Lesion size affects diagnostic performance of IOTA logistic regression models, IOTA simple rules and risk of malignancy index in discriminating between benign and malignant adnexal masses.

OBJECTIVES: To estimate the ability to discriminate between benign and malignant adnexal masses of different size using: subjective assessment, two International Ovarian Tumor Analysis (IOTA) logistic regression models (LR1 and LR2), the IOTA simple rules and the risk of malignancy index (RMI). METHODS: We used a multicenter IOTA database of 2445 patients with at least one adnexal mass, i.e. the database previously used to prospectively validate the diagnostic performance of LR1 and LR2. The masses were categorized into three subgroups according to their largest diameter: small tumors (diameter < 4 cm; n = 396), medium-sized tumors (diameter, 4-9.9 cm; n = 1457) and large tumors (diameter ≥ 10 cm, n = 592). Subjective assessment, LR1 and LR2, IOTA simple rules and the RMI were applied to each of the three groups. Sensitivity, specificity, positive and negative likelihood ratio (LR+, LR-), diagnostic odds ratio (DOR) and area under the receiver-operating characteristics curve (AUC) were used to describe diagnostic performance. A moving window technique was applied to estimate the effect of tumor size as a continuous variable on the AUC. The reference standard was the histological diagnosis of the surgically removed adnexal mass. RESULTS: The frequency of invasive malignancy was 10% in small tumors, 19% in medium-sized tumors and 40% in large tumors; 11% of the large tumors were borderline tumors vs 3% and 4%, respectively, of the small and medium-sized tumors. The type of benign histology also differed among the three subgroups. For all methods, sensitivity with regard to malignancy was lowest in small tumors (56-84% vs 67-93% in medium-sized tumors and 74-95% in large tumors) while specificity was lowest in large tumors (60-87%vs 83-95% in medium-sized tumors and 83-96% in small tumors ). The DOR and the AUC value were highest in medium-sized tumors and the AUC was largest in tumors with a largest diameter of 7-11 cm. CONCLUSION: Tumor size affects the performance of subjective assessment, LR1 and LR2, the IOTA simple rules and the RMI in discriminating correctly between benign and malignant adnexal masses. The likely explanation, at least in part, is the difference in histology among tumors of different size.

Fertility after ectopic pregnancy. Effects of surgery and expectant management.

OBJECTIVE: To evaluate the effects of different management strategies for ectopic pregnancy on fertility. STUDY DESIGN: Retrospective cohort study of 180 consecutive patients who were diagnosed with ectopic pregnancy between September 1988 and December 1995. The fertility rate after ectopic pregnancy treated with surgery was compared with that after expectant treatment. Statistical analysis took into consideration the following confounding variables: history of sterility, infertility, ectopic pregnancy, use of intrauterine device, endometriosis, pelvic inflammatory disease or pelvic surgery prior to ectopic pregnancy, and type of therapy for ectopic pregnancy. RESULTS: Of the 180 women enrolled in the study, 97 desired conception. The intrauterine conception rate was similar in those initially treated expectantly as in those allocated to primary surgery (63% [31/49] vs. 51% [19/37], P = .37). Successful completion of expectant management was associated with rates of subsequent intrauterine pregnancy similar to those of surgical treatment (including primary surgery and surgery after failure of expectant management) (65% [22/34] vs. 54% [28/52], P = .44). Women undergoing delayed surgery due to failure of expectant management had rates of subsequent intrauterine conception similar to those who underwent primary surgery (9/15 vs. 19/37, P = .79). Several anamnestic factors had a significant and adverse effect on reproductive outcome: history of infertility (P = .01), history of ectopic pregnancy (P = .02) and previous pelvic surgery (P = .001). CONCLUSION: Expectant and surgical management of ectopic pregnancy had similar subsequent intrauterine conception rates, even when failure of expectant management led to secondary surgery. Gynecologic history can identify the subgroup of patients at higher risk of a poor reproductive outcome.

Role of puncture and aspiration in expectant management of simple ovarian cysts: a randomised study.

