Development and external validation of a faecal immunochemical test-based prediction model for colorectal cancer detection in symptomatic patients.

BACKGROUND: Risk prediction models for colorectal cancer (CRC) detection in symptomatic patients based on available biomarkers may improve CRC diagnosis. Our aim was to develop, compare with the NICE referral criteria and externally validate a CRC prediction model, COLONPREDICT, based on clinical and laboratory variables. METHODS: This prospective cross-sectional study included consecutive patients with gastrointestinal symptoms referred for colonoscopy between March 2012 and September 2013 in a derivation cohort and between March 2014 and March 2015 in a validation cohort. In the derivation cohort, we assessed symptoms and the NICE referral criteria, and determined levels of faecal haemoglobin and calprotectin, blood haemoglobin, and serum carcinoembryonic antigen before performing an anorectal examination and a colonoscopy. A multivariate logistic regression analysis was used to develop the model with diagnostic accuracy with CRC detection as the main outcome. RESULTS: We included 1572 patients in the derivation cohort and 1481 in the validation cohorts, with a 13.6 % and 9.1 % CRC prevalence respectively. The final prediction model included 11 variables: age (years) (odds ratio [OR] 1.04, 95 % confidence interval [CI] 1.02-1.06), male gender (OR 2.2, 95 % CI 1.5-3.4), faecal haemoglobin ≥20 µg/g (OR 17.0, 95 % CI 10.0-28.6), blood haemoglobin <10 g/dL (OR 4.8, 95 % CI 2.2-10.3), blood haemoglobin 10-12 g/dL (OR 1.8, 95 % CI 1.1-3.0), carcinoembryonic antigen ≥3 ng/mL (OR 4.5, 95 % CI 3.0-6.8), acetylsalicylic acid treatment (OR 0.4, 95 % CI 0.2-0.7), previous colonoscopy (OR 0.1, 95 % CI 0.06-0.2), rectal mass (OR 14.8, 95 % CI 5.3-41.0), benign anorectal lesion (OR 0.3, 95 % CI 0.2-0.4), rectal bleeding (OR 2.2, 95 % CI 1.4-3.4) and change in bowel habit (OR 1.7, 95 % CI 1.1-2.5). The area under the curve (AUC) was 0.92 (95 % CI 0.91-0.94), higher than the NICE referral criteria (AUC 0.59, 95 % CI 0.55-0.63; p < 0.001). On the basis of the thresholds with 90 % (5.6) and 99 % (3.5) sensitivity, we divided the derivation cohort into three risk groups for CRC detection: high (30.9 % of the cohort, positive predictive value [PPV] 40.7 %, 95 % CI 36.7-45.9 %), intermediate (29.5 %, PPV 4.4 %, 95 % CI 2.8-6.8 %) and low (39.5 %, PPV 0.2 %, 95 % CI 0.0-1.1 %). The discriminatory ability was equivalent in the validation cohort (AUC 0.92, 95 % CI 0.90-0.94; p = 0.7). CONCLUSIONS: COLONPREDICT is a highly accurate prediction model for CRC detection.

Fecal immunochemical test accuracy in familial risk colorectal cancer screening.

There is little information on fecal immunochemical test (FIT) in familial risk colorectal cancer (CRC) screening. Our study assesses FIT accuracy, number needed to scope (NNS) and cost to detect a CRC and an advanced neoplasia (AN) in this setting. We performed a multicentric, prospective, double-blind study of diagnostic tests on individuals with first-degree relatives (FDRs) with CRC submitted to screening colonoscopy. Two stool samples were collected and fecal hemoglobin in the first sample (FIT1) and the highest in both samples (FITmax) were determined. Areas under the curve (AUC) for CRC and AN as well as the best FIT1 and FITmax cutoff value for CRC were determined. At this threshold, NNS and the cost per lesion detected were calculated. A total of 595 individuals were included (one FDR > 60 years, 413; two FDR or one ≤ 60 years, 182). AN and CRC were found in 64 (10.8%) and six (1%) patients, respectively. For CRC diagnosis, FIT1 AUC was 0.96 [95% confidence interval (CI): 0.95-0.98] and FITmax AUC was 0.95 (95% CI: 0.93-0.97). For AN diagnosis, FIT1 and FITmax AUC were 0.74 (95% CI: 0.66-0.82). The best cutoff point for CRC was 115. At this threshold, the NNS to detect a CRC was 5.67 and 7.67, and the cost per CRC was 1,064€ and 1591.33€ on FIT1 and FITmax strategies, respectively. FIT shows high accuracy to detect CRC in familial CRC screening. Performing two tests does not improve diagnostic accuracy, but increases cost and NNS to detect a lesion.

