Digestive and Liver Disease 47 (2015) 797–804

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Digestive and Liver Disease journal homepage: www.elsevier.com/locate/dld

Oncology

An urgent referral strategy for symptomatic patients with suspected colorectal cancer based on a quantitative immunochemical faecal occult blood test Lorena Rodríguez-Alonso a , Francisco Rodríguez-Moranta a,c , Alexandra Ruiz-Cerulla a , Triana Lobatón a , Clàudia Arajol a , Gemma Binefa b,c , Victor Moreno b,c,d , Jordi Guardiola a,∗ a

Department of Gastroenterology and Hepatology, University Hospital of Bellvitge-IDIBELL, L’Hospitalet de Llobregat, Barcelona, Spain Catalan Institute of Oncology, Cancer Prevention and Control Programme, IDIBELL, L’Hospitalet de Llobregat, Barcelona, Spain c Ciber de Epidemiología y Salud Pública (CIBERESP), Spain d Department of Clinical Sciences, Faculty of Medicine, University of Barcelona, Barcelona, Spain b

a r t i c l e

i n f o

Article history: Received 15 October 2014 Accepted 5 May 2015 Available online 15 May 2015 Keywords: Colorectal cancer Diagnostic accuracy study Faecal immunochemical test Fast-track referral

a b s t r a c t Background: European health systems have developed referral guidelines for the selection of patients for the urgent investigation of suspected colorectal cancer. Aim: To evaluate whether quantitative faecal immunochemical testing performs better than commonly used high-risk symptoms based strategies for fast-tracking cancer referrals. Methods: We prospectively studied 1054 symptomatic patients referred for a colonoscopy who provided a sample for faecal immunochemical testing. The usefulness of faecal immunochemical testing and two current guidelines for urgent referral were compared for their efficacy in the detection of colorectal cancer and advanced neoplasia. Results: The guidelines detected 46.7% and 43.3% of cases of colorectal cancer while faecal haemoglobin concentration ≥15 ␮g Hb/g detected 96.7% of cases. The diagnostic accuracy of both the guidelines and faecal haemoglobin concentration ≥15 ␮g Hb/g for the detection of advanced neoplasia was: sensitivity 38.3%, 36.1%, 57.1% and specificity 71.8%, 69.5%, 86.6%, respectively. Male gender (OR 2.35; p < 0.001), age (1.34; p = 0.002), and faecal haemoglobin concentration ≥10 ␮g Hb/g (7.81; p < 0.001) were independent predictive factors of advanced neoplasia. Conclusions: A faecal immunochemical test based-strategy performs better than current high-risk symptoms based strategies for fast-tracking cancer referrals. A score that combines gender, age and a faecal immunochemical test could accurately estimate the risk of advanced neoplasia. © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

1. Introduction Colorectal cancer (CRC) is the second most common type of cancer and the second leading cause of cancer related death in Europe [1–3]. Prognosis depends strongly on tumour stage at diagnosis [1,3,4]. A delay in cancer diagnosis and its clinical implications have led several European health systems to develop referral systems for early diagnosis [1,5–7]. The recently updated CRC guidelines of the National Institute for Health and Care Excellence (NICE) and the

∗ Corresponding author at: Department of Gastroenterology, Hospital Universitari de Bellvitge, Feixa Llarga S/N, 08907 L’Hospitalet de Llobregat, Barcelona, Spain. Tel.: +34 932 607 500x2692/2826; fax: +34 93 2607883. E-mail address: [email protected] (J. Guardiola).

Scottish Intercollegiate Guidelines Network (SIGN) consider rectal bleeding associated with a change in bowel habit, the presence of an abdominal or rectal mass and/or the presence of iron deficiency anaemia (IDA) to be relevant symptoms for the selection of individuals for urgent referral [1,5]. The efficacy of these systems has been questioned extensively [8–11]. Scoring systems for the identification of symptomatic CRC that combine symptoms with other variables such as gender, age and family or personal history have been developed [12–15]. However, none of these strategies have obtained satisfactory results either because of their low diagnostic accuracy, their complexity or the difficulty of their implementation in clinical practice [12,14]. Colonoscopy is the accepted gold standard test for diagnosing CRC. Investigating digestive symptoms is recommended by several clinical guidelines [1,5]. However, it is unclear which

http://dx.doi.org/10.1016/j.dld.2015.05.004 1590-8658/© 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