OBJECTIVES: To assess the potential of expectant management for simple ovarian cysts diagnosed by transabdominal or transvaginal ultrasonography. To compare the results of needle aspiration with those achieved with simple observation. DESIGN: Randomised trial. SETTING: Hospital department of obstetrics and gynaecology. SUBJECTS: 278 women with simple cysts randomly allocated to simple observation (143) or ultrasound guided fine needle aspiration (135) between 1990 and 1994. MAIN OUTCOME MEASURES: Resolution of cyst or development of malignancy. RESULTS: After six months 269 were available for follow up. The rate of resolution was 46% (59/128) with aspiration and 44.6% (63/141) with observation. Only the diameter of the cyst (P < 0.0001) was a significant independent prognostic factor for resolution in a multivariate analysis. Age and treatment had no significant effect. One woman was subsequently found to have borderline malignant changes on histopathological examination. Her cyst was detected by transabdominal ultrasonography. CONCLUSIONS: Expectant management for up to six months does not cause risks for the patients and allows spontaneous resolution in over a third of cases, avoiding the costs and risks of unnecessary surgery. Aspiration does not provide better results than simple observation.

Sonographic endometrial thickness: a useful test to predict atrophy in patients with postmenopausal bleeding. An Italian multicenter study.

Eighteen centers took part in this prospective study into which 930 eligible patients were recruited. The selection criteria for admission were atypical bleeding after at least 6 months of postmenopausal amenorrhea, and absence of hormonal therapies for at least 6 months. The sonographic measurement of the maximum bi-endometrial thickness was made in a longitudinal plane. Sonographic measurements were always performed within 3 days prior to histological evaluation. In these patients the mean number of years from menopause (25-75th centile) was 6 (range 2-16). The prevalence of endometrial carcinoma was 11.5% and the prevalence of atrophy was 49.2%. The area under the receiver operator characteristic curves generated by sonographic thickness measurements reached the level of 85%, both for cancer and atrophy. The likelihood ratio for cancer, yielded by an endometrial thickness of < or = 4.0 mm, was 0.05, and for atrophy it was 7.1. This cut-off of > 4.0 mm yielded a sensitivity for the detection of cancer of 98% and a negative predictive value of 99%. The overall sensitivity and positive predictive value for atrophy achieved by this cut-off were 57.2% and 87.3%, respectively. A multivariate logistic model showed that age and body mass index were independent variables associated with a significantly higher risk of endometrial cancer. The post-test probabilities for cancer and atrophy were recalculated on the basis of the integration of age, body mass index and endometrial thickness. The estimated reduction of invasive procedures on the basis of this integration was 31%. Transvaginal sonographic measurement of endometrial thickness, integrated with individual risk factors, can help in the management of postmenopausal patients with atypical bleeding, with regard to either the need for histological evaluation in high risk cases, or the choice of possible expectant management. We have shown that an endometrial thickness of < or = 4.0 mm safely predicts endometrial atrophy and justifies expectant management when the patient understands the need for proper follow up. This could be achieved with a reduction in the use of invasive procedures without unwanted delay in cancer diagnosis.

Safety of transvaginal fine needle puncture of gynecologic masses: a report after 500 consecutive procedures.

Transvaginal sonographically guided puncture may be used for diagnostic and therapeutic purpose in general gynecology and in oncology. To define the complication rate of this technique, 500 consecutive procedures were reviewed; 289 procedures were on cystic masses, 146 on solid tumors, 34 on mixed tumors, and 31 on other lesions. No life-threatening complications occurred. Early mild and self-limited complications developed in eight procedures (1.6%). Short-term complications occurred in four cases (0.8%; two infections, one pelvic pain, one hemorrhage); two of these required surgery. Transvaginal sonographically guided puncture is safe and does not entail a higher risk of infection than transabdominal punctures.

Ultrasound-guided aspiration of endometriomas: possible applications and limitations.

OBJECTIVES: To evaluate the role of needle aspiration in the management of endometriomas. DESIGN: Retrospective evaluation of the activity of the section of interventional ultrasound in a single tertiary care institution. SETTING: Department of Obstetrics and Gynecology, Ospedale S. Gerardo, Monza, University of Milan, Italy. PATIENTS: Two hundred nine premenopausal patients underwent aspiration for diagnostic purpose (n = 166), for relief of symptoms (n = 25), or with therapeutic intent (n = 18). RESULTS: Adequate material was obtained by all punctures. Early complications (self-limiting vagal symptoms or pain) occurred in eight cases. Short-term complications consisted of acute abdominal pain in three cases and infection in one. Three women required surgical treatment of the complication. At first examination after aspiration, persistence of the cyst was observed in all but four cases, including all cases who had undergone therapeutic aspiration. Nine patients reported relief of symptoms but six other patients referred onset or worsening of pelvic discomfort after aspiration. CONCLUSIONS: Ultrasound-guided aspiration of endometriomas is feasible. The transvaginal route reduces early complication but implies a risk of infection of 1.3%. However, drainage alone is ineffective as a therapeutic procedure and the applications of aspiration of endometriomas appear limited to some cases with diagnostic intent.

