Colon capsule endoscopy in clinical practice: lessons from a national 5-year observational prospective cohort.

Background and study aims Colon capsule endoscopy (CCE) has been proposed as an alternative to colonoscopy for screening patients at average risk of colorectal cancer (CRC). A prospective national cohort was developed to assess relevance of CCE in real-life practice and its short- and long-term impacts on clinical management. Patients and methods All patients who underwent a CCE in France were prospectively enrolled from January 2011 to May 2016 and reached annually by phone until May 2017. All CCE and colonoscopy reports were systematically collected. Results During the study period, 689 CCEs were analyzed from 14 medical centers. Median follow-up time was 35 months [IQR: 12-50]. Indication for CCE was mainly for elderly patients (median age: 70 years, IQR: [61-79]) due to anesthetic or colonoscopy contraindication (n = 307; 44.6 %). Only 337 CCEs (48.9 %) were both complete and with adequate bowel preparation. Advanced neoplasia (adenoma with high-grade dysplasia or CRC) was diagnosed following 32 CCEs (4.6 %). Among patients who underwent colonoscopy or therapeutic surgery following CCE, 18.8 % of all advanced neoplasias (6/32) had not been diagnosed by CCE mainly due to technical issues. Performing a colonoscopy in the case of significant polyps or insufficient bowel cleansing or after an incomplete CCE allowed the diagnosis of 96.9 % of all identified advanced neoplasias (31/32). Conclusions Outside the scope of academic trials, improvement is needed to increase the reliability of CCE as less than half were considered optimal i. e. complete with adequate bowel cleansing. Most of missed colonic advanced neoplasia were due to incomplete CCE with distal neoplasia location.

Low FODMAPs diet or usual dietary advice for the treatment of refractory gastroesophageal reflux disease: An open-labeled randomized trial.

BACKGROUND: The low FODMAPs (fermentable oligo-, di-, monosaccharides, and polyols) diet improves lower gastrointestinal symptoms. Patients suffering from proton pump inhibitor (PPI) refractory gastroesophageal reflux disease (GERD) have limited treatment options. We investigated the efficacy of a low FODMAPs diet in patients with PPI refractory GERD. METHODS: This multicenter, randomized, open-label study compared the efficacy of a 4-week low FODMAPs diet and usual dietary advice (ie, low-fat diet and head of bed elevation) in patients with symptomatic PPI refractory GERD, defined by a Reflux Disease Questionnaire (RDQ) score >3 and abnormal pH-impedance monitoring on PPIs. The primary endpoint was the percentage of responders (RDQ ≤3) at the end of the diet. RESULTS: Thirty-one patients (55% women, median age 45 years) were included, 16 randomized in the low FODMAPs diet group and 15 in the usual dietary advice group. Adherence to the assigned diet was good, with a significant difference in the FODMAPs intake per day between the low FODMAPs diet (2.5 g) and the usual dietary advice group (13 g) (p < 0.001). There was no difference in response rates (RDQ score ≤3) between the low FODMAPs diet (6/16, 37.5%) and usual dietary advice (3/15, 20%) groups (p = 0.43). Total RDQ score and dyspepsia subscore decreased significantly over time in both groups (p = 0.002), with no difference according to the assigned diet group (p = 0.85). CONCLUSION: Low FODMAPs diet and usual dietary advice have similar but limited beneficial effects on symptoms in patients with PPI refractory GERD.

Randomised clinical trial: oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn.

BACKGROUND: Oesophageal radiofrequency reduces use of proton pump inhibitors (PPIs) in patients with gastro-oesophageal reflux disease responding to PPIs. AIM: To determine the efficacy of oesophageal radiofrequency in patients with PPI-refractory heartburn. METHODS: A randomised, double-blind, sham-controlled multicentre study was designed to assess the efficacy of oesophageal radiofrequency in PPI non-responding patients with heartburn. Patients had moderate-to-severe heartburn defined by at least 3 occurrences a week, and not improved by continuous PPI treatment. The primary endpoint was clinical success at week 24, defined by intake of less than 7 PPI doses over the 2 preceding weeks and adequate symptom control determined by the patient. RESULTS: Sixty two patients were randomised, 29 to the oesophageal radiofrequency group and 33 to the sham group. Intention-to-treat analysis showed that 1/29 (3.4%) and 5/33 (15.1%) achieved the primary endpoint in the oesophageal radiofrequency and sham groups, respectively (NS). There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs. No pH-impedance parameter was associated with clinical response. The occurrence of adverse events was similar in both groups. CONCLUSION: This sham-controlled, randomised study did not demonstrate any efficacy of oesophageal radiofrequency for the treatment of PPI-refractory heartburn regarding symptom relief or consumption of PPIs. ClinicalTrials.gov NCT01682265.