Factors related to length of hospital admission in mild interstitial acute pancreatitis.

OBJECTIVES: to describe the clinical practice and the factors associated with length of hospital stay in mild acute pancreatitis. METHODS: we present a retrospective observational study that includes a series of patients admitted to our hospital between January 2007 and December 2009 due to mild acute pancreatitis. Baseline data, treatments and examinations were collected. Variables associated with the length of hospital were determined using a Cox proportional hazards model. RESULTS: 232 patients were included (median age 74.3 years, bedside index for severity in acute pancreatitis score 1, comorbidity Charlson score 1, 52.6 % male). 75.9 % were admitted to the gastroenterology department. Oral diet was reintroduced at 3 (0-11) days and 28 patients (12 %) were intolerant to oral re-feeding. Abdominal ultrasound, a magnetic resonance cholangiopancreatography, endoscopic ultrasound, a computed tomographic scan, and endoscopic retrograde cholangiopancreatography were performed in 92.2, 34.5, 9.5, 28.4 and 14.7 % of admissions, respectively. The length of hospital stay was 8 (1-31) days. The variables independently associated with length of admission were: Charlson index > or = 2 (hazard ratio-HR-1.4, 95 % confidence interval-CI- 1.06-1.84; p: 0.017), admission in gastroenterology department (HR 0.67, 95 % CI 0.49 to 0.93; p: 0.016), fasting period > or = 3 days (HR 1.37, 95 % CI 1.05-1.78; p: 0.02), intolerance to oral re-feeding (HR 1.8, 95 % CI 1.17-2.77; p: 0.007), performance of computed tomographic scan (HR 2.05, 95 % CI 1.49-2.82; p < 0.001), magnetic resonance cholangiopancreatography (HR 1.87, 95 % CI 1.42-2.49; p < 0.001) and endoscopic retrograde cholangiopancreatography (HR 2.23, 95 % CI 1.51-3.3; p < 0.001). CONCLUSIONS: the variables associated with length of hospital stay were comorbidity, department in charge, fasting period, food intolerance and complementary explorations.

Evaluation of the implementation of Galician Health Service indications and priority levels for colonoscopy in symptomatic patients: prospective, cross-sectional study.

BACKGROUND: the Galician Health Service established indications and priority levels (I = fast track, II = preferential, III = normal) for colonoscopy, according to the risk of colorectal cancer and significant colonic lesions detection with access from primary health care. Our aim is to show the results of the implementation. METHODS: we included colonoscopies requested in symptomatic patients from June to October 2012 in a prospective observational cross sectional study. We collected health care level (primary, secondary), priority, appropriateness to the established criteria, wait times (from colonoscopy application and initial consultation) and diagnostic yield for colorectal cancer and/or significant colonic lesion. We compared health care levels in priorities I and II. RESULTS: 425 colonoscopies were included (I = 221, II = 141, III = 63). The appropriateness rate to the protocol was 67.5 %. Priority levels were significantly associated to wait times (days) from application (I = 8.7 ± 8.9, II = 50 + or - 20.3, III = 80.2 + or - 32.2; p < 0.001) and initial consultation (I = 32.2 + or - 38, II = 74.5 + or - 44.2, III = 128.5 + or - 47.4; p < 0.001), and with colorectal cancer (I = 20.1 %, II = 19.1 %, III = 4.8 %, p < 0.001) and significant colonic lesion (I = 35.3 %, II = 34 %, III = 19 %, p = 0.002) detection rates. In priority I and II, 21.8 % of colonoscopies were requested from primary health care. Referral form primary health care reduced wait times from initial consultation to colonoscopy (primary = 29.3 + or - 26, secondary = 55.2 + or - 48.6, p < 0.001). Instead, colorectal cancer (OR 2.41, 95 % CI 1.31-4.42) and significant colonic lesion (OR 1.88, 95 % CI 1.13- 3.15) detection rate was increased. CONCLUSIONS: Galician Health Service priority levels are significantly associated with colorectal cancer and significant colonic lesion detection. Referrals to colonoscopy from primary health care reduce waiting times and increase diagnostic yield.

