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Are we exposing patients with a mildly elevated faecal calprotectin to unnecessary investigations?

ABSTRACT: Faecal calprotectin (FC) is a non-invasive marker used to differentiate irritable bowel syndrome from inflammatory bowel disease (IBD). However, false positives are common. We sought to determine the diagnostic yield of investigation in patients presenting with new lower gastrointestinal (GI) symptoms and a mildly elevated FC (100-200 µg/g).Retrospective study of electronic patient records.Patients aged 16-50 years with new lower GI symptoms and an FC 100-200 µg/g were identified from our biochemistry laboratory database between September 2009 and 2011. Patients were excluded if they had a previous FC >200 µg/g, were taking non-steroidal anti-inflammatory drugs (NSAIDs), had IBD, positive stool cultures or 'alarm' symptoms.Secondary care gastroenterology clinics.161 patients (103 female patients) were identified. Mean age was 37.3 years with a mean FC of 147 µg/g. 398 endoscopic, radiological and histological investigations were undertaken in 141 patients (an average of 2.8 investigations per patient). 131 colonoscopies were performed with abnormalities in only 24 (18.3%). In patients with a macroscopically normal upper GI endoscopy and colonoscopy, the diagnostic yield of any further investigation was only 7.3%. The negative predictive value (NPV) of an FC 100-200 µg/g was 86.7% for any pathology and 97.5% for significant luminal pathology (IBD, advanced adenoma or colorectal carcinoma). After a mean follow-up of 172.4 weeks, IBD was the final diagnosis in only 4 (2.5%) of patients.In adult patients under 50 years old presenting with new lower GI symptoms, the NPV of an FC between 100 and 200 µg/g in excluding significant organic GI disease is high.

SUBMITTER: Seenan JP

PROVIDER: S-EPMC5369576 | biostudies-other | 2015 Jul

REPOSITORIES: biostudies-other

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Compliance with the faecal calprotectin test in patients with inflammatory bowel disease.

Project description:We investigated, for the first time, levels of compliance with faecal calprotectin test in inflammatory bowel disease patients.All consecutive adult inflammatory bowel disease patients having been prescribed an faecal calprotectin test between December 2014-July 2015 were included. At their next visit to the hospital, patients had to return a stool sample for the faecal calprotectin test and answer a simple questionnaire: 'Have you brought a stool sample? If not, why not? If so, did you encounter any difficulties when collecting the sample? Were you aware of faecal calprotectin before being asked to take the test?'.One hundred and one patients were included (50 men; 77 patients with Crohn's disease). The range age was 40 years (19-68). Eighty-nine patients were being treated with infliximab, 10 were on vedolizumab, and two were not being treated with a biologic. Thirty-seven patients (35%) had performed the faecal calprotectin test. Eighty-one patients (80%) had not been aware of faecal calprotectin before being asked to take the test. Of the 64 patients who did not take the test, the prime reasons for non-compliance were forgetfulness (n = 49, 76.6%), a lack of perceived benefit for the test (n = 7, 11%), constipation (n = 5, 7.8%), refusal to handle faeces (n = 2, 3.1%), and difficulty collecting the stool sample (n = 1, 1.5%).Only one-third of the patients performed the faecal calprotectin test. The main reason for non-compliance was forgetfulness. Our present results emphasise the need for better patient education on the importance of complying with faecal calprotectin testing and the future of faecal calprotectin testing at home.

| S-EPMC5548356 | biostudies-other

Faecal haemoglobin and faecal calprotectin as indicators of bowel disease in patients presenting to primary care with bowel symptoms.

Project description:ObjectiveIn primary care, assessing which patients with bowel symptoms harbour significant disease (cancer, higher-risk adenoma or IBD) is difficult. We studied the diagnostic accuracies of faecal haemoglobin (FHb) and faecal calprotectin (FC) in a cohort of symptomatic patients.DesignFrom October 2013 to March 2014, general practitioners were prompted to request FHb and FC when referring patients with bowel symptoms to secondary care. Faecal samples were analysed for haemoglobin (EIKEN OC-Sensor io) and calprotectin (BÜHLMANN Calprotectin ELISA). Patients triaged to endoscopy were investigated within 6?weeks. All clinicians and endoscopists were blind to the faecal test results. The diagnostic accuracies of FHb and FC for identification of significant bowel disease were assessed.Results1043 patients returned samples. FHb was detectable in 57.6% (median 0.4?µg/g, 95% CI 0.4 to 0.8; range 0-200). FC at 50?µg/g or above was present in 60.0%. 755 patients (54.6% women, median age 64?years (range 16-90, IQR 52-73)) returned samples and completed colonic investigations. 103 patients had significant bowel disease; the negative predictive values of FHb for colorectal cancer, higher-risk adenoma and IBD were 100%, 97.8% and 98.4%, respectively. Using cut-offs of detectable FHb and/or 200?µg/g FC detected two further cases of IBD, one higher-risk adenoma and no additional cancers.ConclusionsIn primary care, undetectable FHb is a good 'rule-out' test for significant bowel disease and could guide who requires investigation.

| S-EPMC5036251 | biostudies-literature

Mapping of Crohn's disease outcomes to faecal calprotectin levels in patients maintained on biologic therapy.

