RESUMEN
OBJECTIVE: Limited data exist on attendance and additional yield of 2-sample faecal immunochemical testing (FIT) screening during multiple rounds. We therefore conducted a population-based colorectal cancer screening trial comparing attendance and yield of repeated 1-sample and 2-sample FIT screenings. DESIGN: Two randomly selected groups of average-risk subjects aged 50-74â years were invited for two rounds of either 1-sample (n=5007) or 2-sample (n=3197) FIT (OC-sensor Micro) screening. The test was considered positive if at least one sample was positive (cut-off 50â ng/mL; 10â µg haemoglobin/g). RESULTS: The cumulative attendance rate was similar for repeated 1-sample and 2-sample FIT screenings (1-sample FIT: 68.1%; 2-sample FIT: 67.1%, p=0.368). The positivity rate in the second round was lower for 1-sample FIT (6.2%, 95% CI 5.4% to 7.2%) than for 2-sample FIT (8.4%, 95% CI 7.1% to 9.8%, p=0.007), whereas the detection rate of advanced neoplasia (AN, 1-sample FIT: 1.9%, 95% CI 1.2% to 2.2%; 2-sample FIT: 1.7%, 95% CI 1.2% to 2.5%, p=0.861) and the positive predictive value (1-sample FIT: 32%, 95% CI 24% to 40%; 2-sample FIT: 21%, 95% CI 15% to 29%, p=0.075) did not differ. After two rounds of screening, the cumulative diagnostic yield of AN for 1-sample FIT was 29.3 per 1000 invitees, compared with 34.0 for 2-sample FIT (p=0.241). CONCLUSIONS: Using 2-sample FIT instead of 1-sample FIT does not result in a higher detection rate of AN in the second round of repeated FIT screening. Furthermore, both strategies lead to a similar yield of AN over two rounds. These findings imply that 1-sample FIT screening is preferred over 2-sample FIT screening.
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Neoplasias Colorrectales/diagnóstico , Detección Precoz del Cáncer/métodos , Detección Precoz del Cáncer/estadística & datos numéricos , Heces/química , Cooperación del Paciente/estadística & datos numéricos , Anciano , Hemoglobinas/análisis , Humanos , Inmunoquímica , Persona de Mediana Edad , Valor Predictivo de las PruebasRESUMEN
BACKGROUND & AIMS: Fecal immunochemical tests (FITs) are used widely in colorectal cancer screening. Programs use the same fecal hemoglobin threshold for colonoscopy referral for men and women, but it is unclear whether FIT performs equally in both sexes. We therefore assessed FIT performance in men and women. METHODS: A prospective cohort study was performed, in which a total of 10,008 average-risk subjects (age, 50-74 y) were invited for first-round screening and 8316 average-risk subjects (age, 51-74 y) were invited for second-round screening with a single FIT. Subjects with a hemoglobin (Hb) level of 10 µg hemoglobin (Hb)/g (or ≥50 ng/mL) feces or higher were referred for colonoscopy. The test characteristics were assessed by sex for a range of FIT cut-off values. RESULTS: In total, 59.8% of men and 64.6% of women participated in the first round (P < .001). At a cut-off level of 10 µg Hb/g feces, the positivity rate was significantly higher among men (10.7%) compared with women (6.3%; P < .001) in the first round. The detection rate of advanced neoplasia was 4.4% for men and 2.2% for women (P < .001) in the first round. The positive predictive value for advanced neoplasia in the first round was 42% for men and 37% for women (P = .265). A significantly higher false-positive rate in men (6.3%) than in women (4.1%; P < .001) was found. Similar differences in these test characteristics were seen in the second round. CONCLUSIONS: At a cut-off level of 10 µg Hb/g feces the FIT positivity rate was higher in men, reflected by both a higher detection rate and a higher false-positive rate. The use of the same cut-off value in men and women in FIT screening is recommended based on equal test performance in terms of positive predictive value.
