International Journal of Medical and Health Sciences

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1 International Journal of Medical and Health Sciences Journal Home Page: ISSN: Original article Comparison Of Imaging Modalities In Abnormal Uterine Bleeding : Correlation With Hysteroscopic guided Biopsy Vasanthi V 1*, Prabha Ganapathy 2, Indira N 3, Chinnappa Kokatnoor 4 1&4 DNB Post Graduates, 2 Professor & HOD, 3 Assistant Professor, Department of Obstetrics and Gynaecology, Public Health Centre Hospital, Lake View Road, West Mambalam, Chennai 33, Tamil Nadu, India. ABSTRACT Introduction: Transvaginal ultrasound is conventionally used in patients with abnormal uterine bleeding but saline infusion sonography is a better technique to reliably distinguish focal from diffuse endometrial lesions. This study was performed to compare the ability of transvaginal ultrasonography and saline sonography as initial modality for the diagnosis of endometrial abnormalities in women with abnormal uterine bleeding. Materials and Methods: In a prospective study, 50 women with abnormal uterine bleeding were included, sequential examination was conducted by transvaginal ultrasound, and saline sonography. The presence of focal endometrial lesions and the type of lesion (thickened endometrium, polyp, submucous myoma, atrophic endometrium) were noted. Predictive values were calculated by correlating the results with final diagnosis reached by hysteroscopy and endometrial biopsy. Results: The saline sonography had 90% sensitivity and 100% specificity compared to 77% sensitivity and 85% specificity achieved by transvaginal sonogram. There was 91% agreement between saline sonography and hysteroscopy as compared to 69% for TVS (p = 0.000). The diagnostic performance of saline sonography for 3 main endometrial abnormalities (i.e. endometrial hyperplasia, polyps and submucous myoma) was better than transvaginal sonogram. The best results were seen in cases of submucous myoma where sensitivity and specificity of Transvaginal sonogram & saline sonography were100% respectively. Conclusion: Saline sonography is a better tool than transvaginal sonogram for the assessment of endometrial intra-cavity lesions. By providing accurate differentiation between focal and diffuse endometrial lesions, it can help in decision making regarding selection of cases for hysteroscopy and directed biopsy. Hence, saline sonography can be used as an initial investigation in cases of abnormal uterine bleeding. KEYWORDS: Endometrial lesions, Hysteroscopy, Saline infusion sonography, Transvaginal ultrasound. INTRODUCTION Abnormal uterine bleeding is one of the common conditions encountered by the gynecologists. Ultrasound imaging of the reproductive organs especially by transvaginal route has come to the rescue of gynecologists. Its high frequency transducers and close proximity to the organs aid in diagnosing intrauterine pathologies with 83% sensitivity and 70.6% specificity. Goldstein et al[1] advocates the routine use of ultrasound in gynecological consultations, referring to it as Ultrasound- enhanced bimanual examination. In women with abnormal uterine bleeding, the causes may vary from simple dysfunctional uterine bleeding without any organic cause to endometrial cancer. The cases of Abnormal Uterine bleeding usually needs thorough investigation to rule out organic causes especially at perimenopausal and postmenopausal age when the risk of endometrial carcinoma is 10% to 15%[2]. Transvaginal sonogram (TVS) plays a major role as an initial modality for evaluation of AUB[3], but its accuracy in the diagnosis of focal endometrial lesions is limited. The finding of a thickened central endometrial complex seen on TVS is often non-specific and may be caused by an endometrial polyp, submucosal fibroid, endometrial hyperplasia, carcinoma or cystic atrophy. Focal lesions are underdiagnosed at TVS because of limitations of the doublelayer thickness evaluation[3]. Int J Med Health Sci. April 2016,Vol-5;Issue-2 99

