European Journal of Cardiovascular Medicine

Ovarian cancer is the eighth most common cancer in women with an incidence of 295 414 cases and a rate of 7.8 per 100,000 women identified in 2018, accounting for 3.4% of female malignant tumors [1]. It contributes to women mortality with a rate of 4.9 per 100, 000.1 This relatively high mortality rate is associated with delayed onset of symptoms and lack of appropriate screening tools which lead to its diagnosis in advanced stages [2].  There are different histological types of ovarian cancer. The epithelial type being the prevailing one [3]. Various risk factors affect the development of ovarian cancer. Age and genetic predisposition are among the most important factors [4]. Despite the progress made in the implementation of accurate staging and therapeutic strategies, the main prognostic factor remains the stage of the disease at the time of diagnosis [2]. There is a crucial need to make an early diagnosis to obtain a real benefit in terms of survival [5]. Several early detection methods for ovarian cancer are being used; however, the most effective screening technique remains controversial [6]. The first studies with trans abdominal pelvic ultrasound have allowed to standardize the morphological ultrasound criteria to make a differential diagnosis between benign and malignant cystic ovarian mass [7].

AIMS and OBJECTIVE:

A Prospective observational study conducted in an out-patient and in patient department of OBG after obtaining institutional ethical committee clearance from the institute, in Madhubani Medical College, Madhubani, Bihar. The study was done for a period of 1 year. Study Period:  September 2023 to August 2024. A pre-designed study pro-forma was filled in relevant investigations and clinical assessments were carried out in all cases.

The prospective observational study and was conducted in patients admitted in Madhubani Medical College and Hospital, Madhubani, Bihar. This was a prospective study conducted in the Madhubani Medical College, Madhubani, Bihar between September 2023 to August 2024. We invited to participate in the study 76 womenwho had been referred to the ovarian pelvic oncology outpatient clinic due to the identification, by clinical and/or imaging examination, of an adnexal tumor. Their referral was in order to evaluate the indication for surgery for diagnosis and/or treatment. After the initial interview, including an explanation about the study’s research methods and purpose, all women included in the study gave written informed consent to participate. The study was approved by the faculty’s research ethics committee. We collected information regarding age, ethnic back ground, current or previous hormonal contraception, menopausal status and family history of breast cancer or ovarian cancer, and measured the body mass index (BMI) (in kg/m2). An ultrasound evaluation was scheduled and peripheral blood was collected for serum measurements of the CA125 tumor marker. These women then underwent surgical intervention and the pathologic specimens were sent for histopathological analysis.

Ultrasound examination

Ultrasound examination Ultrasound evaluations were performed in the Ultrasound Technical Section of UNICAMP, using one of the ultrasound machines available in the section: Accuvix V10 (Medison Corporation Ltd, Seoul, South Korea), Nemio XG (Toshiba Corporation, Tokyo, Japan) and Voluson Expert 730 (GE Healthcare Ultrasound, Milwaukee, WI, USA), all equipped with convex, endocavitary, broadband and high-resolution multifrequency transducers, and all with amplitude spectral Doppler capability. The evaluation was performed by the researcher responsible (C.A.H.), a physician who had been training in ultrasonography techniques for the previous 2 years, supervised by one of the associated researchers (R.M.J.),a physician in the ultrasound section who had 10 years’ experience in the Sonographic evaluation of ovarian tumors, having performed at least 5000 examinations in a referral center. Ultrasound evaluation was performed with the woman in a supine position. Initially we used a transabdominal approach, with the woman’s bladder full; she was then asked to empty her bladder, and we performed a supplementary transvaginal examination. Adnexal masses were described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/unilocular solid/multilocular/multilocular-solid), size in three dimensions (longitudinal, anteroposterior and transverse diameters); volume (calculated electronically by the ultrasound device); intracystic fluid echogenicity; number of locutions; presence and size of septations (only thickest of septations was considered); presence, number and size of solid papillary projections (largest thickness was considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volumeinthe posterior cul-de-sac; and presence and location of lesions suggestive of metastases. We then applied power Doppler and made a subjective, semi-quantitative assessment for the tumor as a whole, allocating a score from 1 to 4 according to the amount of blood flow detected (none, minimal, moderate or intense, respectively). We used nomenclature according to the IOTA Group [7]. Final ultrasound classification based on the criteria of Timmerman et al. [11] was used to group adnexal masses into sonographically malignant or benign lesions depending on which of the 10 ultrasound features was observed. The five malignant features, designated ‘M’, included irregular solid tumor (M1); presence of ascites (M2); presence of at least four papillary projections (M3); irregular multilocular solid tumor with a maximum diameter of 100 mmormore(M4);andhighDopplerflow (color score 4) (M5). The five benign features, designated ‘B’, included unilocular ovarian cyst (B1); presence of solid components smaller than 7 mm in diameter (B2); presence of acoustic shadows (B3); multilocular tumor with smooth walls and maximum diameter measuring less than 100 mm (B4); and no detectable blood flow on Doppler examination (color score 1) (B5). If one or more M features were present in the absence of B features, the tumor was classified as malignant. If one or more B features were present in the absence of M features, the tumor was classified as benign. When both B features and M features were present or none of the features was present, the mass was considered non-classifiable according to these ultrasound criteria. In these cases, the tumor was classified subjectively as benign or malignant by anexperienced examiner (R.M.J.). If the tumor did not present the classic imaging findings related to functional cysts, teratomas, typical endometriomas, hydrosalpinx, peritoneal pseudocyst or fibroids (subjectively benign tumors), lesions were then classified as suspicious and therefore subjectively malignant, regardless of clinical information.