Project description:Faecal calprotectin (FC) is a sensitive marker of intestinal mucosal inflammation. The gold standard in Crohn's disease management is mucosal healing. The role of FC to support clinical practice in Crohn's disease is not yet defined.To determine, in patients with Crohn's disease established on biologic therapy: (1) the correlation between disease activity and FC levels, (2) whether FC can predict for relapse and (3) the sensitivity and specificity of the C-reactive protein (CRP) when compared with FC.In this retrospective, single-site study, Crohn's disease activity, clinical outcomes, FC and CRP of 76 patients established on biologic therapy were reviewed and mapped over time.Patients were mapped for a median of 34 months (IQR 21-57.5). FC levels were determined every 7 (4-13) months on average. Mean FC in quiescent disease was 105 μg/g (SEM 19); in mild disease, 282 (SEM 71); in moderate disease, 611 (SEM 80) and in severe disease, 1314 (SEM 224) (p<0.001). In asymptomatic patients who relapsed at 6 months, the optimal FC, with an area under the curve of 0.886 (p<0.001), was 357.5. In discriminating quiescent from active disease (FC>100 μg/g) the sensitivity and specificity of CRP were 0.48 (0.36-0.61) and 0.73 (0.6-0.85), and in mild from moderate or active disease (FC>250 μg/g), 0.60 (0.43-0.74) and (0.72 (0.60-0.82).FC is an accurate marker of Crohn's disease activity and predicts for relapse, thus providing the clinician time to optimise therapy. FC is a more sensitive marker of Crohn's disease activity than CRP.

| S-EPMC5369738 | biostudies-other

High negative predictive value of a normal faecal calprotectin in patients with symptomatic intestinal disease.

Project description:Calprotectin is a heat stable intracellular protein shed by neutrophils into the intestinal lumen in response to inflammation. Lack of specificity makes its role in the assessment of inflammatory bowel disease uncertain. However, the strength of faecal calprotectin testing may lie in its negative predictive value (NPV) rather than positive predictive value (PPV) of organic intestinal disease.To determine whether a normal faecal calprotectin in new patients with symptoms safely predicts for functional intestinal disease.To determine the predictive values of normal and raised faecal calprotectin by retrospective review of outcomes in consecutive primary care referrals into secondary care. Patients aged 16-60 years (mean age 41 years; 70% female patients) with intestinal symptoms were identified. 500 referrals had a normal faecal calprotectin and 130 had a raised result. 'Fast track' referrals were excluded. Outcome measures were the NPV of a normal faecal calprotectin and PPV of a raised faecal calprotectin.Normal faecal calprotectin had an NPV of 0.964 for excluding symptomatic organic intestinal disease. Significant incidental non-intestinal (3.6%) and intestinal (6.4%) diseases were also identified. Mean follow-up was 4.8 years with no diagnostic revisions. In the raised faecal calprotectin cohort, the PPV for organic intestinal disease was 0.7.A normal faecal calprotectin safely predicts for functional intestinal disease. It may represent a powerful screening tool for excluding organic intestinal disease in primary care. A prospective primary care based study is needed.

| S-EPMC5517244 | biostudies-other

Guidance on the interpretation of faecal calprotectin levels in children.

Project description:BackgroundFaecal calprotectin (FCP) is a powerful tool to predict inflammatory bowel disease (IBD) in patients with gastrointestinal symptoms. In the paediatric patient population, the reference value of < 50 μg/g and the influence of age on FCP levels result in a high number of redundant investigations and specialist referrals. We assessed paediatric FCP levels, their diagnostic value and corresponding referral pathways from primary and secondary care.MethodsWe analysed two cohorts from a precisely defined catchment area: one consisted of all FCPs measured in this area (n = 2788). The second cohort-a subset of the first cohort-consisted of FCP values and corresponding clinical data from children who were referred for possible IBD to our department (n = 373).ResultsIn the first cohort, 47% of FCP levels were > 50 μg/g, 15% were ≥ 250 μg/g. Children < 1y had significantly (p < 0.001) higher FCP than older children. In the second cohort, 6.7% of children with an FCP of < 250 μg/g (or 8.6% with an FCP of < 600 μg/g) had IBD-all featured symptoms suggestive of IBD (e.g. bloody diarrhoea, nocturnal abdominal pain, weight loss) or abnormal blood tests. 76% of patients in whom raised FCP (> 50 μg/g) was the sole reason for being referred for suspected IBD did not have IBD.ConclusionChildren with an FCP < 600 μg/g and without matching symptoms suggestive of IBD are unlikely to have IBD. A higher FCP reference value may provide cost-effective improvement that could avoid redundant investigations and specialist referrals. A guideline for specialist referrals is proposed.

| S-EPMC7877663 | biostudies-literature

Measurement of faecal calprotectin and lactoferrin in inflammatory bowel disease.

