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Accuracy of Ultrasound Imaging Findings in Diagnosis of Adnexal Masses: A Cross-sectional Study |
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Harish Gambhir, Kewal Aditya, Ravinder Pal Singh, Subhash Singla, Roma Issacs, Sunita Goyal 1. Assistant Professor, Department of Radiodiagnosis, Christian Medical College and Hospital, Ludhiana, Punjab, India. 2. Senior Resident, Department of Radiodiagnosis, Christian Medical College and Hospital, Ludhiana, Punjab, India. 3. Postgraduate Resident, Department of Radiodiagnosis, Christian Medical College and Hospital, Ludhiana, Punjab, India. 4. Professor, Department of Radiodiagnosis, Christian Medical College and Hospital, Ludhiana, Punjab, India. 5. Professor, Department of Pathology, Christian Medical College and Hospital, Ludhiana, Punjab, India. 6. Professor, Department of Obstetrics and Gynaecology, Christian Medical College and Hospital, Ludhiana, Punjab, India. |
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Correspondence Address : Dr. Ravinder Pal Singh, Postgraduate Resident, Department of Radiodiagnosis, Christian Medical College and Hospital, Ludhiana, Punjab, India. E-mail: docravi81@gmail.com |
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ABSTRACT | ||||||||||||||||||||||||||||||||||||||||
: Introduction: Adnexal mass lesions are common among women of all age groups. Precise preoperative estimation of the benign or malignant nature of an adnexal mass is important to avoid additional surgical treatment. Sonography is the initial imaging study of choice in the evaluation of women with suspected adnexal masses. Assiut scoring model is a simpler model for differentiation of adnexal masses into benign and malignant using various ultrasonographic parameters. Aim: To assess the accuracy of ultrasound in differentiating benign from malignant adnexal masses using Assiut Scoring Model. Materials and Methods: This cross-sectional study was conducted in Department of Radiodiagnosis at Christian Medical College and Hospital (tertiary care hospital), Ludhiana, Punjab, India, from November 2018 to January 2021. The study included 80 cases of adnexal masses. An Ultrasound (USG) diagnosis was made based on tumour volume, type of mass, papillary projections, septae and vessel location and Assiut score was obtained. Histopathological examination was carried out following surgery or biopsy. The diagnostic accuracy of USG (with histopathology as gold standard) was determined. Sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of USG was assessed for predicting malignancy taking histopathology as gold standard. The p-value <0.05 was considered statistically significant. Results: Most numbers of patients 33 (41.2%) belonged to age group 21-30 years. Mean age of study subjects was 35.35±12.8 years. Majority 60 (75%) of patients were benign and 20 (25%) were malignant. The USG findings showed good agreement with histopathology (kappa=0.76, p-value <0.0001). Sensitivity, specificity, PPV and NPV for correctly predicting malignant lesions being 90%, 90%, 75% and 96.43% respectively. Median Assiut score in malignant was significantly higher as compared to benign (9.95 vs 3.47, p-value <0.0001). Characteristics such as central or septal vascularisation, presence of thick septa, papillary projections, multilocularity and high tumour volume (especially above 500 mL) showed a significant association with malignancy (p-value <0.0001). Conclusion: The USG based Assuit scoring model is a good tool in differentiating benign from malignant adnexal masses with high sensitivity and specificity. | ||||||||||||||||||||||||||||||||||||||||
Keywords : Adnexal masses, Assiut score, Diagnostic accuracy, Ultrasonography | ||||||||||||||||||||||||||||||||||||||||
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DOI and Others :
DOI: 10.7860/IJARS/2023/53616.2884
Date of Submission: Dec 24, 2021 Date of Peer Review: Jan 22, 2022 Date of Acceptance: Jul 25, 2022 Date of Publishing: May 01, 2023 AUTHOR DECLARATION: • Financial or Other Competing Interests: None • Was Ethics Committee Approval obtained for this study? Yes • Was informed consent obtained from the subjects involved in the study? Yes • For any images presented appropriate consent has been obtained from the subjects. Yes PLAGIARISM CHECKING METHODS: • Plagiarism X-checker: Dec 27, 2021 • Manual Googling: Jul 22, 2022 • iThenticate Software: Jul 24, 2022 (12%) ETYMOLOGY: Author Origin |
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INTRODUCTION | ||||||||||||||||||||||||||||||||||||||||