CA125 measurement

Automated analysis of CA125 was performed by solid phase chemiluminescence using the OM-MAtest(Siemens Medical Solutions Diagnostics, Tarrytown, NY, USA) according to the manufacturer’s instructions and using their reagents and equipment. Values were expressed in units per milliliter (U/mL). CA125 values were later dichotomized into positive or negative, according to the cut-off point determined by the receiver–operating characteristics (ROC) curve of this population.

SAMPLES OF THE STUDY- Thestudy was carried out among 76 patients of age 25 years and above attending the Out Patient OBG Department (OPD) connected with Madhubani District of Bihar.

STUDY DURATION:      September 2023 to August 2024 (12 months)

Inclusion criteria:

All subjects with ultrasonographic diagnosis of ovarian tumors were included.

Exclusion criteria

Exclusion criteria Pelvic masses other than ovarian tumors, functional, inflammatory, and metaplastic ovarian cyst were excluded.

STATISTICAL ANALYSIS: Statistical analysis Compiled data was statistically analyses using Chi square test and/or Fischer’s exact test to compare contingency distribution as appropriate and ROC analysis was performed to predict benign and malignant ovarian tumors.

A total of 76 patients were included in the study with 43 patients in group A and 33 patients in group B. There were no significant differences between the two groups in terms of mean age and parity. Of the 43 adnexal masses studied in group A, 8 (19.0%) were malignant, 33 (78.6%) were benign and 1 (2.4%) was borderline. The most common malignant mass was first stage adenocarcinoma (62.5%) whereas the most common benign masses were serosal cysts (30.3%) followed by ovarian endometriosis cyst and cyst adenoma (simple) cysts (21.2% each). On the other hand, of the 32 masses examined in group B, 7 (21.9%) were malignant, 23 (71.9%) were benign and 2 (6.3%) were borderline. First stage adenocarcinoma was the highest among malignant neoplasms (57.1%) while serosal cysts were the highest among benign tumors (39.1%) followed by para-ovarian cysts (17.4%).

The mean morphology scores for group A are shown for the malignant cases, the highest mean scores were for metastasis (13.0) and adenocarcinoma (12.6±0.0). As for the benign cases, the mean score for thecoma and para-ovarian cyst was 6.0±0.0 and for fibroma 4.6±0.0. The characteristics of group B masses in terms of morphology score, as well as resistance index (RI), pulsatility index (PI) and peak systolic velocity (PSV) obtained by color Doppler. The site of vascularization was found to be mainly central in malignant lesions and predominantly peripheral in benign lesions. The absence of flow has been highlighted especially in benign lesions. The average value of the resistance index was 0.4±0.1 for malignant lesions and 0.5±0.04 for benign ones. The mean pulsatility index was 0.9±0.5 for malignant tumors and 1.0±0.2 for benign ones. The mean peak systolic velocity was 17.7±12.7 cm/s for malignant masses and 6.4±0.9 cm/s for benign masses. From the analysis of the results obtained by evaluating only the ultrasound morphological aspect of the masses, it was possible to highlight that this method has a sensitivity of 89.0%, a specificity of 100.0%, a positive predictive value (PPV) of 100.0%, a negative predictive value (NPV) of 97.0% and accuracy of 97.0%.

From the analysis of the results obtained by color Doppler only, it was shown that this method has a sensitivity of 55.6%, a specificity of 95.5%, a PPV of 83.0%, a NPV of 84.0% and accuracy of 84.0%. When combining color Doppler to ultrasound morphology score, the sensitivity was 100.0%, specificity 95.5%, PPV 90.0%, NPV 100.0% and accuracy 96.6%.

Fig: 1-Sonographic assessment of complex                     Fig: 2 Dopler ultrasound

Ultrasound morphology adnexal tumours.

Fig: 3 Benign Ovarian mass

The present study showed that the use of color Doppler in addition to ultrasonography and ultrasound morphological study yields better characterization of ovarian masses and improve the diagnosis of malignant and benign tumors as well. Despite the numerous therapeutic protocols implemented in several studies; yet, ovarian cancer remains one of the most common cause of death among women [3]. This is attributed to two unfavorable events. On one hand, ovarian cancer does not show symptoms in the early stage; hence, the diagnosis in most cases is made late. On the other hand, the treatments implemented are less effective in the advanced stages [2]. Consequently, the only effective approach to this pathology remains the identification of the disease in the initial stages since survival rate would increase up to 70% [3]. Both transabdominal and transvaginal pelvic ultrasonography are instrumental techniques widely used in ascertaining female neoplasms to identify the size and morphology of adnexal masses [9,14]. They allow to evaluate some morphological parameters of the masses such as volume, wall thickness, their structure and possible presence of vegetation, possible presence of septa and their thickness, as well as echogenicity and content [7,11]. However, it is evident that this method is not able, on the basis of the morphological characteristics alone, to distinguish between benign and malignant tumors, especially in early stages [11]. It has been reported that the sensitivity of morphologic analysis with ultrasound in predicting malignancy in pelvic tumors ranged between 87% and 100% whereas the specificity ranged between 45% and 95% [11,14-16]. In this study, the sensitivity of this technique was 89.0% while the specificity was 100.0%.

In our experience, differentiating between benign and malignant pathology on the basis of the morphological evaluation alone, even if standardized with a score, or of the Doppler evaluation alone is not always satisfactory. We believe that the ultrasound study of pelvic masses with the combination of color Doppler and morphological study improves the diagnosis of pelvic tumors.

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