completed weeks of pregnancy. Participants were enrolled at Tuebingen University Hospital and 10 recruiting gynecologic practices. Vaginal swabs were taken before and after intervention and analyzed according to the Nugent scoring system. Telephone interviews were performed before and after intervention and after delivery. Primary outcome was the proportion of swabs with normal Nugent score (<4) after intervention, compared by Fisher's exact test in an intention-to-treat analysis. RESULTS: Three hundred twenty pregnant women were enrolled. Vaginal swabs were analyzed from 290 women before and 271 women after intervention. The proportion of normal vaginal microbiota decreased from 82.6 to 77.8% in the treatment group and from 79.1 to 74.3% in the placebo group, with no significant difference across groups after intervention (P=.297). CONCLUSION: Oral probiotics may be suitable for implementation in antenatal care but, as administered here, had no effect on vaginal health during mid gestation. Other application routes or probiotic preparations may be more effective in supporting vaginal microbiota during pregnancy.

Intraoperator and interoperator repeatability of manual and semi-automated measurement of increased fetal nuchal translucency according to the operator's experience.

OBJECTIVE: To compare the intraoperator and interoperator repeatability of manual and semi-automated measurement of increased nuchal translucency (NT) in sonographers with different levels of experience. METHODS: One hundred NT images without measurements were selected from the digital database. Half had NT measurements between 2.5 and 3.5 mm, and half had NT measurements above 3.5 mm. Five operators (two experts, three general gynaecologist) measured fetal NT manually and automatically. Each operator was blinded to any pre-existing measurements. Each image was measured twice by each operator. Intraoperator repeatability was assessed by standard deviation of within sonographer repeated measurement. Interoperator repeatability was assessed as difference towards the gold standard, which was defined as the mean measurement of experts. RESULTS: The overall standard deviation of the difference between the first and the second manual measurements was 0.14 and 0.10 mm for moderate and severely increased NT. It was 0.10 and 0.08 mm with the semi-automated system. Mean difference between the manual measurement of nonexpert operators and the gold standard was -0.01 mm for moderately increased NT and 0.02 mm for severely increased NT. With the semi-automated measurement, mean bias was similar. CONCLUSION: The automated NT measurement leads to a further standardization of the NT assessment process. Especially inexperienced operators may benefit from this tool.