2 Saline infusion sonography (SIS) is a technique in which the endometrial cavity is distended with saline during ultrasonic examination and it enables the sonologist to reliably distinguish focal from diffuse endometrial pathologic conditions. It is an easy, fast and well tolerated diagnostic method, hence may be indicated in situations in which conventional TVS cannot assure the normality of the uterine cavity or in which TVS detects an abnormality but cannot be used to define its nature. Hysteroscopy with directed biopsy, over the years, has assumed the role of reference standard investigation for AUB because it is an accurate method for diagnosing and treating endometrial abnormalities. However, the invasive nature and high cost of hysteroscopy has precluded its use as a primary diagnostic procedure rather it can be used for treating endometrial lesions in patients with AUB[4]. This study was performed to compare the efficacy of transvaginal sonogram and saline infusion sonography as an initial modality for the diagnosis of endometrial abnormalities in women with abnormal uterine bleeding by correlating the results with hysteroscopy guided biopsy. MATERIALS AND METHODS This Prospective comparative study was conducted after approval from Institutional Ethical Committee and informed consent was obtained from all the patients. This study was done in the department of Obstretrics and Gynaecology, Public health centre hospital, Chennai, Tamil Nadu over a period of June 2014 to June 2015 ( One Year) with 50 patients who had abnormal uterine bleeding. Patients with vaginal bleeding that was marked enough to warrant further diagnostic evaluation only were included in the study. The patients who did not undergo the sequential evaluation by all three modalities (TVS, SIS, and Hysteroscopic guided biopsy) were excluded. The patient s ages ranged from 40 to 65 years (mean age ranged from 46.22, SD 4.929). Among the 50 women, 47 were perimenopausal and 3 were postmenopausal. All 50 patients were first evaluated on the same day with TVS followed by SIS, followed by hysteroscopic guided biopsies scheduled within one week. Transvaginal Ulrasound was done using Aloka 7.5 MHz transvaginal probe in all the patients to detect any uterine, ovarian or other pelvic pathology. Endometrial thickness was measured. The endometrium was evaluated in the postmenstrual period in premenopausal women. ET >8 mm in perimenopausal and ET >5mm in postmenopausal women were considered abnormal. The presence of focal endometrial thickening or a focal mass was noted. Saline infusion sonography was performed by placing the patient in dorsal lithotomy position and placing a speculum into the vagina to expose the cervix. The external os was cleansed with povidone iodine solution. No.4 or 5 Karmans cannula was inserted through the cervical canal into the uterine cavity without dilatation of cervix. The transvaginal probe was inserted and approximately 10 ml of sterile water was injected slowly under sonographic visualization. The endometrial cavity was examined for the presence of polyps, submucous fibroid, thickened endometrium or atrophic endometrium. Following TVS and SIS procedures, all the patients underwent hysteroscopic evaluation of the endometrium and directed biopsy using 5mm scope. The appearance of endometrium like atrophic, hyperplastic, proliferative or secretory and focal lesions like polyps, submucous fibroid are taken into consideration. Findings of proliferative and secretory endometrium are considered as normal. Hysteroscopic guided biopsy of the endometrium, polypectomy and myomectomy was done during the procedure and the specimens were sent for histopathological examination in 10% formalin solution. The sensitivity, specificity, positive and negative predictive values of TVS and SIS were calculated by comparing the results of each method with hysteroscopic guided biopsy. To find the significance in categorical