CAD-CAP: a 25,000-image database serving the development of artificial intelligence for capsule endoscopy.

Background and study aims Capsule endoscopy (CE) is the preferred method for small bowel (SB) exploration. With a mean number of 50,000 SB frames per video, SBCE reading is time-consuming and tedious (30 to 60 minutes per video). We describe a large, multicenter database named CAD-CAP (Computer-Assisted Diagnosis for CAPsule Endoscopy, CAD-CAP). This database aims to serve the development of CAD tools for CE reading. Materials and methods Twelve French endoscopy centers were involved. All available third-generation SB-CE videos (Pillcam, Medtronic) were retrospectively selected from these centers and deidentified. Any pathological frame was extracted and included in the database. Manual segmentation of findings within these frames was performed by two pre-med students trained and supervised by an expert reader. All frames were then classified by type and clinical relevance by a panel of three expert readers. An automated extraction process was also developed to create a dataset of normal, proofread, control images from normal, complete, SB-CE videos. Results Four-thousand-one-hundred-and-seventy-four SB-CE were included. Of them, 1,480 videos (35 %) containing at least one pathological finding were selected. Findings from 5,184 frames (with their short video sequences) were extracted and delimited: 718 frames with fresh blood, 3,097 frames with vascular lesions, and 1,369 frames with inflammatory and ulcerative lesions. Twenty-thousand normal frames were extracted from 206 SB-CE normal videos. CAD-CAP has already been used for development of automated tools for angiectasia detection and also for two international challenges on medical computerized analysis.

[Successful completion of an ISO 9001 v 2015 certification process in clinical investigation research]. / Réussir une démarche de certification ISO 9001 v 2015 en investigation clinique.

Clinical investigation at the University Hospital of Nantes is carried out within the investigation department, which consists of coordination and 24 clinical research teams gathered at four different hospital sites. The Clinical Investigation Units are all equipped with a Quality Management System. This has been in place for more than 12 years and was initially created for the Clinical Investigation Units of the Clinical Investigation Centre (CIC 1413) in Nantes and then transposed in 2013, to the emerging Clinical Investigation Units. OBJECTIVE: In order to evaluate the performance of this quality approach applied to all UHC investigations, the Investigation Department is committed to obtaining an ISO 9001:2015 certification. METHODS: The quality division of the investigation department conducted the project according to a methodology, based on internal and external evaluations to determine an inventory and the retro-planning of the certification approach. RESULTS: The scope of the certification involved the investigation department of the University Hospital: 24 clinical investigation units, over 500 medical staff, 150 non-medical staff. In our certification approach, the client was the promoter of the clinical study. The process lasted 18 months and included phases of training and awareness-raising for all the staff involved. The quality management system of the investigation department has been revised and improved in accordance with current regulations. The Investigation Department obtained the ISO 9001:2015 certification for all clinical investigations at the Nantes University Hospital in June 2017 without any non-compliance. CONCLUSION: Our work shows that the investigation department has successfully adapted the ISO 9001:2015 standard to institutional clinical research. The certification for specific activities in clinical investigation is the guarantee of an optimized and relevant organization for the safety of volunteers, participating in clinical research as well as the scientific quality of the research and contributes to the satisfaction of sponsors.

Large oesophageal varice screening by a sequential algorithm using a cirrhosis blood test and optionally capsule endoscopy.