[Effect of the implementation of a program to improve referrals by primary care on appropriateness and wait times in endoscopic examinations]. / Efecto de la implantación de un programa de mejora de la capacidad resolutiva de atención primaria en la adecuación y la demora de las exploraciones endoscópicas.

INTRODUCTION: Within a program to improve referrals by primary care (PC) in Ourense (Spain), we implemented practice guidelines on dyspepsia and rectal bleeding. Our aim was to evaluate the reasons for referral to endoscopy, the appropriateness of these referrals, and wait times. MATERIAL AND METHODS: We performed a retrospective cohort study in the Ourense health area between February 2009 and January 2010. The endoscopies performed with the indications of dyspepsia and rectal bleeding requested directly from PC were compared with those referred initially to specialist care (SC). The reasons for the referral, the priority of the endoscopy, compliance with the protocol, endoscopic finding and the wait time from referral were gathered. RESULTS: During the period analyzed, 158 upper gastrointestinal endoscopies (SC: 121; PC: 37) and 243 colonoscopies (SC: 193; PC: 50) were performed with the indications of dyspepsia and rectal bleeding. Among endoscopies, 34.5% and 77.7% were requested with high priority from PC and SC, respectively (p<0.001). The criteria for referral were met in 86.5% of upper gastrointestinal endoscopies and in 82% of colonoscopies requested from PC. No differences were found in endoscopic findings. The median wait time from referral was lower in upper gastrointestinal endoscopy (PC: 105±5.5 days, SC: 174±17.8 days; p: 0.003) and colonoscopies (PC: 101±11.8 days, SC: 187±9.6 days; p<0.001) referred from PC. CONCLUSIONS: The use of the program for improved referrals by PC reduces wait times. The examinations requested complied with the indications.

[Liver abcess and biliary fistula as local complications of acute pancreatitis: approach and treatment]. / Absceso hepático y fístula biliar como complicaciones locales de una pancreatitis aguda: abordaje y tratamiento.

Acute pancreatitis is frequently associated with the development of local complications: collections, necrosis, pseudocysts and abdominal abscesses. Although the development of liver abscesses has been linked to bile duct obstruction or abdominal surgery in patients with chronic pancreatitis, there are few descriptions of liver abscesses associated with an episode of acute pancreatitis. We report the case of a 45-year-old man with a first episode of severe acute alcoholic pancreatitis, complicated with thrombosis of the right portal branch, liver abscess and intrahepatic biliary fistula. The approach and treatment are described.

Characteristics of adenomas detected by fecal immunochemical test in colorectal cancer screening.

BACKGROUND: Fecal immunochemical test (FIT) diagnostic accuracy for colorectal adenoma detection in colorectal cancer screening is limited. METHODS: We analyzed 474 asymptomatic subjects with adenomas detected on colonoscopy in two blinded diagnostic tests studies designed to assess FIT diagnostic accuracy. We determined the characteristics of adenomas (number, size, histology, morphology, and location) and the risk of metachronous lesions (according to European guidelines). Finally, we performed a logistic regression to identify those variables independently associated with a positive result. RESULTS: Advanced adenomas were found in 145 patients (75.6% distal and 24.3% only proximal to splenic flexure). Patients were classified as low (59.5%), intermediate (30.2%), and high risk (10.3%) according to European guidelines. At a 100-ng/mL threshold, FIT was positive in 61 patients (12.8%). Patients with advanced adenomas [odds ratio (OR), 8.8; 95% confidence interval (CI), 4.76-16.25], distal advanced adenomas (OR, 6.7; 95% CI, 1.9-8.8), high risk (OR, 20.1; 95% CI, 8.8-45.8), or intermediate risk lesions (OR, 6; 95% CI, 2.9-12.4) had more probabilities to have a positive test. The characteristics of adenomas independently associated were number of adenomas (OR, 1.22; 95% CI, 1.04-1.42), distal flat adenomas (OR, 0.44; 95% CI, 0.21-0.96), pedunculated adenomas (OR, 2.28; 95% CI, 1.48-3.5), and maximum size of distal adenomas (mm; OR, 1.24; 95% CI, 1.16-1.32). CONCLUSIONS: European guidelines classification and adenoma location correlates with the likelihood of a positive FIT result. IMPACT: This information allows us to understand the FIT impact in colorectal cancer prevention. Likewise, it should be taken into account in the development of new colorectal adenomas biomarkers.