data, Chi square test was used. p value of <0.01 was taken as significant outcome. Kappa statistics were used for the evaluation of observer agreement. RESULTS The tolerance of Saline infusion sonography procedure was excellent and all examinations were completed successfully. Amongst the symptoms, Menorrhagia constituted the maximum of 58%. On comparing the findings of TVS, SIS with Hysteroscopic guided biopsy, our final results confirmed Endometrial polyp in 15, Endometrial hyperplasia in 9, submucosal myoma in 5, and Atrophic endometrium in 1 patient. The discrepancy between TVS and final diagnosis was present in 5 cases. The 5 false negative cases diagnosed included 3 endometrial polyps and 2 were endometrial hyperplasia. Out of 13 endometrial hyperplasia, 7 were confirmed by HPE, remaining 6 were found to be polyps on hysteroscopy and histopathology. Chi square test showed p value of 0.00 which was statistically significant [Table 1]. Assessing the diagnostic performance of TVS and SIS for endometrial abnormalities such as endometrial polyp, endometrial hyperplasia, submucous myoma and atrophic endometrium showed the sensitivity and specificity of SIS for diagnosing these lesions were better than those of TVS. Out of 15 cases of polyps, 14 were diagnosed by SIS while only 6 were diagnosed by TVS. The best results were seen with submucous fibroid and Atrophic endometrium which were diagnosed equally by all three modalities [Table 2]. Int J Med Health Sci. April 2016,Vol-5;Issue-2 100

3 Table 1: Findings Of Transvaginal sonogram and Saline Sonography with Hysteroscopic guided Biopsy Findings Transvaginal sonography (TVS) Saline infusion sonography (SIS) Hysteroscopic guided biopsy Normal 25(50%) 23(46%) 20(40%) Polyp 6(12%) 14(28%) 15(30%) Hyperplasia 13(26%) 7(14%) 9(18%) Sub mucous fibroid 5(10%) 5(10%) 5(10%) Atrophy 1(2%) 1(2%) 1(2%) Table 2: Diagnostic Performance of TVS and SIS in identifying various lesions Lesions Variables Endometrial Polyp Endometrial Hyperplasia Submucous myoma TVS (%) SIS(%) TVS(%) SIS(%) TVS(%) SIS(%) Sensitivity Specificity PPV NPV Diagnostic performance of TVS and SIS in comparison to hysteroscopic guided biopsy proved that the SIS was more sensitive and specific as compared to TVS alone. The sensitivity and specificity of TVS were 66.7% and 75%, as compared to sensitivity and specificity of SIS were 90% and 100% respectively. The positive predictive value of SIS was 74% as compared to 100% for SIS. Overall diagnostic accuracy of TVS was 68% while for SIS, it was 95% [Table 3]. Value of agreement, the kappa value of TVS was 0.11 showing slight agreement as we had the limiting factor of 2D USG, because of which there was difficulty in differentiating diffuse lesions from focal lesions especially polyps. While for SIS, it was 0.87 showing perfect agreement compared to hysteroscopic guided biopsy which helped in delineating the focal lesion like polyp from diffuse lesion like hyperplasia and p value was which was statistically significant. Thus Transvaginal ultrasound if done along with Saline infusion sonography can help in differentiating diffuse lesion from focal lesion, by which the results are almost similar to hysteroscopic guided biopsy [Table 4]. Table 3: Diagnostic performance of TVS and SIS in identifying various lesions Tests Sensitivity (%) Specificity (%) PPV (%) NPV (%) Diagnostic Accuracy (%) TVS * SIS * - p value (statistically significant), - p value (statistically significant) Table 4: Value of Agreement in identifying lesions - Kappa Values for TVS & SIS Findings TVS (kappa) SIS (Kappa) p value Polyp Hyperplasia Submucous fibroid Atrophy Overall Interpretation : slight agreement fair agreement moderate agreement substantial agreement perfect agreement Int J Med Health Sci. April 2016,Vol-5;Issue-2 101