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Técnicas de Laboratorio Clínico/métodos , Neoplasias Colorrectales/diagnóstico , Pruebas Diagnósticas de Rutina/métodos , Heces/química , Hemoglobinas/análisis , Tamizaje Masivo/métodos , Anciano , Femenino , Humanos , Inmunoensayo/métodos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores SexualesRESUMEN
OBJECTIVE: The sensitivity and specificity of a single faecal immunochemical test (FIT) are limited. The performance of FIT screening can be improved by increasing the screening frequency or by providing more than one sample in each screening round. This study aimed to evaluate if two-sample FIT screening is cost-effective compared with one-sample FIT. DESIGN: The MISCAN-colon microsimulation model was used to estimate costs and benefits of strategies with either one or two-sample FIT screening. The FIT cut-off level varied between 50 and 200 ng haemoglobin/ml, and the screening schedule was varied with respect to age range and interval. In addition, different definitions for positivity of the two-sample FIT were considered: at least one positive sample, two positive samples, or the mean of both samples being positive. RESULTS: Within an exemplary screening strategy, biennial FIT from the age of 55-75 years, one-sample FIT provided 76.0-97.0 life-years gained (LYG) per 1000 individuals, at a cost of 259,000-264,000 (range reflects different FIT cut-off levels). Two-sample FIT screening with at least one sample being positive provided 7.3-12.4 additional LYG compared with one-sample FIT at an extra cost of 50,000-59,000. However, when all screening intervals and age ranges were considered, intensifying screening with one-sample FIT provided equal or more LYG at lower costs compared with two-sample FIT. CONCLUSION: If attendance to screening does not differ between strategies it is recommended to increase the number of screening rounds with one-sample FIT screening, before considering increasing the number of FIT samples provided per screening round.
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Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/economía , Detección Precoz del Cáncer/economía , Detección Precoz del Cáncer/métodos , Heces/química , Inmunohistoquímica/economía , Sangre Oculta , Anciano , Colonoscopía/economía , Neoplasias Colorrectales/epidemiología , Análisis Costo-Beneficio , Humanos , Incidencia , Tamizaje Masivo/economía , Persona de Mediana Edad , Países Bajos/epidemiología , Valor Predictivo de las Pruebas , Sensibilidad y Especificidad , Factores de TiempoRESUMEN
OBJECTIVE: Colorectal cancer screening by means of faecal immunochemical tests (FITs) requires successive screening rounds for an optimal preventive effect. However, data on the influence of the length of the screening interval on participation and diagnostic yield are lacking. Repeated FIT screening was therefore performed in a population-based trial comparing various repeat intervals. DESIGN: 7501 Dutch individuals aged 50-74 years were randomly selected and invited for two 1-sample FIT screening rounds (haemoglobin (Hb) concentration ≥ 50 ng/ml, corresponding to 10 µg Hb/g faeces) with intervals of 1 (group I), 2 (group II) or 3 years (group III). RESULTS: In group I, participation was 64.7% in the first screening round and 63.2% in the second. The corresponding percentages for groups II and III were 61.0% vs 62.5% and 62.0% vs 64.0%. Triennial screening resulted in a higher participation rate in the second screening round compared with annual screening (p=0.04). The overall positivity rate in the second screening round was significantly lower compared with the first round (6.0% vs 8.4%; OR 0.69, 95% CI 0.58 to 0.82) and did not depend on interval length (p=0.23). Similarly, the overall detection rate of advanced neoplasia was significantly lower in the second round compared with the first screening round (1.9% vs 3.3%; OR 0.57, 95% CI 0.43 to 0.76) and also did not depend on interval length (p=0.62). The positive predictive value of the FIT did not significantly change over time (41% vs 33%; p=0.07). CONCLUSION: The total number of advanced neoplasia found at repeat FIT screening is not influenced by the interval length within a range of 1-3 years. Furthermore, there is a stable and acceptably high participation in the second screening round. This implies that screening intervals can be tailored to local resources.
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Adenoma/diagnóstico , Neoplasias Colorrectales/diagnóstico , Heces/química , Hemoglobinas/análisis , Sangre Oculta , Anciano , Detección Precoz del Cáncer/métodos , Estudios de Seguimiento , Humanos , Inmunoquímica , Tamizaje Masivo , Persona de Mediana Edad , Sensibilidad y Especificidad , Factores de TiempoRESUMEN
OBJECTIVES: Fecal immunochemical tests (FIT) are preferred over guaiac-based fecal occult blood testing as colorectal cancer (CRC) screening tool. However, hemoglobin (Hb) degradation over time may influence FIT outcome. We therefore evaluated the effect of sample return time on FIT performance characteristics in a population-based CRC screening trial. METHODS: A representative random sample of the Dutch population (n=17,677), aged 50-74 years, was invited for FIT screening (OC-Sensor Micro; cutoff ≥ 50 ng Hb/ml). Sample return time was defined as the interval in days between fecal sampling and FIT laboratory delivery. Moreover, a random sample of positive FITs were selected to be stored at room temperature and re-tested every 3-4 days. RESULTS: In total, 8,958 screenees fulfilled our inclusion criteria. The mean sample return time was 3 days (± 3). Overall, 792 screenees (8.8%) had a positive test. Between the sample return time groups, the positivity rate (PR) varied between 7.7 and 9.0%. No statistically significant associations were found between PR or detection rate (DR) and the different sample return time groups (P value=0.84 and 0.76, respectively). For the laboratory experiment, 71 positive FITs were stored at room temperature and re-tested with standard intervals. The mean daily fecal Hb decrease was 5.88% per day (95% confidence interval 4.78-6.96%). None of the positive FITs became negative before 10 days after fecal sampling. CONCLUSIONS: This population-based CRC screening trial demonstrates that both the PR and DR of FITs do not decrease with prolonged sample return times up to 10 days. This means that a delay in sending the FIT back to the laboratory, of up to at least 1 week, does not necessitate repeat sampling in case of a negative test result. These data support the use of FIT-based screening as a reliable tool for nationwide CRC screening programs.