Adnexal mass lesions are fairly common among women (the prevalence of 0.17-5.9% among asymptomatic women and 7.1-12% among symptomatic women) of all age group but very common among reproductive age (1). The reported prevalence varies widely depending upon the type of study population as well as the inclusion criteria. A recent study conducted in India reported the prevalence of adnexal lesion to be 16% (2). The most commonly encountered symptoms found in patients with adnexal mass include abdominal fullness/bloating, pelvic pain, difficulty in bowel movements, increased frequency of urination, abnormal vaginal bleeding or pelvic pressure (3). The presence of adnexal mass is one of the leading indications for gynecological surgery. Adnexal masses can be benign or malignant. The number of suspected benign masses is far greater than the number of malignant masses (4). Sonography is the initial imaging study of choice in the evaluation of women with suspected adenaxal masses. Assiut Scoring Model is the simpler model for differentiation of adenaxal masses into benign and malignant using various ultrasonographic parameters (5). The advantage of this scoring model is the objectivity with which data has to be collected and processed to give us a score. The score is then used to categorise masses into benign or malignant. There are no studies in India that assess the accuracy of ultrasound as imaging modality in differentiating benign from malignant lesions using Assiut scoring model. Hence, the present study was conducted with the aim to assess the accuracy of ultrasound as imaging modality in differentiating benign from malignant lesions using Assiut scoring model and concordance with histopathology. | ||||||||||||||||||||||||||||||||||||||||
Material and Methods | ||||||||||||||||||||||||||||||||||||||||
This cross-sectional study was conducted in Gynaecology ultrasound wing of the Department of Radiodiagnosis at Christian Medical College and Hospital (tertiary care hospital), Ludhiana, Punjab, India, from November 2018 to January 2021. Institutional Ethics Committee approval was taken (Ref: 201812624/IECCMCL/PG Thesis- radio diagnosis). Informed consent was taken from all the patients. Sample size calculation: The sample size was calculated using formula: N=DEFF×Np(1-p)/{d2/z2 (N-1)+p(1-p) where, DEFF=Design effect, Z value=1.96 for p=0.05 or 95% confidence intervals, P=Estimated prevalence, d=Desired precision (for example, 0.05 for ±5%) Using OpenEpi online calculator (https://www.openepi.com/Samplesize/SSPropor.htm). The population size was 360 (number of adnexal mass patient diagnosed on sonography in a year) and anti fre is 12% at 90% confidence interval. Inclusion criteria: Clinically suspected cases of adnexal masses confirmed by ultrasonography and operated at Christian Medical College and Hospital, Ludhiana, India, without any age range were included in the study. Exclusion criteria: All midline uterine masses and pelvic masses unlikely to be adnexal were excluded from the study. Study Procedure Ultrasonography (USG): Ultrasound examination was done on all the patients included in the study on HDX-11E (Phillips Medical Systems) with a 3.5 MHz convex transducer. The patient was examined with full bladder. The coupling agent was applied liberally on patient’s skin to act as an acoustic window removing the air between the transducer and patient’s skin surface and swift movement of the transducer was allowed. To evaluate the adnexal mass, an ultrasound examination consisting of either transabdominal or transvaginal sonography with colour doppler for suspicious cases of malignancy was done. Sonographic findings regarding tumour volume, type of mass, papillary projections, septae and vessel location were assessed. The findings of sonography were recorded and provisional diagnosis was made. Assiut scoring model: The Assiut score for assessing the malignant nature of the adnexal lesions. It is based on various malignant features where the characteristics are rated on a score of 0-3 and the total score of ≥6 indicates malignancy (Table/Fig 1) (5). Histopathology: The histopathological reports of the patients undergoing surgery were obtained from the Department of Pathology, Christian Medical College and Hospital, Ludhiana, India. The results were classified into malignant or benign mass. Outcome measures: • The primary outcome measure was diagnostic accuracy of USG against histopathology as gold standard. • The secondary outcome measures were association of USG characteristics such as tumour volume, type of mass, papillary projections, septae, colour score with histopathology finding. Statistical Analysis The data analysis was done using the Statistical Package for Social Sciences (SPSS) software version 21.0. The demonstration of the categorical variables was in the form of number and percentage while the presentation of the continuous variables was done as mean±Standard Deviation (Mean±SD) and median values. Kolmogorov-Smirnov test was used to check normality. Mann-Whitney test (for not normally distributed data) and Independent t-test (for normally distributed data) and Fisher’s exact test was used. Inter-rater kappa agreement was used to find out the strength of agreement between USG and histopathology. Sensitivity, specificity, PPV and NPV of USG was assessed for predicting malignancy taking histopathology as gold standard. For statistical significance, p-value <0.05 was considered as significant. | ||||||||||||||||||||||||||||||||||||||||