BACKGROUND & AIMS: Large oesophageal varice (LEV) screening is recommended in cirrhosis. We performed a prospective study to improve non-invasive LEV screening. DESIGN: 287 patients with cirrhosis had upper gastrointestinal endoscopy (LEV reference), oesophageal capsule endoscopy (ECE), liver elastography and blood marker analyses. CirrhoMeter (cirrhosis blood test), the most accurate non-invasive LEV test, was segmented for cirrhosis (reference comparator) or LEV. VariScreen, a sequential and partially minimally invasive diagnostic algorithm, was developed by multivariate analysis. It uses CirrhoMeter first, then ECE if CirrhoMeter cannot rule LEV out or in, and finally endoscopy if CirrhoMeter+ECE combination remains uninformative. RESULTS: Diagnostic effectiveness rates for LEV were: cirrhosis-segmented CirrhoMeter: 14.6%, LEV-segmented CirrhoMeter: 34.6%, ECE: 60.6% and VariScreen: 66.4% (P ≤ .001 for overall or pair comparison). The respective missed LEV rates were: 2.8%, 5.6%, 8.3% and 5.6% (P = .789). Spared endoscopy rates were, respectively: 15.6%, 36.0%, 70.6% and 69%, (P < .001 for overall or paired comparison except ECE vs VariScreen: P = .743). VariScreen spared 38% of ECE and reduced missed LEV by 87% compared to classical ECE performed in all patients. Excepting cirrhosis-segmented CirrhoMeter, these spared endoscopy rates were significantly higher than that of the Baveno VI recommendation (using platelets and Fibroscan): 18.4% (P < .001). Ascites and Child-Pugh class independently predicted endoscopy sparing by VariScreen: from 86.0% in compensated Child Pugh class A to 24.1% in Child-Pugh class C with ascites. CONCLUSION: VariScreen algorithm significantly reduced the missed LEV rate with ECE by 87%, ECE use by 38% and endoscopy requirement by 69%, and even 86% in compensated cirrhosis.

Metabolic and hepatic effects of bloodletting in dysmetabolic iron overload syndrome: A randomized controlled study in 274 patients.

Dysmetabolic iron overload syndrome (DIOS) is a common cause of hyperferritinemia, accounting for a mild increase of iron stores in insulin-resistant subjects. Iron removal could improve insulin sensitivity. We performed a prospective, randomized, controlled trial (NCT01015525) in nondiabetic DIOS patients with hepatic iron >50 µmol/g at magnetic resonance imaging to compare the metabolic and hepatic outcomes of 1-year maintenance of serum ferritin levels <50 µg/L by bloodletting associated with lifestyle and diet advice (LFDA) to those of LFDA only. Patients were randomly assigned (1:1) with stratification by center (n = 8) and hyperglycemia (>5.6 mmol/L). Sample size was calculated to provide 90% power and a difference in fasting glycemia of 0.25 mmol/L. Analysis was done in an intention-to-treat population. In 2010-2014, 146 patients were randomly assigned to receive venesections with LFDA and 128 to LFDA only. At the end of the study, comparison of iron-depleted patients and controls showed ferritin levels 71 ± 48 µg/L after removal of 4.9 ± 1.6 L of blood versus 733 ± 277 µg/L (P < 0.0001), glycemia 5.44 ± 0.7 versus 5.49 ± 0.7 mmol/L (P = 0.57), body weight +0.5 ± 4.3% versus -0.6 ± 3.3% (P = 0.03), homeostasis model of assessment of insulin resistance 3.39 versus 2.40 (P = 0.002), alanine aminotransaminase 33 ± 22 versus 37 ± 21 IU/L (P = 0.10), aspartate aminotransaminase 27 ± 13 versus 27 ± 10 IU/L (P = 0.81), gamma-glutamyl transferase 54 ± 138 versus 49 ± 35 IU/L (P = 0.72), Fatty Liver Index 58.9 ± 24.6 versus 61.2 ± 22.9 (P = 0.37), and Fibrosis-4 score 1.5 ± 0.6 versus 1.30 ± 0.6 (P = 0.51). Fatigue occurred in 25.3% of venesected patients versus 2.3% of controls (P < 0.0001). In the subgroup of patients who lost weight, glycemia, homeostasis model of assessment of insulin resistance, serum ferritin, lipid profile, and liver function tests improved irrespective of bloodletting. CONCLUSION: In DIOS patients, iron depletion by bloodletting does not improve metabolic and hepatic features, is associated with weight gain, and is not as well tolerated as expected; sustained modification of diet and lifestyle habits remains the first therapeutic intervention in DIOS. (Hepatology 2017;65:465-474).

Joint Model of Iron and Hepcidin During the Menstrual Cycle in Healthy Women.