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Neoplasias Colorrectales/diagnóstico , Heces/química , Hemoglobinas/análisis , Manejo de Especímenes/normas , Anciano , Femenino , Humanos , Inmunoquímica , Masculino , Persona de Mediana Edad , Factores de TiempoRESUMEN
BACKGROUND & AIMS: The fecal immunochemical test (FIT) is superior to the guaiac-based fecal occult blood test in detecting neoplasia. There are not much data on the optimal number of FITs to perform. We conducted a population-based trial to determine attendance and diagnostic yield of 1- and 2-sample FIT screening. METHODS: The study included 2 randomly selected groups of subjects aged 50-74 years (1-sample FIT, n=5007; 2-sample FIT, n=3197). The 2-sample group was instructed to collect fecal samples on 2 consecutive days. Subjects were referred for colonoscopy when at least 1 sample tested positive (≥50 ng hemoglobin/mL). RESULTS: Attendance was 61.5% in the 1-sample group (2979 of 4845; 95% confidence interval, 60.1%-62.9%) and 61.3% in the 2-sample group (1875 of 3061; 95% confidence interval, 59.6%-63.0%; P=.84). In the 1-sample group 8.1% tested positive, and in the 2-sample group 12.8% had at least 1 positive test outcome and 5.0% had 2 positive test outcomes (P<.05). When the mean from both test results in the 2-sample group was used, 10.1% had a positive test outcome (P<.05). The detection rates for advanced neoplasia were 3.1% in the 1-sample group, 4.1% in the 2-sample group with at least 1 positive test outcome, 2.5% when both test results were positive, and 3.7% among subjects with the mean from both test results being positive. CONCLUSIONS: There is no difference in attendance for subjects offered 1- or 2-sample FIT screening. The results allow for the development of efficient FIT screening strategies that can be adapted for local colonoscopy capacities, rather than varying the cut-off value in a 1-sample strategy.
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Técnicas de Laboratorio Clínico/métodos , Heces/química , Hemorragia Gastrointestinal/diagnóstico , Hemoglobinas/análisis , Inmunoquímica/métodos , Tamizaje Masivo/métodos , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Distribución Aleatoria , Sensibilidad y EspecificidadRESUMEN
The buried bumper syndrome (BBS) is a rare complication of percutaneous endoscopic gastrostomy (PEG). Hereby the internal PEG bumper is overgrown by hypertrophic gastric mucosa and embedded into the gastric wall. Most often an endoscopic approach to remove the bumper is successful. If not, an operative removal of the plate is necessary. In this paper, we present a case of a patient in whom a BBS was diagnosed. Besides the therapeutic options to treat a BBS, in this paper we want to focus on the prevention of this complication. Consideration needs to be given as to how long after the procedure should it be loosened to prevent BBS. The distance a PEG tube is advanced and whether it should be rotated is crucial in order to prevent BBS.
