FIELD OF THE INVENTION
[001] The present invention relates to the field of medical science, and more particularly, the present invention relates to a triple-phase multidetector computed tomography of hepatic masses with cytopathological correlation.

BACKGROUND FOR THE INVENTION:
[002] The following discussion of the background to the invention is intended to facilitate an understanding of the present invention. However, it should be appreciated that the discussion is not an acknowledgment or admission that any of the material referred to is published, known, or part of the common general knowledge in any jurisdiction as of the priority date of the application. The details provided herein the background if belongs to any publication is taken only as a reference for describing the problems, in general terminologies or principles or both of science and technology in the associated prior art.
[003] Liver is an important constituent of the digestive tract to maintain the body’s metabolic homeostasis. Due to its major function of detoxification of the body and its rich blood supply by the hepatic artery and portal vein, it becomes prone to various diseases. Liver cancer is the sixth most common type of cancer in terms of incidence and third in terms of cancer related mortality worldwide. The accurate and reliable determination of the nature of the liver mass is important to ensure that malignant lesions are diagnosed correctly. USG is an imaging technique that can provide anatomical and functional images with high resolution. Emphasis has shifted to more advanced and more precise imaging techniques such as Computed Tomography (CT) and Magnetic Resonance Imaging (MRI). Multi-slice (multidetector-row) CT (MDCT) has a four-row configuration of detectors, sub-second gantry rotation time, and overcomes the limitations of single-slice CT scanners, especially in terms of scanning time and limited z-axis resolution. One of the advantages of computed tomography is that it outperforms USG and MRI for evaluating the extra-hepatic abdomen.
[004] In light of the foregoing, there is a need to conduct a study for a triple-phase multidetector computed tomography of hepatic masses with a cytopathological correlationthat overcomes problems prevalent in the prior art.

OBJECTS OF THE INVENTION:
[005] Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows.
[006] The principal object of the present invention is to overcome the disadvantages of the prior art by providing a triple-phase multidetector computed tomography of hepatic masses with a cytopathological correlation.
[007] An object of the present invention is to provide a triple-phase multidetector computed tomography of hepatic masses with a cytopathological correlation, wherein the study evaluates triphasic MDCT in the characterization of hepatic masses and correlates with histopathological/cytopathological diagnosis.
[008] Another object of the present invention is to provide a triple-phase multidetector computed tomography of hepatic masses with a cytopathological correlation, wherein the study characterizes various hepatic masses with the help of a triple-phase MDCT scan.
[009] Yet another object of the present invention is to provide a triple-phase multidetector computed tomography of hepatic masses with a cytopathological correlation, wherein the study correlates with histopathological/cytopathological findings.
[010] Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

SUMMARY OF THE INVENTION:
[011] The present invention provides a triple-phase multidetector computed tomography of hepatic masses with cytopathological correlation.
[012] According to one aspect of our invention, by convenient sampling, in this observational study, 55 patients with a primary diagnosis of hepatic masses on the basis of USG, are recruited and their triphasic MDCT scan findings are evaluated and later correlated with histopathology.
[013] In another aspect of the invention, SPSS version 22 and electronic Microsoft Excel spreadsheets are used. Categorical data has been represented as frequency (number) and proportions (percentages), and continuous data as Mean±Standard Deviation (SD).
[014] In another aspect of the invention, ANOVA and Chi-square tests are used.
In another aspect of the invention, an agreement between different diagnostic modalities is made using Kappa-statistic.
In another aspect of the invention, the confidence level is kept at 95%, hence ap-value <0.05 is considered statistically significant.
[015] Among 55 patients, 4 (7.27%) are benign and 51 (92.73%) are malignant cases detected with the help of USG, and the same is verified on the basis of triphasic CT assessment.
[016] On histopathology, 50 (90.91%) are identified as malignant lesions while 5 (9.09%) cases are diagnosed as benign lesions.
[017] Thus, a triphasic CT scan has a sensitivity of 100%, specificity of 80%, positive Predictive Value (PPV) of 98.04%, Negative Predictive Value (NPV) of 100%, and diagnostic accuracy of 98.18% in differentiating benign liver lesions from malignant liver lesions.
[018] In another aspect of the invention, Early and accurate diagnosis of liver lesions is the foremost requirement in treatment.
[019] In another aspect of the invention, a triple-phase MDCT scan along with USG can solve this and recommend in every suspected hepatic mass.