Project description:Crohn's disease and ulcerative colitis are chronic relapsing gastrointestinal conditions characterised by an influx of inflammatory cells to the affected gut mucosa. The mainstay of diagnosing and re-evaluating these conditions in clinical practice and research is by invasive serological, radiological, endoscopic and histological assessment. In clinical trials, disease activity is often evaluated using a combination of the above tests plus clinical indices such as the Crohn's Disease Activity Index and Ulcerative Colitis Activity Index. These tools rely on subjective assessment of symptoms and so, often, do not correlate with mucosal inflammation or mucosal healing, which may be the preferred therapeutic end point for long-term inflammatory bowel disease (IBD) management. The faecal biomarkers calprotectin and lactoferrin are neutrophil derived proteins that are stable in faeces and can be detected by quantitative ELISA in small stool samples. Concentrations of both are raised in patients with gastrointestinal mucosal inflammation. They provide a unique, inexpensive, non-invasive method of testing for active inflammatory disease. They can be used to screen for IBD and as a surrogate marker of mucosal healing they are useful in monitoring the response to therapeutic intervention or surgery. They may also predict the clinical course of the disease. This clinical review aims to discuss the current evidence, limitations and potential future uses of these biomarkers in IBD.

| S-EPMC3724198 | biostudies-other

Calprotectin and lactoferrin faecal levels in patients with Clostridium difficile infection (CDI): a prospective cohort study.

Project description:Measurement of both calprotectin and lactoferrin in faeces has successfully been used to discriminate between functional and inflammatory bowel conditions, but evidence is limited for Clostridium difficile infection (CDI). We prospectively recruited a cohort of 164 CDI cases and 52 controls with antibiotic-associated diarrhoea (AAD). Information on disease severity, duration of symptoms, 30-day mortality and 90-day recurrence as markers of complicated CDI were recorded. Specimens were subject to microbiological culture and PCR-ribotyping. Levels of faecal calprotectin (FC) and lactoferrin (FL) were measured by ELISA. Statistical analysis was conducted using percentile categorisation. ROC curve analysis was employed to determine optimal cut-off values. Both markers were highly correlated with each other (r2 = 0.74) and elevated in cases compared to controls (p<0.0001; ROC>0.85), although we observed a large amount of variability across both groups. The optimal case-control cut-off point was 148 mg/kg for FC and 8.1 ng/µl for FL. Median values for FL in CDI cases were significantly greater in patients suffering from severe disease compared to non-severe disease (104.6 vs. 40.1 ng/µl, p = 0.02), but were not significant for FC (969.3 vs. 512.7 mg/kg, p = 0.09). Neither marker was associated with 90-day recurrence, prolonged CDI symptoms, positive culture results and colonisation by ribotype 027. Both FC and FL distinguished between CDI cases and AAD controls. Although FL was associated with disease severity in CDI patients, this showed high inter-individual variability and was an isolated finding. Thus, FC and FL are unlikely to be useful as biomarkers of complicated CDI disease.

| S-EPMC4149523 | biostudies-literature

Impact of faecal calprotectin measurement on clinical decision-making in patients with Crohn's disease and ulcerative colitis.

Project description:BACKGROUND:Faecal calprotectin (FC) seems to be the best available biomarker for the detection of intestinal inflammation in patients with inflammatory bowel disease (IBD). The aim of this study is to clarify whether the measurement of FC has changed the number of ultrasound and endoscopic procedures, drug modifications, as well as FC re-measurements in IBD patients. METHODS:This retrospective study included 242 IBD patients with available FC values (case cohort) and 46 patients without an available FC value (control cohort). Clinical consequences such as carrying out abdominal ultrasound, endoscopy, drug modification or FC re-measurement at the next ambulatory presentation or during in-patient stay were collected. Statistical analysis was performed to determine the association between clinical decision-making and patient's characteristics, especially FC value. RESULTS:Overall, 192 (67%) clinical consequences were noted in both cohorts. In the case cohort 174 (91%) implications were noted compared to 18 (9%) in the control cohort (P < 0.001). In the case cohort, significantly more clinical consequences were detected in patients with Crohn's disease (CD) as well as in ulcerative colitis (UC) patients with a FC value > 250 mg/Kg than in patients with a value of ≤ 250 mg/Kg. In CD patients with high FC values significantly increased numbers of abdominal ultrasounds, endoscopies and FC re-measurements were noted. In UC patients with high FC values significantly increased numbers of abdominal ultrasounds, drug modifications and FC re-measurements were noted. CONCLUSION:Measurement of FC may alter physician's clinical decision-making in IBD patients beside other clinical and diagnostic parameters. Further prospective and survey studies are warranted to evaluate the influence of FC measurement in the daily clinical decision-making.

