Title of Guideline (must include the word Guideline (not protocol, policy, procedure etc)

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1 Title of Guideline (must include the word Guideline (not protocol, policy, procedure etc) Author: Contact Name and Job Title Directorate & Speciality Assessment, referral and initial management of ultrasound detected ovarian cysts for NUH gynaecology teams Kate Stewart ST7, David Nunns Consultant Gynaecological Oncologist, NUH Family Health Date of submission Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis) Women seen in gynaecology clinics or emergency admissions areas Version 7 If this version supersedes another clinical guideline please be explicit about which guideline it replaces including version number. Statement of the evidence base of the guideline has the guideline been peer reviewed by colleagues? Evidence base: (1-6) 1 NICE Guidance, Royal College Guideline, SIGN (please state which source). 2a meta analysis of randomised controlled trials 2b at least one randomised controlled trial 3a at least one well-designed controlled study without 3b randomisation at least one other type of well-designed quasiexperimental study 4 well designed non-experimental descriptive studies (ie comparative / correlation and case studies) 5 expert committee reports or opinions and / or clinical experiences of respected authorities 6 recommended best practise based on the clinical experience of the guideline developer Consultation Process Ratified by: Date: Target audience NA 1) RCOG (2003), Green-Top Guideline no. 34, Ovarian cysts in post -menopausal women, The Royal College of Obstetricians and Gynaecologists 1) RCOG (2011) Green-Top Guideline no. 62, Management of Suspected Ovarian Masses in Pre-menopausal women, The Royal College of Obstetricians and Gynaecologists 1) NICE 2011 NICE Clinical Guideline number 122: Ovarian Cancer: the recognition and initial management of ovarian cancer National Institute for Health and Clinical Excellence 5) IOTA onal-material Senior medical staff, radiology Gynae risk management group 21 st November 2016 General gynaecologists Review Date: (to be applied by the Integrated Governance Team) A review date of 5 years will be applied by the Trust. Directorates can choose to apply a shorter review date, however this must be managed through Directorate Governance processes. This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date.

2 Aims and purpose To guide the clinician (general gynaecologists all grades) on the assessment, referral and initial management of ultrasound scan detected ovarian cysts. Algorithm for the management of ovarian cysts on USS (please see main text for detail) Background Up to 10% of women will have some form of surgery for the presence of an ovarian mass. In premenopausal women almost all ovarian masses and cysts are benign and many ovarian masses in this group can be managed conservatively The underlying management rationale is to minimise patient morbidity by: o conservative management where possible providing necessary reassurance o use of laparoscopic techniques where appropriate, thus avoiding laparotomy 1

3 o referral to a gynaecological oncologist where appropriate. It should be noted that almost all pelvic ultrasound scan requests will require a transvaginal scan (TVS). TVS is almost always superior to transabdominal ultrasound (TAS) for examining the pelvic organs. However, some women cannot accommodate a vaginal scan probe and can only have an abdominal scan. At the present time the routine use of CT and MRI for assessment of ovarian masses does not improve the sensitivity or specificity obtained by transvaginal ultrasonography in the detection of ovarian malignancy and should be reserved as second line investigation after discussion with a senior colleague. However, if the mass is larger than the array of the scanning probe or if there are diagnostic difficulties with the USS then a CT/MRI may be indicated. It is important to consider borderline ovarian tumours as a histological diagnosis when undertaking any surgery for ovarian masses and, when such a histological diagnosis is made or strongly suspected, discussion with the gynaeoncology team is recommended. Although up to 20% of borderline ovarian tumours appear as simple cysts on ultrasonography, the majority of such tumours will have suspicious ultrasonographic findings. 2