Hepcidin regulates serum iron levels, and its dosage is used in differential diagnostic of iron-related pathologies. We used the data collected in the HEPMEN (named after HEPcidin during MENses) study to investigate the joint dynamics of serum hepcidin and iron during the menstrual cycle in healthy women. Ninety menstruating women were recruited after a screening visit. Six fasting blood samples for determination of iron-status variables were taken in the morning throughout the cycle, starting on the second day of the period. Non-linear mixed effect models were used to describe the evolution of iron and hepcidin. Demographic and medical covariates were tested for their effect on model parameters. Parameter estimation was performed using the SAEM algorithm implemented in the Monolix software. A general pattern was observed for both hepcidin and iron, consisting of an initial decrease during menstruation, followed by a rebound and stabilising during the second half of the cycle. We developed a joint model including a menstruation-induced decrease of both molecules at the beginning of the menses and a rebound effect after menses. Iron stimulated the release of hepcidin. Several covariates, including contraception, amount of blood loss and ferritin, were found to influence the parameters. The joint model of iron and hepcidin was able to describe the fluctuations induced by blood loss from menstruation in healthy non-menopausal women and the subsequent regulation. The HEPMEN study showed fluctuations of iron-status variables during the menstrual cycle, which should be considered when using hepcidin measurements for diagnostic purposes in women of child-bearing potential.

Screening of esophageal varices by esophageal capsule endoscopy: results of a French multicenter prospective study.

BACKGROUND AND STUDY AIM: Esophageal video capsule endoscopy (ECE) is a new technique that allows examination of the esophagus using a noninvasive approach. The aim of this study was to compare ECE with esophagogastroduodenoscopy (EGD) for the diagnosis of esophageal varices in patients with cirrhosis. PATIENTS AND METHODS: A total of 330 patients with cirrhosis and with no known esophageal varices were prospectively enrolled. Patients underwent ECE first, followed by EGD (gold standard). The endoscopists who performed EGD were blind to the ECE result. Patient satisfaction was assessed using a visual analog scale (maximum score 100). RESULTS: A total of 30 patients were excluded from the analysis because they did not undergo any endoscopic examinations. Patients (mean age 56 years; 216 male) had mainly alcoholic (45 %) or viral (27 %) cirrhosis. The diagnostic indices of ECE to diagnose and correctly stage esophageal varices were: sensitivity 76 % and 64 %, specificity 91 % and 93 %, positive predictive value 88 % and 88 %, and negative predictive value 81 % and 78 %, respectively. ECE patient satisfaction scored significantly higher than EGD (87 ±â€Š22 vs. 58 ±â€Š35; P < 0.0001). CONCLUSIONS: ECE was well tolerated and safe in patients with liver cirrhosis and suspicion of portal hypertension. The sensitivity of ECE is not currently sufficient to replace EGD as a first exploration in these patients. However, due to its excellent specificity and positive predictive value, ECE may have a role in cases of refusal or contraindication to EGD. ECE might also improve compliance to endoscopic follow-up and aid important therapeutic decision making in the prophylaxis of bleeding. TRIAL REGISTRATION: EudraCT (ID RCB 2009-A00532-55) and ClinicalTrials.gov (NCT00941421).

The prevalence and outcome of jejunal lesions visualized by small bowel capsule endoscopy in Crohn's disease.

BACKGROUND: Small bowel capsule endoscopy is the most sensitive technique for the detection of lesions in the small intestine. The aims of the study were to assess the prevalence and clinical significance of jejunal lesions detected by small bowel capsule endoscopy in patients with an established Crohn's disease. RESULTS: One hundred and eight patients, including 32 patients with ileal disease, 25 patients with colonic disease, and 51 patients with ileocolonic disease, underwent small bowel capsule endoscopy, and findings were analyzed retrospectively. Jejunal lesions were detected in 56% of these patients, of whom 18 (17%) had lesions only in the jejunum. Jejunal lesions were less frequently detected (12% versus 38%, P = 0.001) when location of the disease was limited to the colon at ileocolonoscopy. Conversely, when Crohn's disease affected the ileum, jejunal lesions were more frequently detected (40% versus 17%, P = 0.007). During a median follow-up time of 24.0 months (interquartile, 8.0-46.2), 50 clinical relapses occurred. The presence of jejunal lesions was the only independent factor associated with an increased risk of relapse (P = 0.02). In nonsmokers and in patients treated by immunosuppressors, the presence of jejunal lesions tended to increase the risk of relapse (P = 0.06 and 0.05, respectively). CONCLUSIONS: Jejunal lesions are detected in more than half of the patients with Crohn's disease. The prevalence of jejunal lesions is higher when the terminal ileum is involved and associated with an increased risk of further clinical relapse. It may be regarded as a factor of severity.

Can we shorten the small-bowel capsule reading time with the "Quick-view" image detection system?