4 DISCUSSION Transvaginal ultrasound has been used extensively as a basic investigation for the evaluation of patients with AUB. Many previous studies in the literature have substantiated that TVS was quite a sensitive method to evaluate abnormal uterine bleeding. In this study, we compared Transvaginal sonogram and Saline infusion sonography with Hysteroscopy and HPE, which is currently the gold standard for uterine cavity evaluation. It is important to emphasize that we compared office SIS with diagnostic hysteroscopy under general anesthesia. Hysteroscopy under general anesthesia is easy to perform and more accurate than office hysteroscopy. Therefore, our results with regards to diagnostic hysteroscopy are almost certainly superior to those that one would expect from office hysteroscopy. We chose to perform diagnostic and operative hysteroscopy under general/regional anesthesia to maximize the chance of arising at a correct histological diagnosis that could be used as a gold standard. Our most important finding is that SIS is as accurate as Hysteroscopy with a very high sensitivity for detecting intrauterine abnormalities. SIS is an accurate diagnostic tool in the evaluation of uterine cavity in pre and postmenopausal women complaining of abnormal uterine bleeding. SIS if done along with TVS improves the sensitivity. In our study in diagnosing a polyp, TVS showed sensitivity of only 40% & NPV of 79.5%, when compared with study by Veena et al[5] who did a study in 90 patients with role of Transvaginal Sonography and Diagnostic Hysteroscopy in Abnormal Uterine Bleeding in Bangalore, Karnataka, India, where the sensitivity & NPV were 92% & 95.4%, but the specificity & PPV were 100%. In the present study TVS showed 100% sensitivity, specificity, PPV, NPV in diagnosing submucous fibroid while in a study done by Muhammad Aslam et al[6] the sensitivity, specificity & PPV were 61.5%, 97.6%, 88.8%. In our study, TVS showed 77.8% sensitivity, 85% specificity, 53.8% PPV & 94.4% NPV in diagnosing hyperplastic endometrium which was almost comparable to the study done by who had sensitivity & specificity of 36.5% & 97.1%, PPV & NPV of 60% & 91%. In present study the sensitivity, specificity, PPV and NPV of SIS in diagnosing a polyp were 93.3%, 100%, 100% and 97.2% respectively. The diagnostic potential of SIS in diagnosing a polyp in our study was comparable to the study done by Brig S Rudra et al[7] who had sensitivity & specificity of 93% & 94.1% and PPV & NPV of 92.9% & 98.1%. The sensitivity, specificity, PPV and NPV of SIS in diagnosing submucous fibroid were 100% each which was similar to the study done by Kelekci et al[8]. In present study SIS had a sensitivity of 77.8%, specificity of 100%, PPV of 100%, NPV of 95.3%. The results were comparable with the study done by Schwarzler et al[9] who had sensitivity, specificity, PPV & NPV of 87%, 91%, 92% & 86%. The overall diagnostic potential of TVS & SIS in our study was comparable to the study done by Ritu Mishra et al[10] who did a study with 280 patients in Kanpur, Uttar Pradesh, India. In both the studies the specificity and PPV of TVS was 74% whereas with SIS it was 100% in our study while they had 84% each. The agreement between TVS and Hysteroscopy in detecting intracavitary lesions was calculated. In the present study the kappa values of Polyp, Hyperplasia, Fibroid and Atrophy were 0.48, 0.54, 1.00 & 0.02 with a p value of (statistically significant), which was comparable to the study done by Veena et al[5] in which their kappa value were 0.33, 0.43, 0.73 and 0.61 for polyp, hyperplasia, fibroid and atrophy respectively with p value of <0.001 which was statistically significant. The agreement between SIS and Hysteroscopy in detecting intracavitary lesions were calculated. Overall kappa value was 0.87, with p value of <0.000 showing perfect agreement. Kappa value is comparable with the results of Epstein et al[11], which was 0.80, p value was <0.005, which was statistically significant. In our study, the diagnostic accuracy of SIS in diagnosing focal endometrial lesions (polyp, fibroid) is better than the diffuse endometrial pathology (hyperplastic, atrophic