4 1.Tumour markers Tumours marker (such as Ca125) is used as a part of patient triage and risk assessment. They are not diagnostic and lack good sensitivity and specificity. Measure serum CA125 in all women with suspected ovarian cancer A serum CA-125 assay does not need to be undertaken in all premenopausal women when an USS diagnosis of a simple ovarian cyst has been made. In women under age of 40 years with suspected ovarian cancer also measure: levels of alpha fetoprotein (AFP), beta human chorionic gonadotrophin (beta-hcg) as well as serum CA125, to identify germ cell tumours. 2. Evaluation of ovarian masses in premenopausal women Please consider this triage tool for premenopausal women with ovarian cysts. The International Ovarian Tumour Analysis Group has published the largest study to date investigating the use of ultrasound in differentiating benign and malignant ovarian masses based on five ultrasound features of malignancy (M-features) and five ultrasound features suggestive of a benign lesion (B-features). An adnexal mass is classified as malignant if at least one M-feature and no B-features are present and vice versa. Using these rules the reported sensitivity was 95% and specificity 91% (see table below). Some scan reports may not contain this level of detail. If unsure please discuss with a senior colleague. IOTA Group ultrasound rules to classify masses as benign (Brules) or malignant (M-rules) B-rules Unilocular cysts Presence of solid components where the largest solid component <7 mm Presence of acoustic shadowing Smooth multilocular tumour with a largest diameter <100mm No blood flow M-rules Irregular solid mass (solid component 80% of the tumour) Presence of ascites At least 4 papillary structures with a height equal or more than 3mm Irregular multi-locular solid tumour with a maximum diameter > 10cm Strong vascularity 3

5 Women with an ovarian mass with any of the M-rules ultrasound findings should be discussed with the gynaecological oncological service. Please check the patients Ca -125 when referring. 2.1 Premenopausal cysts follow up The following cysts should be treated as simple cysts: Ovarian/para-ovarian cyst, cysts containing daughter cysts, Cysts with one thin septation (<3mm, with no vascularity), Cysts with small calcification in wall. If there is an obvious area of calcification; consider whether this may be a dermoid cyst. Cyst criteria apply even if cysts are multiple (cysts completely separate from each other) or bilateral. Pre-menopausal cysts Less than 5cm 5-7cm more than 7cm Simple/ Haemorrhagic cyst Endometrioma/ dermoid Ovarian cysts with any malignant features (see IOTA criteria in above table) No follow up required unless there is clinical concern. Findings are likely to be physiological in nature and almost always resolve within 3 menstrual cycles. Suggest rescanning in four months. If smaller or resolved no further follow up required. If larger or persisting suggest further gynaecological review. Ovarian cysts that persist or increase in size are unlikely to be functional and may warrant surgical management. If symptomatic, for benign gynaecological review. Suggest benign gynaecological team review re: surgery depending on clinical assessment Manage on clinical grounds No routine rescans indicated as less likely to change in size Take CA-125 and calculate RMI. Consider germ cell tumour markers (AFP, HCG and LDH). Discuss with the gynaeoncology team. 3. Evaluation of ovarian masses in post-menopausal women 3.1 Calculate the Risk of Malignancy Index Score (RMI) Please consider the RMI triage tool for postmenopausal women with ovarian cysts to identify patients at risk of ovarian cancer. Calculate a risk of malignancy index I (RMI) score and refer all women with an RMI score of 200 or greater to the gynaeoncology MDT using the intranet referral form. The use of RMI scoring is not appropriate when obvious metastatic disease has been identified by ultrasound. 4

6 In this case a CT scan chest abdomen and pelvis would be more appropriate (patients require a GFR for IV contrast). The pooled sensitivities and specificities of an RMI I score of 200 in the detection of ovarian malignancy are sensitivity 78% (95% CI 71-85%) and specificity 87% (CI 83-91%) The value is less in premenopausal women where Ca-125 levels may be raised with benign conditions eg, endometriosis. RMI score = ultrasound score x menopausal score x CA125 in U/ml. Feature RMI score Ultrasound multilocular cyst 0= none solid areas 1= one abnormality bilateral lesions 3= two or more abnormalities ascites intra-abdominal metastases Premenopausal 1 Post menopausal 3 Ca 125 U/ml A full physical examination of the woman is essential and should include body mass index, abdominal examination to detect ascites and characterise any palpable mass, and vaginal examination. A thorough medical history should be taken from the woman, with specific attention to risk factors and symptoms suggestive of ovarian malignancy, and a family history of ovarian, bowel or breast cancer. Where family history is significant, referral to the Regional Cancer Genetics service should be considered. 3.2 Follow up for post-menopausal Ovarian Cysts Assess ovarian cysts in postmenopausal women using CA125 and transvaginal ultrasound scan and calculate the RMI There is no routine role yet for Doppler, MRI, CT or PET. The risk of malignancy in these studies of cysts that are less than 5 cm, unilateral, unilocular and echo-free with no solid parts or papillary formations is less than 1%. In addition, more than 50% of these cysts will resolve spontaneously within three months. Thus, it is reasonable to manage cysts of 2 5 cm conservatively. Conservative management should entail repeat ultrasound scans and serum CA125 measurement every four months for one year. If the cyst does not fit the above criteria or if the woman requests surgery then laparoscopic oophorectomy is acceptable. 5