BRIEF DESCRIPTION OF DRAWINGS:
[020] Reference will be made to embodiments of the invention, examples of which may be illustrated in accompanying figures. These figures are intended to be illustrative, not limiting. Although the invention is generally described in the context of these embodiments, it should be understood that it is not intended to limit the scope of the invention to these particular embodiments.
[021] Table/Figure 1 shows a demographic profile of cases enrolled in study in accordance with the present invention.
[022] Table/Figure 2 shows presenting sign and symptoms in accordance with the present invention.
[023] Table/Figure 3 shows a) NCCT showing solitary hypodense lesion in the right lobe of the liver;b,c,d) CECT arterial, venous or delayed phase images showing no significant enhancement suggesting benign neoplasm (Adenoma) in accordance with the present invention.
[024] Table/Figure 4 shows a) NCCT showing solitary hypodense lesion in the right lobe of the liver;b,c,d) CECT shows heterogenous enhancement on arterial phase and rapidishout on portal venous and delayed phase images suggesting Malignantneoplasm (Hepatocellular carcinoma) in accordance with the present invention.
[025] Table/Figure 5 shows a Triphasic CT diagnosis of liver lesions in accordance with the present invention.
[026] Table/Figure 6 shows the Haematoxylin and Eosinstained tissue section (100x magnification) showing metastatic deposits of moderately differentiated carcinoma arranged in an acinar pattern in accordance with the present invention.
[027] Table/Figure 7 shows the Correlation between MDCT and Histocytopathological findings.?=0.962; p<0.001 (Kappa-test for agreement) in accordance with the present invention.
[028] Table/Figure 8 shows the Diagnostic efficacy of triphasic MDCT for the detection of malignantliver masses.?=0.837; p<0.001(Kappa- test for agreement).