Diagnostic accuracy of fecal immunochemical test in average- and familial-risk colorectal cancer screening.

BACKGROUND: There is little information about the fecal immunochemical test (FIT) in familial-risk colorectal cancer (CRC) screening. OBJECTIVES: The objective of this article is to investigate whether FIT diagnostic accuracy for advanced neoplasia (AN) differs between average and familial-risk (first-degree relative) patients. METHODS: A total of 1317 consecutive participants (595 familial) who collected one stool sample before performing a colonoscopy as a CRC screening test were included. FIT diagnostic accuracy for AN was evaluated with Chi-square test at a 20 µg hemoglobin/g of feces cut-off value. Finally, we determined which variables were independently related to AN. RESULTS: An AN was found in 151 (11.5%) patients. The overall accuracy was not statistically different between both cohorts for AN (88.4%, 91.7%; p = 0.051). At the cut-off stablished, differences in FIT sensitivity (31.1%, 40.6%; p = 0.2) or specificity (96.5%, 97.3%; p = 0.1) were not statistically significant. Finally, independent variables such as sex (male) (odds ratio (OR) 2.1, 95% confidence interval (CI) 1.4-3.1), age (50-65, >65 years) (OR 2.1, 95% CI 1.1-4.3; OR 2.7, 95% CI 1.2-6.1), previous colonoscopy (OR 0.4, 95% CI 0.2-0.9) and FIT ≥20 µg/g feces (OR 17.7, 95% CI 10.8-29.1) were associated with AN diagnosis. CONCLUSIONS: FIT accuracy for AN detection is equivalent in average and familial-risk CRC screening cohorts.

Factors associated with intolerance after refeeding in mild acute pancreatitis.

OBJECTIVES: This study aimed to describe the mode of refeeding, frequency of intolerance, and related factors in mild acute pancreatitis (AP). METHODS: We included all cases of mild AP between January 2007 and December 2009 in an observational, descriptive, and retrospective study. We analyzed demographic and etiological data, admission variables, treatment, refeeding mode, intolerance frequency, and treatment. Intolerance-related variables were determined using a Cox regression. RESULTS: Two-hundred thirty-two patients were included (median age, 74.3 years, bedside index for severity in AP score, 1). Oral diet was reintroduced at 3 days (range, 0-11 days) in 90.9% of cases with a liquid diet. Intolerance to refeeding appeared in 28 patients (12.1%) at a median time of 1 day (range, 0-14 days). Oral diet was reduced or suspended in 71.4%; analgesic and antiemetic drugs were required in 64% and 35.7% of patients, respectively. The variables independently associated with intolerance to refeeding were choledocholithiasis (hazard ratio [HR], 12.35; 95% confidence interval [CI], 2.98-51.19; P = 0.001), fasting time (HR, 1.33; 95% CI, 1.09-1.63; P = 0.005), refeeding with complete diet (HR, 4.93; 95% CI, 1.66-14.66; P = 0.04), length of symptoms before admission (HR, 1.004; 95% CI, 1.001-1.006; P = 0.012), and metamizole dose (HR, 1.11; 95% CI, 1.02-1.21; P = 0.014). CONCLUSIONS: Intolerance to refeeding is an infrequent event. We have identified several factors independently associated with intolerance.