| S-EPMC6812761 | biostudies-literature

The combination of quantitative faecal occult blood test and faecal calprotectin is a cost-effective strategy to avoid colonoscopies in symptomatic patients without relevant pathology.

Project description:BackgroundFaecal occult blood test (FOBT) has demonstrated effectiveness in colorectal cancer (CRC) screening. Faecal calprotectin (FC) has proven efficient for evaluating activity in inflammatory bowel disease (IBD), but its value in CRC detection is less established. Most symptomatic patients have benign pathologies, but still undergo colonoscopy in many settings.AimsTo evaluate the diagnostic accuracy and cost-effectiveness of the combination of FOBT plus FC in symptomatic patients.MethodsPatients who completed colonic investigations and returned stool samples, on which FOBT and FC were performed, were recruited prospectively. CRC, advanced adenoma, IBD and angiodysplasia were considered as relevant pathologies.ResultsA total of 404 patients were included, of whom 87 (21.5%) had relevant pathologies. Sensitivity and specificity were 50.6% and 69.6% for FOBT, 78.2% and 54.4% for FC. Negative predictive value (NPV) was 90.1% for FC and 86.9% for FOBT. NPV for the combination of FOBT and FC was 94.1%, with a sensitivity and specificity of 88.5% and 50.3%. The area under ROC (receiver operator curve) (AUC) was 0.741 for FOBT, 0.736 for FC and 0.816 for the combination. The total cost for visits and procedures was €233,016 (€577/patient). Using a combination of FOBT and FC as pre-endoscopic tool allows colonoscopies to be reduced by 39.4%, reducing total costs by 20.5%.ConclusionThe combination of FOBT and FC has a better diagnostic accuracy compared with each test alone. Performing both tests before colonoscopy is a less costly and more effective strategy, reducing unnecessary procedures and complications.

| S-EPMC7235671 | biostudies-literature

Diagnostic yield of endoscopy in patients with abdominal complaints: incremental value of faecal calprotectin on guidelines of appropriateness.

Project description:BackgroundEuropean Panel on the Appropriateness of Gastrointestinal Endoscopy (EPAGE) criteria have been developed to increase diagnostic yield, but their predictive value is limited. We investigated the incremental diagnostic value of faecal calprotectin to EPAGE criteria.MethodsIn a post-hoc analysis of a prospective study, EPAGE criteria were applied to 298 of 575 (51.8%) patients who had undergone esophagogastroduodenoscopy (EGD), colonoscopy or both for abdominal complaints at the Division of Gastroenterology & Hepatology at the University Hospital Basel in Switzerland. Faecal calprotectin was measured in stool samples collected within 24 hours before the investigation using an enzyme-linked immunosorbent assay. Final endoscopic diagnoses were blinded to calprotectin values.ResultsOf 149 EGDs and 224 colonoscopies, 17.6% and 14.7% respectively were judged inappropriate by EPAGE criteria. Appropriate or uncertain indications revealed more endoscopic findings in both EGD (46.3% vs. 23.1%, P = 0.049) and colonoscopy (23.6% vs. 6.1%, P = 0.041) than inappropriate indications. Median calprotectin levels were higher (81.5 ?g/g, interquartile range 26-175, vs. 10 ?g/g, IQR 10-22, P < 0.001) and testing was more often positive (>50 ?g/g) in patients with endoscopic findings, both in EGD (58.2% vs. 33.0%, P = 0.005) and in colonoscopy (57.3% vs. 7.4%, P < 0.001). The use of faecal calprotectin in addition to EPAGE criteria improved the risk reclassification of patients by endoscopic findings. The calculated net reclassification index was 37.8% (P = 0.002) for EGD and 110.9% (P <0.001) for colonoscopy, thus improving diagnostic yield to 56.8% and 70.2%, respectively.ConclusionsThe use of faecal calprotectin in addition to EPAGE criteria improved diagnostic yield in patients with abdominal complaints.

| S-EPMC4021405 | biostudies-literature

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