DETAILED DESCRIPTION OF DRAWINGS:
[029] While the present invention is described herein by way of example using embodiments and illustrative drawings, those skilled in the art will recognize that the invention is not limited to the embodiments of drawing or drawings described and are not intended to represent the scale of the various components. Further, some components that may form a part of the invention may not be illustrated in certain figures, for ease of illustration, and such omissions do not limit the embodiments outlined in any way. It should be understood that the drawings and the detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the scope of the present invention as defined by the appended claim.
[030] As used throughout this description, the word "may" is used in a permissive sense (i.e. meaning having the potential to), rather than the mandatory sense, (i.e. meaning must). Further, the words "a" or "an" mean "at least one” and the word “plurality” means “one or more” unless otherwise mentioned. Furthermore, the terminology and phraseology used herein are solely used for descriptive purposes and should not be construed as limiting in scope. Language such as "including," "comprising," "having," "containing," or "involving," and variations thereof, is intended to be broad and encompass the subject matter listed thereafter, equivalents, and additional subject matter not recited, and is not intended to exclude other additives, components, integers, or steps. Likewise, the term "comprising" is considered synonymous with the terms "including" or "containing" for applicable legal purposes. Any discussion of documents, acts, materials, devices, articles, and the like are included in the specification solely for the purpose of providing a context for the present invention. It is not suggested or represented that any or all these matters form part of the prior art base or are common general knowledge in the field relevant to the present invention.
[031] In this disclosure, whenever a composition or an element or a group of elements is preceded with the transitional phrase “comprising”, it is understood that we also contemplate the same composition, element, or group of elements with transitional phrases “consisting of”, “consisting”, “selected from the group of consisting of, “including”, or “is” preceding the recitation of the composition, element or group of elements and vice versa.
[032] The present invention is described hereinafter by various embodiments with reference to the accompanying drawing, wherein reference numerals used in the accompanying drawing correspond to the like elements throughout the description. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiment set forth herein. Rather, the embodiment is provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those skilled in the art. In the following detailed description, numeric values and ranges are provided for various aspects of the implementations described. These values and ranges are to be treated as examples only and are not intended to limit the scope of the claims. In addition, several materials are identified as suitable for various facets of the implementations. These materials are to be treated as exemplary and are not intended to limit the scope of the invention.
[033] The present invention provides a triple-phase multidetector computed tomography of hepatic masses with cytopathological correlation.
[034] This prospective, observational study is conducted in radiodiagnosis department of tertiary care teaching hospital over a period of 18 months from January 2016 to July 2017. Informed written consent is taken from patients about the participation in present study. Ethical clearance is granted by institute ethical committee.
[035] In a recent study El-Sayed EE et al., reported the sensitivity of MDCT in detection of Hepatocellular Carcinomas (HCC) to be 90.3%. In present study we also targeted a similar sensitivity of HCC in a clinically suspicious population. The sample size had been calculated using the modification of a formula suggested by Snedecor GW et al., to prove the hypothesis: n = {C2}/Prevalence Where ‘p’ is taken as the targeted sensitivity (90% or 0.9), C is a constant at a certain confidence level (its value at 90% confidence limit and 80% power is 1.72). ‘e’ is the error allowance which is taken as 10% (0.10) and prevalence of malignancy has been taken as 50% (0.5) in a screened population. Now placing these values in above equation, we get 53.3. After adding for a contingency provision of 4% we get the sample size of 55.
[036] All the patients with clinical diagnosis of hepatic mass underwent liver function test, serum creatinine and ultrasonographic assessment. Total 55 patients with primary USG diagnosis of hepatic mass are included for the study. Patients with USG features suggestive of abscess, hydatid cyst, simple cyst of liver and patients with metallic implant are not enrolled in the study. All examinations are done on 64 slice MDCT. Opacification of digestive tract is achieved by oral administration of diluted 40 mL of ionic contrast in 2 liters of water. The patient is subjected to spiral CT scan and non-contrast 8 mm contiguous axial sections are taken from the level of domes of diaphragm up to the level of third lumbar vertebra.
[037] For an average adult patient nonionic contrast 100 mL, of an ionic concentration of 320 mg I/mL is injected automatically at the rate of 3-5 mL/second with 325 psi intravenously. When contrast reached a HU value of 100 in the aorta, the arterial phase spiral images are obtained. After 25 seconds, the portal venous phase spiral images are obtained and delayed phase images are obtained after 6-10 minutes. Further imaging is done, if required as per the enhancing pattern of liver masses. All of these patients underwent either fine needle aspiration biopsy or core needle biopsy. Cytohistopathological findings are correlated with imaging findings.
[038] All relevant details including history, general clinical examination findings, radiological findings, and cytopathological interpretations are recorded in case reporting form. A database is constituted using SPSS version 22 and electronic Microsoft Excel spreadsheets to store and manage the collected data. Categorical data has been represented as frequency (number) and proportions (percentages). Continuous data has been presented as Mean+Standard deviation (SD). For the analysis of data, ANOVA and Chi-square tests are used. Agreement between different diagnostic modalities is made using Kappa-statistic. The diagnostic efficacy of triphasic MDCT is expressed in terms of sensitivity, specificity, PPV, NPV, and accuracy. The confidence level of the study is kept at 95%, hence a p-value <0.05 is considered as statistically significant.