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L. Rodríguez-Alonso et al. / Digestive and Liver Disease 47 (2015) 797–804

abdominal symptoms improve the diagnostic yield of colonoscopy in the detection of neoplasia [7,16–23]. Faecal immunochemical testing (FIT) provides high sensitivity in the detection of CRC and is a widely accepted strategy for CRC screening in the average-risk population [24,25]. However, the accuracy of FIT in the detection of advanced adenoma is limited. Multivariable risk models, including FIT and risk factors for CRC increase the accuracy of FIT-based CRC screening programmes [26,27]. Furthermore, there have been a number of important recent works on the use of FIT in symptomatic patients [28–32]. The idea that age and gender can be used along with FIT in risk scoring in symptomatic patients has also been suggested recently [29,33]. We hypothesized that quantitative FIT, either alone or in combination with signs and/or symptoms, may have a greater association with CRC or advanced neoplasia (AN) than high-risk symptoms. The objective of this study is therefore to evaluate whether a quantitative FIT based strategy performs better than commonly used high-risk symptoms based strategies (NICE and SIGN Guidelines) for fast tracking suspected cancer referrals. We also sought to create a risk score to stratify risk for advanced colorectal neoplasia in symptomatic adults.

patient was excluded from the study. One experienced technician performed the analyses of quantitative FIT. All tests were analyzed using the OC sensor MICRO desktop analyser (Eiken Chemical Co., Ltd., Tokyo, Japan). In our study, faecal haemoglobin concentration (f-Hb) of ≥10, ≥15 and ≥20 ␮g Hb/g faeces were taken as cut-off values. The test was identified with a barcode and patient data remained under the exclusive control of the investigators in order to preserve patient privacy and to ensure that the endoscopist and the technician were blind to FIT results. Colonoscopies were scheduled according to whether or not the patients fulfilled NICE or SIGN criteria and f-Hb (Fig. 1). All colonoscopies were performed by experienced endoscopists. Conscious sedation was administered using intravenous propofol and fentanyl. The dose of medication was titrated according to patient need and the duration of the procedure. The colonoscopy was considered complete if caecal intubation was achieved as demonstrated by the visualization of the ileocecal valve or the appendiceal orifice. Recorded data included the number, size and histology of polyps and the presence or absence of CRC. The study protocol was approved by the ethics committee of our institution and we obtained written informed consent from all patients. 2.2. Outcome measures

2. Methods 2.1. Study design and patients This is a prospective study comparing the diagnostic accuracy of the NICE and SIGN guidelines and the quantitative FIT for the detection of CRC with colonoscopy as the diagnostic gold standard. The study was carried out following the STARD guidelines (Supplementary Table S1) at the Endoscopy Department of Bellvitge University Hospital. The study included patients of more than 18 years of age referred for diagnostic colonoscopy between September 2011 and October 2012. We excluded patients referred for adenoma surveillance and postoperative surveillance of CRC. Hospitalized patients and those with a history of previous colectomy, IBD and polyp syndromes were also excluded. Patients with incomplete colonoscopies were included only if the cause was a stenosing neoplasm. Referrals originated from general practitioners and community gastroenterologists, as well as from the hospital environment. Eligible patients were invited to a consultation in which an exhaustive interview was performed by a gastroenterologist. An evaluation of signs, symptoms and CRC risk factors was recorded and a physical examination, including an abdominal and rectal examination, was performed (Supplementary Table S2). All patients with IDA (Hb ≤11 g/dl in men or ≤10 g/dl in postmenopausal women), a definitive palpable right-sided abdominal mass or a rectal mass, patients over the age of 40 years with rectal bleeding and diarrhoea for six week, and patients over the age of 60 years with rectal bleeding or diarrhoea for six weeks were considered to have fulfilled NICE criteria for urgent referral [1]. All patients with IDA (Hb ≤11 g/dl in men or ≤10 g/dl in postmenopausal women), palpable abdominal or rectal mass, patients over the age of 40 years with rectal bleeding and changes in bowel habit for six weeks and patients over the age of 40 years with isolated rectal bleeding were considered to have fulfilled SIGN criteria [5]. On the day of the consultation, the patient was given a specimen collection device (OC Sensor® Eiken Chemical Co., Ltd., Tokyo, Japan) and instructions were given on how to complete the test at home. Patients were instructed to store the sample in the refrigerator at

An urgent referral strategy for symptomatic patients with suspected colorectal cancer based on a quantitative immunochemical faecal occult blood test.

European health systems have developed referral guidelines for the selection of patients for the urgent investigation of suspected colorectal cancer...
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