[Referrals to a gastroenterology outpatient clinic from primary care: evaluation of two programs]. / Derivación a las consultas de gastroenterología desde atención primaria: evaluación de dos programas.

OBJECTIVES: To analyze the effect of implementing a high-resolution clinic (HRC) and an increasing resolution capacity program in primary care (IRCPPC) for referrals to a gastroenterology outpatient clinic from primary care and the resources used. METHODS: A retrospective and observational study based on a review of referral sheets and databases was performed. We analyzed the number and reason for referrals, delay times and resource consumption in two periods: before (first 4 months of 2007) and after (first 4 months of 2009) the launch of the IRCPPC and HRC. RESULTS: In the first and second periods, 881 and 1076 patients, respectively, referred from primary health care were evaluated in the gastroenterology clinic, with a decrease in the delay time in the second period (80.8 ± 64.34 days vs 36.1 ± 29.12 days, p < 0.001). The most frequent reasons for referral were dyspepsia (27.7%), high-risk of colorectal cancer (17.1%), disturbance of bowel rhythm (18.2%), abdominal pain (16%), and gastroesophageal reflux (11.2%), with no differences between the two periods. Although delay times until the first visit (10.8 ± 9.03 days vs 42.8 ± 28.67 days, p < 0.001) and until discharge (39.6 ± 80.65 days vs 128.6 ± 135.34 days, p < 0.001) were lower in referrals to the HRC, the number of visits (3.6 ± 2.20 vs 3.2 ± 1.95, p = 0.015) and the cost of referrals (592.7 ± 421.50 € vs 486.0 ± 309.66 €, p < 0.001) was higher. CONCLUSIONS: In the study period the number of referrals increased, while the delay time decreased. Although the HRC reduces delay times, it is associated with an increase in health resource use.

Risk factors associated with the development of ischemic colitis.

AIM: To ascertain the role of cardiovascular risk factors, cardiovascular diseases, standard treatments and other diseases in the development of ischemic colitis (IC). METHODS: A retrospective, case-control study was designed, using matched data and covering 161 incident cases of IC who required admission to our hospital from 1998 through 2003. IC was diagnosed on the basis of endoscopic findings and diagnostic or compatible histology. Controls were randomly chosen from a cohort of patients who were admitted in the same period and required a colonoscopy, excluding those with diagnosis of colitis. Cases were matched with controls (ratio 1:2), by age and sex. A conditional logistic regression was performed. RESULTS: A total of 483 patients (161 cases, 322 controls) were included; mean age 75.67 ± 10.03 years, 55.9% women. The principal indications for colonoscopy in the control group were lower gastrointestinal hemorrhage (35.4%), anemia (33.9%), abdominal pain (19.9%) and diarrhea (9.6%). The endoscopic findings in this group were hemorrhoids (25.5%), diverticular disease (30.4%), polyps (19.9%) and colorectal cancer (10.2%). The following variables were associated with IC in the univariate analysis: arterial hypertension (P = 0.033); dyslipidemia (P < 0.001); diabetes mellitus (P = 0.025); peripheral arterial disease (P = 0.004); heart failure (P = 0.026); treatment with hypotensive drugs (P = 0.023); angiotensin-converting enzyme inhibitors; (P = 0.018); calcium channel antagonists (P = 0.028); and acetylsalicylic acid (ASA) (P < 0.001). Finally, the following variables were independently associated with the development of IC: diabetes mellitus [odds ratio (OR) 1.76, 95% confidence interval (CI): 1.001-3.077, P = 0.046]; dyslipidemia (OR 2.12, 95% CI: 1.26-3.57, P = 0.004); heart failure (OR 3.17, 95% CI: 1.31-7.68, P = 0.01); peripheral arterial disease (OR 4.1, 95% CI: 1.32-12.72, P = 0.015); treatment with digoxin (digitalis) (OR 0.27, 95% CI: 0.084-0.857, P = 0.026); and ASA (OR 1.97, 95% CI: 1.16-3.36, P = 0.012). CONCLUSION: The development of an episode of IC was independently associated with diabetes, dyslipidemia, presence of heart failure, peripheral arterial disease and treatment with digoxin or ASA.