[039] Total 55 patients, of age 3 years to 85 years, are enrolled in this study with a mean age of 57.53+15.02 years [Table/Fig-1]. The maximum number of patients are aged 61-80 years (43.64%) followed by those aged 41-60 years. In present study 34(61.82%) patients are males. Among presenting clinical symptoms, abdominal pain (90.91%) is the most common; whereas in clinical signs pallor (80.00%), icterus (45.45%), and Lump RHC (18.18%) are the top three signs among the patients [Table/Fig-2]. As per USG assessment, 51/55 (92.73%) cases are malignant and 4/55 (7.27%) benign, including 3 (5.45%) hemangiomas and 1 (1.82%) adenoma.
[040] On triple-phase MDCT assessment, 51 (92.73%) hepatic masses are diagnosed as malignant and remaining 4 (7.27%) are diagnosed as benign [Table/Fig-3]. A total 38 (69%) hepatic masses are diagnosed as liver metastasis while 13 (23.64%) are diagnosed as hepatocellular carcinoma [Table/Fig-4].
[041] Among liver metastasis most common diagnosis is carcinoma gall bladder, in 14 (25.45%) [Table/Fig-5]. There are 6 (10.9%) cases of unknown primary, 2 (3.6%) cases of carcinoma colon and carcinoma periampullary region and 1 (1.82%) case each with carcinoma pancreas, carcinoma oesophagus, carcinoma stomach and renal cell carcinoma [Table/Fig-6]. Out of 55 hepatic masses on cytohistopathology 35 (63.64%)are diagnosed as adenocarcinoma, 13 (23.64%) hepatocellularcarcinoma and one case each diagnosed as small cell carcinoma andmalignant cells, respectively. There are 3 (5.45%) cases diagnosedas adenoma and 2 (3.64%) diagnosed as benign hepatocytes. On the basis of final diagnosis, a total of 50 (90.91%) are identified as malignant while 5 (9.09%) are benign hepatic mass.
[042] Except for 1 histopathologically proven case of benign mass which is wrongly interpreted as metastasis by triphasic CT, all the others are diagnosed perfectly. The level of agreement is excellent (?=0.962; p<0.001) [Table/Fig-7]. Triphasic CT detected 50 true positive, 1 false positive, none false negative and 4 true negative cases. Correspondingly, the sensitivity, specificity, positive and negative predictive values of triphasic CT for diagnosis of malignancy are 100%, 80%, 98.04% and 100% respectively. The method had an accuracy of 98.18% [Table/Fig-8].
[043] In the present study, we made an attempt to characterize 55 such hepatic masses and ended up in characterising 50 (90.9%) of them as malignant and could diagnose only 5 (9.1%) as benign. The malignancy rates in different case series have shown to have a wide variability. Chung YE et al., in their study found a relatively lower malignancy rate at 26.0% . On the other hand Lee HY et al. in their study found the malignancy rate as 34.1%. Böttcher J et al., in their study found 53.1% of lesions as malignant. The evidence from neighboring country, Pakistan as shown by Hafeez S et al., is similar to present study that found a high malignancy rate at 82.2% of patients and in 91.9% of total masses. The other study from the region, the malignancy rate is much higher than these studies Chauhan U et al.. The reasons for the high malignancy rate in this series as well as in some of the other series from this region could be multiple - including poor diagnostic infrastructure, lack of adequate healthcare facilities, dietary habits, alcohol consumption, and treatment of early symptoms as simple gastrointestinal manifestations in the absence of a good primary healthcare structure. It must be kept in mind that most of the benign liver lesions have a high malignancy potential . In the absence of adequate diagnostic facilities and detection at a delayed stage, the overall malignancy rates in our settings are relatively higher than that reported in series from outside. Another reason for high malignancy rate in present study is the strict exclusion criteria used by us. In present study, we excluded all the cases with USG features suggestive of abscess and cysts from inclusion, thus leading to an overall reduction of sampling universe, thus offering higher chances of malignancy detection.
[044] The present study had a dominance of metastatic lesions. The proportion of metastatic masses among suspected liver masses has shown much variability. In their study, Hafeez S et al., found metastatic lesions to be 37.5% of their entire sample. Chauhan U et al., found only 26.7% of their suspected masses to be metastatic. However, Goel S et al., had 42.1% metastatic lesions in their study. One of the reasons for high number of metastatic lesions in present study could be the high prevalence of carcinoma gall bladder in this belt. Interestingly, carcinoma gall bladder is the most common site responsible for metastasis to liver. In present study, overall efficacy of triphasic MDCT in terms of sensitivity, specificity, PPV and NPV is 100%, 80%, 98%, and 100% respectively. The method had an accuracy of 98.2%. Similar to the present study, a high diagnostic efficacy of triphasic MDCT is reported by Hafeez S et al., who reported it to be 100% sensitive and 80% specific. In their study the PPV is 94.6% and NPV is 100%. They found triphastic MDCT to be 95.6% accurate.
[045] The superiority of MDCT in detection of malignancy could be attributable to the ability of different phases based on the vascular nature of masses. However, owing to less number of benign cases, only 1 misdiagnosis in the present study and 2 misdiagnosis in the study by Hafeez S et al., led to loss of specificity by 20%. In another study, that had only 4 benign cases as compared to 31 malignant cases, the sensitivity of MDCT is reported to be 90.3%, however, owing to 2 misdiagnoses, the specificity is dropped down to 50%. In the study which had an adequate number of both benign as well as malignant cases, Goel S et al., found the sensitivity and specificity of triphasic MDCT to be 96.2% and 100%, respectively. Sinha R and Khatri KA, also reported the sensitivity of triphasic MDCT to be 97.6% for the detection of metastasis. In a recent study conducted by Jain S et al., the overall sensitivity and specificity of MDCT for malignant lesions of the liver are 83.3% and 97.2%.
[046] The findings of the present study showed that triphasic MDCT is a useful modality for the diagnosis and characterisation of liver masses, as it provides plentiful information from extra-abdomen primaries and hence is useful in situations where the liver lesions are not caused by a primary lesion and are metastatic in nature. However, less number of benign cases is a big barrier that needs to be surpassed for the exact evaluation of usefulness of this modality. As a matter of fact, being more sensitive as well as specific, its use following a USG assessment seems to be a viable choice.
[047] The disclosure has been described with reference to the accompanying embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein.
[048] The foregoing description of the specific embodiments so fully revealed the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the scope of the embodiments as described herein.