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Migración de Cuerpo Extraño/terapia , Gastrostomía/efectos adversos , Complicaciones Posoperatorias/terapia , Adulto , Migración de Cuerpo Extraño/diagnóstico , Gastroscopía , Humanos , Masculino , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/etiología , Estómago/cirugía , SíndromeRESUMEN
BACKGROUND: Faecal immunochemical test (FIT)-based colorectal cancer screening requires successive rounds for maximum preventive effect. Advanced neoplasia can bleed intermittently and thus might be missed by single faecal sampling. Few studies have been done on two sample FIT (2-FIT) screening over multiple rounds. Therefore, we compared multiple rounds of one sample FIT (1-FIT) with 2-FIT screening with respect to participation, positive predictive value (PPV), diagnostic yield, and interval colorectal cancer. METHODS: In this population-based study, a random selection of asymptomatic individuals aged 50-74 years in the Rotterdam-Rijnmond region, Netherlands, were invited by post for four rounds (every 2 years) of 1-FIT or 2-FIT screening. Key exclusion criteria were a history or colorectal cancer or inflammatory bowel disease, colon imaging in the previous 2 years, and life expectancy of less than 5 years. Per round, invitees received one or two FITs to sample either one or two consecutive bowel movements. OC-Sensor Micro (Eiken Chemical Co., Ltd, Japan) FITs were used by all participants, except the fourth round of screening for the 1-FIT cohort, for which participants used either an OC-Sensor or a FOB-Gold (Sentinel Diagnostics, Milan, Italy). A faecal haemoglobin cutoff concentration of 10 µg/g of faeces in at least one test was used for referral for colonoscopy. FINDINGS: Between 2006 and 2015, of 10â008 invited individuals for the 1-FIT cohort, 9787 were eligible for inclusion, of whom 7310 participated at least once in four successive rounds. Of 3197 invited individuals for the 2-FIT cohort, 3131 were eligible for inclusion, and 2269 participated at least once in four successive rounds. In the 1-FIT screening cohort, 74·7% (7310 of 9787) of invitees participated at least once versus 72·5% (2269 of 3131) of invitees in the 2-FIT cohort (p=0·013). Among participants who participated at least once, the cumulative positivity rate over four rounds was 19·2% (1407 of 7310) for the 1-FIT cohort versus 28·5% (647 of 2269) for the 2-FIT cohort (p<0·0001). The cumulative PPV for advanced neoplasia was 33·0% (432 of 1308 colonoscopies) for the 1-FIT cohort versus 24·2% (147 of 607 colonoscopies) for the 2-FIT cohort (p<0·0001). The cumulative diagnostic yield of advanced neoplasia among invited individuals was 4·4% (432 of 9787) for 1-FIT versus 4·7% (147 of 3131) for 2-FIT screening (p=0·46)). FIT interval colorectal cancers were detected in eight (0·1%) of 7310 participants in the 1-FIT cohort and two (0·1%) of 2269 with 2-FIT screening (p=1·00). INTERPRETATION: Four rounds of 2-FIT screening with a low faecal haemoglobin cutoff level did not result in a significant increase in diagnostic yield or a decrease in interval colorectal cancers compared with 1-FIT, despite higher colonoscopy demand. Therefore, 1-FIT colorectal cancer screening programmes should be preferred. FUNDING: None.
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Neoplasias Colorrectales/diagnóstico , Detección Precoz del Cáncer/métodos , Detección Precoz del Cáncer/estadística & datos numéricos , Sangre Oculta , Anciano , Estudios de Cohortes , Colonoscopía/estadística & datos numéricos , Femenino , Hemoglobinas/análisis , Humanos , Inmunoquímica , Masculino , Persona de Mediana Edad , Aceptación de la Atención de Salud/estadística & datos numéricos , Valor Predictivo de las PruebasRESUMEN
INTRODUCTION: The aim of this study was to evaluate information provided on pregnancy, personal decision making, disease course, and outcome of pregnancy from a patient's perspective in a population of patients with inflammatory bowel disease (IBD) attending two general hospitals. PATIENTS AND METHODS: A questionnaire was sent to all female patients with IBD in two general hospitals in the Netherlands. The questionnaire comprised four sections: (i) demographic data and medication use (ii) details on previous pregnancies and reasons for not becoming pregnant, (iii) outcome of pregnancies before IBD diagnosis, and (iv) outcome of pregnancies after IBD diagnosis. If necessary, medical records were reviewed to verify responses or for further medical details. RESULTS: In total, 385 women returned the questionnaire, 501 completed pregnancies were reported, and 113 women had never been pregnant. In 272 women with at least one pregnancy, 334 pregnancies occurred before IBD diagnosis, 157 after IBD diagnosis, and in 10 cases, IBD was diagnosed during pregnancy. Medication for IBD was used in 67% of pregnancies after IBD diagnosis, mainly 5-ASA preparations (54%). Women with ulcerative colitis experienced more IBD-related complaints during pregnancy compared with women with Crohn's disease (25 vs. 14%, P=0.016). Additional medication (n=21) or surgery (n=2) for IBD during pregnancy was indicated in 14% of cases. Most women reported an uneventful pregnancy course (79%). Preterm birth occurred in 13% of pregnancies. CONCLUSION: Pregnancy in women with IBD seen in a general hospital can be managed with a good outcome. Step-up therapy is needed in a minority of cases, and severe complications are rare.