7 Postmenopausal cysts Less than 3cm 3-5cm More than 5cm Simple ovarian cysts Dermoid cysts Ovarian cysts with any malignant features (see IOTA criteria in above table) or not simple If the cyst is small with no worrying features, this is most likely to be a residual follicle. No further scan is indicated. No immediate action is indicated manage on clinical grounds Suggest rescan with CA-125 measurement in four and eight months. If no change demonstrated in these scans, no further imaging indicated unless clinical concern. Suggest gynaecological referral. No rescan indicated Suggest benign gynaecological team referral. Calculate RMI and discuss if appropriate with the gynaeoncology team Suggest benign gynaecological team referral. Calculate RMI and discuss if appropriate with the gynaecological oncological team Take CA-125 and calculate RMI. Discuss with the gynaeoncology team. 4. Special scenarios 4.1 Patients with co-morbidities The decision for surgery may be weighed against the patients comorbidities and a conservative option of management may be taken after discussion with the patient and her consultant. 4.2 Emergency management of cysts Any cyst that is causing severe symptoms may warrant emergency surgery. This should be done in daytime hours. If woman attends as an emergency with an ovarian cyst causing pain but does not warrant surgery she can be followed up as per guidelines above in Miss Jhamb s Thursday afternoon scan clinic (book with A23 reception) 4.3 Ovarian torsion Ovarian torsion accounts for approximately 1 in 5 of emergency gynaecology admissions. It is frequently described as unilateral ovarian enlargement and oedema on USS and has a strong association with large (>5cm) ovarian cysts. These cysts become haemorrhagic with venous congestion. 6

8 Traditionally, surgery has involved partial or complete oophorectomy or salpingo-oophorectomy. There is evidence to suggest that the clinical appearances of torted adnexae do not correlate well with the likelihood of residual ovarian function and recovery and there are good outcome data to support conservative management with laparoscopic de-torsion in the majority of cases with little short or long-term associated morbidity even if the ovary appears dark purple or black. True cysts can be drained at the time to maximise ovarian conservation. Follow up after detorsion should be by scan in Miss Jhamb s emergency gynaecology Thursday afternoon clinic to determine the presence of any true cysts that may require interval cystectomy. 4.4 Management of cysts in pregnancy Asymptomatic adnexal masses are frequently diagnosed in pregnancy, either at the dating scan or at the time of caesarean section. They are mostly ovarian in origin. Although the overall incidence of adnexal masses in pregnancy is approximately 4%, the incidence of complex or simple persistent cysts measuring more than 6 cm is only 0.07%. Three-quarters of these persistent cysts are complex in nature and the majority of complex cysts are either benign teratomas or endometriomas. Ovarian cysts in pregnancy can result in cyst rupture, cyst haemorrhage, torsion (up to 5%), obstructed labour and fetal malpresentation The majority of ovarian cysts in pregnancy are benign and can be managed conservatively. Ovarian cancer is extremely rare in women of childbearing age, the overall reported incidence of ovarian cancer in pregnant women varies from %, If there is a suspicion of malignancy or there is a significant cyst complication, such as torsion, and surgery is planned, this should take place during the second trimester to minimise the risk of miscarriage MRI in pregnancy MRI is considered safe in pregnancy (without contrast) and can be helpful in the assessment of an ovarian mass that is thought to be malignant Tumour markers in pregnancy CA 125 (epithelial cancer) BHCG Effect of pregnancy Raised during pregnancy due to decidual cell production. Some researchers have suggested using a cut-off level of 112 U/ml 7