Results | ||||||||||||||||||||||||||||||||||||||||
In present study, most numbers of patients 33 (41.2%) belonged to age group 21-30 years. Mean age of study subjects was 35.35±12.8 years with median (25th-75th percentile) of 32 (26.5-41.5) (Table/Fig 2). In majority (43.75%) of patients, type of mass was unilocular (Table/Fig 3). In majority of patients, 50 (62.5%) tumour volume was 0-50 mL (Table/Fig 4). Characteristics such as central or septal vascularisation, presence of thick septa, papillary projections, multiocularity and high tumour volume (especially above 500 mL) showed a significant association with malignancy (p-value <0.0001) [Table/Fig-4-8]. The (Table/Fig 9) shows association of total score with histopathology findings. Proportion of histopathology finding (benign) was significantly higher in benign by USG as compared to malignant by USG (96.43% vs 3.57% respectively) and histopathology finding (malignant) was significantly higher in malignant by USG as compared to benign by USG (25% vs 75% respectively) (p-value <0.0001) (Table/Fig 10). Good agreement exist between histopathology and USG with kappa 0.750 and p-value <0.0001. Among 60 patients diagnosed as benign by histopathology, 54 patients had similar findings in USG. Among 20 patients diagnosed as malignant by histopathology, 18 patients had similar findings in USG (Table/Fig 11). Sensitivity, specificity, PPV and NPV of USG for correctly predicting malignant lesions being 90%, 90%, 75% and 96.43% respectively (Table/Fig 12). Ultrasonographic findings are seen in (Table/Fig 13),(Table/Fig 14),(Table/Fig 15),(Table/Fig 16),(Table/Fig 17),(Table/Fig 18). | ||||||||||||||||||||||||||||||||||||||||
Discussion | ||||||||||||||||||||||||||||||||||||||||
The present study was a cross-sectional study on 80 women with adnexal masses who were investigated with an aim to determine the utility of USG in differentiating benign from malignant masses using Assuit Scoring Model. There is currently no study done in India which uses this scoring method. The results of this study can be used to compare the utility of this scoring model as compared to other methods in Indian context. Sharma A et al., found that USG diagnosis of adnexal masses revealed a sensitivity of 94.4% specificity of 83.3%, PPV of 70.8%, and NPV of 97.2% (6). In a study by Prasad BS and Shetty M, USG showed the sensitivity of 92%, specificity of 89% in differentiating benign from malignant lesions (7). Priya FM and Kirubamani VN, showed USG sensitivity of 88% and specificity of 80.68% in prediction of ovarian cancer (8). Radhamani S and Akhila MV, revealed that USG had sensitivity of 87.5% and specificity of 95.65% with an accuracy of 95% for predicting ovarian cancer (9). In a study by Rathore OP et al., USG showed sensitivity of 100%, specificity of 88.4% and accuracy of 90.3% in diagnosing malignancy in adnexal masses (10). Sarbhai V et al., reported that sensitivity of USG in diagnosing simple ovarian cyst was 20% with NPV of 80% (11). USG has low sensitivity in diagnosing endometrioma of 50% and high specificity of 94.1% with PPV of 75% and NPV of 84.2%. A comparative analysis of diagnostic accuracy for USG in our study and other studies has been shown in the (Table/Fig 19) (6),(7),(8),(9),(10),(12). The present study results found that USG findings showed good agreement with histopathology (kappa=0.750, p-value <0.0001). Overall, USG showed a good diagnostic accuracy in predicting the malignant nature of the adnexal lesion before surgery, thus guiding us to an appropriate management. The strength of the study was that, many of present results corroborated with other studies done at different times and in different places both in India as well as outside India. This study, thus, adds to the already existing literature about the concordance of diagnosis made from USG and histopathology with one another and analysed the reliability of USG in reaching a correct diagnosis in Indian women with adnexal masses. Thus, the current study can act as a stepping stone for further larger studies to find out accuracy of USG using Assiut Scoring Model in Indian women with adnexal masses. Limitation(s) Although, the sample size of the study was good, but being a single centre hospital based study, the results of the concordance of USG and histopathology in reaching a correct diagnosis in women with adnexal masses may need further validation. Another limitation was that USG was not compared with other diagnostic modalities such as Magnetic Resonance Imaging (MRI), which would have been valuable in understanding advantages of USG above other diagnostic modalities. Being a cross-sectional study, the treatment and outcomes of the women were not analysed. | ||||||||||||||||||||||||||||||||||||||||
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Original article / research
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