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Antiinflamatorios/uso terapéutico , Toma de Decisiones Clínicas , Colitis Ulcerosa/terapia , Servicios de Salud Comunitaria , Enfermedad de Crohn/terapia , Procedimientos Quirúrgicos del Sistema Digestivo , Servicios de Planificación Familiar , Fármacos Gastrointestinales/uso terapéutico , Complicaciones del Embarazo/terapia , Adulto , Antiinflamatorios/efectos adversos , Colitis Ulcerosa/diagnóstico , Colitis Ulcerosa/inmunología , Enfermedad de Crohn/diagnóstico , Enfermedad de Crohn/inmunología , Procedimientos Quirúrgicos del Sistema Digestivo/efectos adversos , Sustitución de Medicamentos , Femenino , Fármacos Gastrointestinales/efectos adversos , Hospitales Generales , Humanos , Persona de Mediana Edad , Países Bajos , Embarazo , Complicaciones del Embarazo/diagnóstico , Complicaciones del Embarazo/inmunología , Resultado del Embarazo , Nacimiento Prematuro , Estudios Retrospectivos , Factores de Riesgo , Encuestas y Cuestionarios , Adulto JovenRESUMEN
A 45-year-old Turkish man presented with a chronic hepatitis B virus infection, a nodular lesion in the liver and a highly elevated serum alpha-foetoprotein (AFP) concentration. Ultrasound and MRI showed multiple focal liver lesions and a thickened wall of the gastro-oesophageal junction. Biopsies taken from both sites showed stomach type mucosa with a poorly differentiated adenocarcinoma and AFP positive tumour cells. The diagnosis was hepatoid adenocarcinoma of the stomach. The authors' conclusion is that an elevated serum AFP concentration in a patient with chronic hepatitis B and a nodular lesion in the liver is not diagnostic for a hepatocellular carcinoma. AFP measurement should not be used as a screening method for this type of cancer.
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Adenocarcinoma/metabolismo , Adenocarcinoma/patología , Neoplasias Gástricas/metabolismo , Neoplasias Gástricas/patología , alfa-Fetoproteínas/biosíntesis , Carcinoma Hepatocelular/patología , Carcinoma Hepatocelular/secundario , Resultado Fatal , Humanos , Neoplasias Hepáticas/patología , Neoplasias Hepáticas/secundario , Masculino , Persona de Mediana EdadRESUMEN
INTRODUCTION: Changes in the expression of mucin genes in the esophageal mucosa associated with uncomplicated gastro-esophageal reflux disease have not been evaluated even though such changes could be associated with reflux-induced mucosal damage. We therefore sought to identify reflux-induced changes in mucin gene expression using a cell line and biopsies from the esophageal mucosa in patients with and without reflux. METHODS: MUC-1, MUC-3, MUC-4, and MUC-5AC gene expressions were investigated in the HET-1A cell line following exposure to acid (pH 4) and/or bile (120 muM of a bile salt milieu), and in esophageal mucosal biopsies from controls, subjects with non-erosive gastro-esophageal reflux, and subjects with reflux associated with ulcerative esophagitis (erosive). The mucosal biopsies were also evaluated for IL-6 mRNA expression (inflammatory marker) and CK-14 mRNA expression (mucosal basal cell layer marker). Gene expression was determined using real-time reverse transcriptase-polymerase chain reaction analysis. RESULTS: In the cell line studies, there were differences in mRNA levels for all of the evaluated mucins following treatment with either acid or the acid and bile combination. In the studies which evaluated tissue specimens, IL-6 and CK-14 mRNA levels increased according to degree of reflux pathology. The expression of MUC-1 and MUC-4 in mucosa from patients with erosive reflux was lower than in subjects without reflux and in patients with non-erosive reflux, whereas the expression of MUC-3 and MUC-5AC was increased (although these differences did not reach significance at p < 0.05). When mRNA expression data for tissue samples from all groups were combined, significant correlations were identified between IL-6 vs. CK-14 and IL-6 vs. MUC-3, MUC-3 vs. CK-14 and MUC-3 vs. MUC-5AC, and for MUC-1 vs. MUC-5AC. The correlation between IL-6 and CK-14 was also significant within the control and non-erosive reflux groups. The correlation between IL-6 and MUC-3 was significant within the control and erosive reflux groups, and the correlation between MUC-1 and MUC-5AC was significant within the erosive reflux group. CONCLUSIONS: The results of this study suggest that the profile of mucin expression in the esophageal mucosa is influenced by the pH and composition of the gastro-esophageal reflux. Further work should explore the response of these genes to acid and bile reflux, and their role in the etiology of mucosal damage in gastro-esophageal reflux.