9 (germ cells tumours) AFP (germ cells tumours) Inhibin (granulosa and mucinous) LDH (malignant germ cell tumours) Serum AFP, betahcg and inhibin levels are all raised due to placental synthesis Due to the rarity of this neoplasm, data regarding this association is sparse NB. Is it worth doing tumour markers as a normal result will be reassuring Algorithm for management of ovarian cyst in pregnancy (Ref: TOG article, Spencer et al) Inform women that the majority of ovarian cysts resolve spontaneously. Dermoid cysts that are less than 6cm on rescan can be followed up 3 months postnatally to determine further management. Large simple cysts can be drained by USS guided needle aspiration if very symptomatic and is done by the interventional radiologist after multidisciplinary discussion. This should be done after 14weeks to minimise disturbance to the corpus luteum. If a complex cyst is causing severe symptoms it can be operated upon after 14 weeks to minimise the risk of fetal loss due to miscarriage, although this risk is very small. In some situations, there may be grounds for performing an elective caesarean section at term in addition to deal with a large, 8

10 complex ovarian tumour that has persisted during the pregnancy but which has not required earlier operative intervention. References: Ameye L, Timmerman D, Valentin L, Palandini D, Zhang J, Van Holsbeke C, Lissoni A, Savelli L, Veldman J, Testa A, Amant F, Van Huffel S, Bourne T (2012), Clinically oriented three-step strategy for assessment of adnexal pathology, Ultrasound in Obstetrics and Gynaecology 40: pp Breijer M., Peeters J., Opmeer B., Clark T., Verheijen R., Mol B., and Timmermans A. (2010), Capacity of endometrial thickness measurement to diagnose endometrial carcinoma in asymptomatic postmenopausal women: a systematic review and meta-analysis, Ultrasound in Obstetrics and Gynecology, Vol. 40:6, Damigos E, Johns J, Ross J. An update on the diagnosis and management of ovarian torsion. The Obstetrician & Gynaecologist. 2012;14: Europeam Society of Human Reproduction and Embryology (ESHRE) (2013), Management of women with endometriosis: Guideline of the European Society of Human Reproduction and Embryology, European society of human reproduction and embryology Hartman A., Wolfman W., Nayot D., Hartman M., (2013) Endometrial Thickness in 1,500 Asymptomatic Postmenopausal Women Not on Hormone Replacement Therapy; Gynecologic and Obstetric Investigation, Vol. 75: Levine D, Brown DL, Andreotti RF, Benacerraf B, Benson CB, Brewster WR, Coleman B., DePriest P., Doubilet P., Goldstein S., Hamper U., Hecht J., Horrow M., Hur H., Marnach M., Patel M., Platt L., Puscheck E. and Smith-Bindman R. (2010), Management of asymptomatic ovarian and other adnexal cysts imaged at US: Society of Radiologists in Ultrasound Consensus Conference Statement. Radiology, Vol. 256 (3): Kaijser J., Bourne T., Valentin L., Sayasneh A., Van Holsbeke C., Vergote I., Testa A., Franchi D., Van Calster B. and Timmerman D. (2013), Improving strategies for diagnosing ovarian cancer: a summary of International Ovarian Tumor Analysis (IOTA) studies, Ultrasound Obstetrics and Gynecology, Vol. 41:1, 9-20 Kaijser J.(2015) Towards an evidence-based approach for diagnosis and management of adnexal masses: findings of the International Ovarian 9

11 Tumour Analysis (IOTA) studies, Facts, Views and Vision in OBGYN 7 (1), pp Nunes N, Ambler G, Foo X, Naftalin J, Widschwendter M, Jurkovic D 2014, Use of IOTA simple rules for diagnosis of ovarian cancer: meta - analysis, Ultrasound in Obstetrics and Gynaecology 44, pp NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE (NICE) 2011 NICE Clinical Guideline number 122: Ovarian Cancer: the recognition and initial management of ovarian cancer National Institute for Health and Clinical Excellence The Royal College of Obstetricians and Gynaecologists: Green-Top Guideline no. 34, Ovarian cysts in post -menopausal women, The Royal College of Obstetricians and Gynaecologists (2016), The Royal College of Obstetricians and Gynaecologists: Green-Top Guideline no. 62, (2011) Management of Suspected Ovarian Masses in Pre-menopausal women, The Royal College of Obstetricians and Gynaecologists Scottish Intercollegiate Cancer Network (SIGN) Guideline No 75. Epithelial Ovarian Cancer. October ISBN Spencer CP, Robarts PJ. Management of adnexal masses in pregnancy. The Obstetrician & Gynaecologist 2006;8: Review date