endometrium). However accurate distinction between hyperplasia and disordered proliferative endometrium still requires histological examination. Our findings and detection rate of various lesions are in agreement with various other studies. The advantage of SIS over Hysteroscopy is that it does not require anesthesia. SIS scores over Hysteroscopy in avoiding the need of anaesthetic intervention in elderly patients and in patients with co-morbid conditions. Hence, TVS which is routinely done can be combined with SIS to improve the results. The high sensitivity, specificity and diagnostic accuracy of SIS makes it a good predictor of necessity and type of further surgical intervention. CONCLUSION Transvaginal sonogram with Saline infusion sonography can be used as the first line investigation for AUB in perimenopausal and postmenopausal women. Saline infusion sonography is a better tool as compared to transvaginal ultrasound for the assessment of endometrial intra-cavity lesions. By providing accurate differentiation between focal and diffuse endometrial lesions, saline infusion sonography can help in decision making regarding selection of cases for hysteroscopy and/or hysteroscopic guided biopsy. The diagnostic accuracy of SIS makes it an excellent choice in the evaluation of intrauterine abnormalities in Abnormal uterine bleeding and hence, it can replace diagnostic hysteroscopy in low resource settings. Larger multicentric studies are needed to confirm our results. REFERENCES 1. Goldstein SR, Zeltser I, Horan CK. Ultrasonography based triage for perimenopausal patients with abnormal uterine bleeding. Am J Obstet Gynecol 1997;177: Int J Med Health Sci. April 2016,Vol-5;Issue-2 102

5 2. Holst J, Koskela O, Von Schoultz B. Endometrial findings following curettage in 2018 women according to age and indications. Ann Chir Gynaecol 1983;72: Dubinsky TJ, Parvey HR, Maklad N. The role of transvaginal sonography and endometrial biopsy in the evaluation of peri and postmenopausal bleeding. AJR Am J Roentgenol 1997; 169: Bree RL, Bowerman RA, Bohm-Velez M, Benson CB, Doubilet PM, DeDreu S. Ultrasound evaluation of the uterus in patients with postmenopausal bleeding: a positive effect on diagnostic decision making. Radiology 2000; 216: Veena.B.T, Nirmala Shivalingaiah. Role of Transvaginal Sonography and Diagnostic Hysteroscopy in Abnormal Uterine Bleeding. Journal of Clinical and Diagnostic Research Dec, Vol-8(12): OC06-OC08 6. Muhammad Aslam, Lubna Ijaz, Shamsa Tariq, Kausar Shafqat, Meher-un-Nisa, Rubina Ashraf, and Tahira Kazmi. Comparison of Transvaginal Sonography and Saline Contrast Sonohysterography in Women with Abnormal Uterine Bleeding: Correlation with Hysteroscopy and Histopathology. Int J Health Sci (Qassim) Jan; 1(1): Brig S Rudra,(2009) Col BS Duggal,. Prospective study of saline infusion sonography and office hysteroscopy. MJAFI 2009; 65: Kelekci S, Kaya E, Alan M, Alan Y, Bilge U. Comparison of Transvaginal sonography, saline infusion sonohysterography & office hysteroscopy in reproductive aged women with or without abnormal uterine bleeding. Fertil steril, 2005 Sep; 84(3): p Schwärzler P, Concin H, Bosch H, Berlinger A, Wohlgenannt K, Mischell DR. An evaluation of sonohysterography and diagnostic hysteroscopy for the assessment of intrauterine pathology. Ultrasound Obstet Gynecol 1998; 11: Ritu Mishra, Aditya Prakash Misra, Yashoda Mangal. Comparing the results of TVS and SIS with Hysteroscopy & Histopathological examination in perimenopausal & postmenopausal bleeding. Journal of Evolution of Medical and Dental Sciences 2015; Vol. 4, Issue 07, January 22; Page: Epstein E, Ramirez A, Skoog L, Valentin L. Transvaginal sonography, saline contrast sonohysterography and hysteroscopy for the investigation of women with postmenopausal bleeding and endometrium >5mm. Ultrasound obstet Gynaecol 2001 Aug 18: *Corresponding author: Dr. Vasanthi V vasanthivaradhan@yahoo.co.in Int J Med Health Sci. April 2016,Vol-5;Issue-2 103