Prognostic factors for successful expectant management of ectopic pregnancy.

OBJECTIVE: To determine the independent ability of initial hCG titers, trend of hCG titers, and ultrasonographic findings in the prediction of successful expectant management in ectopic pregnancy (EP). DESIGN: Case-control study. SETTING: University hospital. PATIENTS: Sixty-seven patients with EP managed expectantly, 49 of whom (73%) had a spontaneous resolution, whereas 3 (5%) underwent medical treatment, and 15 (22%) eventually underwent surgical treatment. RESULTS: Univariate analysis showed that the initial hCG titer, the trend in hCG titers between first and second sample, and ultrasonographic visualization of absence of an ectopic gestational sac were significant predictors of a successful expectant management. Using receiver operating characteristic curve analysis, an hCG titer < 1,000 mIU/mL was chosen as the optimal cutoff for this prediction, identifying 88% of women destined to have spontaneous resolution of the EP. Multivariate analysis showed that both initial hCG titer and trend in hCG titers but not ultrasonographic visualization of an ectopic gestational sac were independent predictors of a successful or failed expectant management. CONCLUSION: Expectant management of EP is successful in the majority of patients with initial hCG titer < 1,000 mIU/mL.

Prospective multicenter study on the clinical utility of ca-72.4 in postmenopausal patients with pelvic mass.

The study objective was to evaluate the sensitivity and specificity as well as the positive predictive value and negative predictive value of CA 72.4 and CA 125 determination, separately and in combination, for diagnosing ovarian tumors in post-menopausal women with pelvic mass. The 299 patients recruited in this study underwent gynecological examination, plasma determination of CA 72.4 and CA 125, and laparotomy with histological definition of pelvic mass. CA 72.4 assay values were under 3.9 U/ml in 194 cases (70.8%); values ranged from 3.9 to 4.5 U/ml in 7 cases (2.5%) and were greater than 4.5 U/ml in 73 cases (26.6%). CA 72.4 assay was positive (>4.5 U/ml) in 56 cases (57.1%) of malignant ovarian pathology, in 4 cases (25%) of malignant extra-ovarian pathology as well as in 9 cases (7.1%) of benign ovarian pathology and in 4 cases (11.8%) of benign extra-ovarian pathology. With a cut-off at 3.9 U/ml, CA 72.4 showed a specificity of 91.3% and a sensitivity of 62.2%, whereas with a cut-off at 4.5 U/ml specificity was 92.9% and sensitivity 57.1%. Results of CA 125 assay for diagnosing a pelvic neoplasia (ovarian or extra-ovarian), showed a specificity of 85.3% and sensitivity of 68.8%. The agreement of the two markers (CA 125 and CA 72.4) as negative or positive shows a specificity of 77% and a sensitivity of 84.7% for ovarian cancer and a specificity of 73.5% and sensitivity of 75% for the diagnosis of pelvic neoplasias.

Prospective multicenter study on CA 125 in postmenopausal pelvic masses.

The purpose of this study was to determine the diagnostic value of CA 125 in comparison with transabdominal ultrasound (US) in the evaluation of postmenopausal women with pelvic mass to detect malignant epithelial ovarian tumors. Postmenopausal patients with pelvic mass were studied with gynecologic examination, US and CA 125 determination. Three hundred eighty-eight patients were entered in the study. According to stratification based on US (probably benign, equivocal, possibly malignant) and CA 125 (< 35 U/ml, negative; between 35 and 65 U/ml, borderline; > 65 U/ml, positive), 290 patients were considered eligible for surgery. Specificity, sensitivity, positive and negative predictive value, and accuracy of US and CA 125 were calculated with respect to histological examination. Out of 290 operated patients, 134 had a benign ovarian pathology, 34 had extraovarian benign pathology, 106 had an ovarian malignancy, and 16 presented with an extraovarian malignant pathology. The results according to ovarian malignant pathology were as follows. CA 125 (> 65 U/ml): Specificity, 92.5%; sensitivity, 71.7%; accuracy, 83.3%. CA 125 (> 35 U/ml): Specificity, 82.0%; sensitivity, 78.3%; accuracy, 80.4%. US: Specificity, 77.6%; sensitivity, 84.9%; accuracy, 80.3%. Combination of US and CA 125 (> 65 U/ml): Specificity, 96.1%; sensitivity, 91.7%; accuracy, 94.3%. Determination of CA 125 is a highly specific method in predicting ovarian cancer in postmenopausal women with a pelvic mass. The association with US significantly improves the overall accuracy and may support therapeutical decision making by distinguishing between a significant percentage of women most likely to benefit from prompt intervention and women who may be managed following minor surgical diagnostic approach, such as fine-needle aspiration.