We Claim:

1) A triple-phase multidetector computed tomography of hepatic masses with cytopathological correlation, the observational study comprises 55 patients with a primary diagnosis of hepatic masses on the basis of USG;
wherein a triphasic MDCT scan findings thereof are evaluated and later correlated with histopathology.
2) The observational study as claimed in claim 1, wherein categorical data has been represented as frequency (number) and proportions (percentages), and continuous data as Mean±Standard Deviation (SD).
3) The observational study as claimed in claim 1, wherein ANOVA and Chi-square tests are used.
4) The observational study as claimed in claim 1, wherein among 55 patients, 4 (7.27%) are benign and 51 (92.73%) are malignant cases detected with the help of USG, and the same is verified on the basis of triphasic CT assessment.
5) The observational study as claimed in claim 1, wherein on histopathology, 50 (90.91%) are identified as malignant lesions while 5 (9.09%) cases are diagnosed as benign lesions.
6) The observational study as claimed in claim 1, wherein a triphasic CT scan has a sensitivity of 100%, specificity of 80%, positive Predictive Value (PPV) of 98.04%, Negative Predictive Value (NPV) of 100%, and diagnostic accuracy of 98.18% in differentiating benign liver lesions from malignant liver lesions.

7) The observational study as claimed in claim 1, wherein early and accurate diagnosis of liver lesions is the foremost requirement in treatment.

8) The observational study as claimed in claim 1, wherein a triple-phase MDCT scan along with USG can solve this and recommended in every suspected hepatic mass.