Transvaginal ultrasound-guided fine needle sampling of deep cancer recurrences in the pelvis: usefulness and limitations.

The usefulness of fine needle sampling (FNS) under transvaginal ultrasound guidance in gynecologic oncology patients is evaluated in this study. Between 1990 and 1993, 101 FNS under transvaginal ultrasound guidance were performed in 88 sessions. All targets were located deep in the pelvis and their median diameter was 30 mm. All procedures were performed on an outpatient basis. Sampling consisted of 46 cytologic aspirates and 55 biopsies. No false-positive result was obtained when cytologic results were correlated with both clinical outcome and surgical biopsy. For aspirates and biopsies, sensitivity was respectively 76 and 91%, while accuracy was 83 and 91%. Inadequate results were recorded in 11 aspirates and in 9 biopsies. In 7 of 12 sessions where both aspiration and biopsy were performed, false-negative or inadequate cytologic result was overcome by true-positive biopsies. No moderate or severe complication was observed. FNS under transvaginal ultrasound guidance is a safe procedure with limited invasiveness and extremely high specificity even when performed on small targets. Whenever possible, biopsies should be preferred. A negative FNS obtained from a clinically suspicious lesion requires a repeat sampling.

Ultrasound in the follow-up of young patients with malignant ovarian tumors after conservative surgery.

Ultrasound examinations were performed us a step in the follow-up of 62 patients previously treated with conservative surgery for malignant ovarian tumors. With a minimal follow-up period of 36 months (range 36-129) 12 recurrences of disease were observed in nine patients. When compared to other routine follow-up procedures, ultrasound examination proved to be the most effective procedure in the monitoring of these patients, correctly detecting ten recurrences. Physical and gynecological examinations detected seven, tumor marker measurements detected six and chest X-rays detected one. Ultrasound examination was 83% sensitive, 99% specific and 99% accurate in the detection of recurrent disease. In four recurrences leading to death, the diameters of the tumors at first detection were 25, 50, 50 and 100 mm, significantly higher (p = 0.03) than in seven recurrences followed by complete response of the tumor (range 15-35 mm, median 30 mm). Ultrasound appears to be superior to physical and gynecological examination in early detection of recurrence; considering that smaller burdens of tumor at the time of recurrence seem to imply a better prognosis, ultrasound should be considered us a useful additional procedure in the follow-up of these patients.

Early and short-term complications after US-guided puncture of gynecologic lesions: evaluation after 1,000 consecutive cases.

PURPOSE: To ascertain the complication rate associated with ultrasound (US)-guided puncture of gynecologic lesions. MATERIALS AND METHODS: Between 1986 and 1992, 878 transabdominal and 122 transvaginal US-guided punctures of gynecologic lesions were performed in 893 patients. Most of the procedures were performed in adnexal cysts (n = 838); the rest, in solid tumors (n = 66), mixed tumors (n = 56), or lymphoceles, abscesses, or fluid collections (n = 40). No anesthesia or antibiotic prophylaxis was routinely used. RESULTS: No life-threatening complication was recorded. Early complications (defined as complications that occurred within 24 hours after puncture) were recorded in 31 patients and consisted mainly of transient vagal symptoms or pain. Short-term complications (within 5 days after puncture) were recorded in 10 patients, six of whom required surgery. CONCLUSION: US-guided puncture of gynecologic lesions is safe in selected patients. Complication rates depend on the type of lesion and are very high in dermoid cysts, which should not be punctured, and extremely low in serous cysts, solid tumors, and mixed tumors.

[Intrahepatic cholestasis in pregnancy: incidence, clinical course, complications]. / Colestasi intraepatica gravidica: incidenza, decorso, complicanze.

From January 1st, 1984 to December 31st, 1988 67 cases of cholestasis during pregnancy (frequency rate 0.7%) have been reviewed. In the 79% of the cases cholestasis arose after the 32nd week. Preterm deliveries were 19.5% and cesarean sections were 19.4%. Perinatal mortality was 30%. Pregnancy complicated by cholestasis is a high risk problem in obstetrics. An attempt to show a clinical management is exposed.