BACKGROUND: The mean small-bowel capsule reading time is about 60 min, and shortening this reading time is a major aim. AIM: To evaluate the efficiency of the "Quick-view" detection algorithm. METHODS: Multicentre prospective comparative study. One hundred and six small bowel capsule films from 12 centres reviewed in Quick-view mode by 12 experienced readers. Reading time, image relevance, and comparison of Quick-view reading results to results of initial reading. Review of discordant result by 3 experts. RESULTS: The mean reading time in Quick-view mode was of 11.6 min (2-27). Concordant negative results were obtained in 41 cases (38.6%) and concordant positive results in 35 cases (33.0%). A discordant result was obtained in 30 (28.3%) cases: 21 false positive cases (initial reading 12 cases, Quick-view reading 9 cases), 14 false negative cases (initial reading 7, Quick-view 7). Four out of 7 lesions missed at Quick-view reading were not present on the Quick-view film (theoretical sensitivity 93.5%). CONCLUSION: The Quick-view informatic algorithm detected nearly 94% of significant lesions, and Quick-view reading was as efficient as the initial reading and much shorter. These results are to be confirmed by further studies, but suggest an excellent sensitivity for the Quick-view algorithm.

Second-generation colon capsule endoscopy compared with colonoscopy.

BACKGROUND: Colon capsule endoscopy (CCE) represents a noninvasive technology that allows visualization of the colon without requiring sedation and air insufflation. A second-generation colon capsule endoscopy system (PillCam Colon 2) (CCE-2) was developed to increase sensitivity for colorectal polyp detection compared with the first-generation system. OBJECTIVE: To assess the feasibility, accuracy, and safety of CCE-2 in a head-to-head comparison with colonoscopy. DESIGN AND SETTING: Prospective, multicenter trial including 8 European sites. PATIENTS: This study involved 117 patients (mean age 60 years). Data from 109 patients were analyzed. INTERVENTION: CCE-2 was prospectively compared with conventional colonoscopy as the criterion standard for the detection of colorectal polyps that are ≥6 mm or masses in a cohort of patients at average or increased risk of colorectal neoplasia. Colonoscopy was independently performed within 10 hours after capsule ingestion or on the next day. MAIN OUTCOME MEASUREMENTS: CCE-2 sensitivity and specificity for detecting patients with polyps ≥6 mm and ≥10 mm were assessed. Capsule-positive but colonoscopy-negative cases were counted as false positive. Capsule excretion rate, level of bowel preparation, and rate of adverse events also were assessed. RESULTS: Per-patient CCE-2 sensitivity for polyps ≥6 mm and ≥10 mm was 84% and 88%, with specificities of 64% and 95%, respectively. All 3 invasive carcinomas were detected by CCE-2. The capsule excretion rate was 88% within 10 hours. Overall colon cleanliness for CCE-2 was adequate in 81% of patients. LIMITATIONS: Not unblinding the CCE-2 results at colonoscopy; heterogenous patient population; nonconsecutive patients. CONCLUSION: In this European, multicenter study, CCE-2 appeared to have a high sensitivity for the detection of clinically relevant polypoid lesions, and it might be considered an adequate tool for colorectal imaging.

Screening for esophagitis and Barrett's esophagus with wireless esophageal capsule endoscopy: a multicenter prospective trial in patients with reflux symptoms.

BACKGROUND AND AIM: Esophageal capsule endoscopy (ECE) is a new technology that allows noninvasive investigation of the esophagus. Our aim was to evaluate prospectively the diagnostic yield of ECE in patients with chronic reflux symptoms. PATIENTS AND METHODS: Eighty-nine patients (40 men, mean age 54 yr) referred to five endoscopic centers for esophagogastroduodenoscopy (EGD) were enrolled. Patients first underwent ECE, then EGD; endoscopists who performed the EGD were blind to the ECE data that were interpreted separately by two independent readers. The Los Angeles, Prague, and Montreal classification systems were used to describe endoscopic findings. RESULTS: Seventy-seven patients completed the study. Esophagitis and endoscopically suspected esophageal metaplasia (ESEM) were present in 24 and 10 patients, respectively. Columnar lining was histologically confirmed in seven patients (3 with specialized intestinal metaplasia and 4 with gastric metaplasia). The kappa values for interobserver agreement regarding the diagnosis of esophagitis and ESEM were 0.67 (0.49-0.85) and 0.49 (0.17-0.81), respectively. The diagnostic yields of ECE to detect esophagitis and ESEM were as follows: sensitivity 79% and 60%, specificity 94% and 100%, positive predictive value (PPV) 83% and 100%, negative predictive value (NPV) 92% and 95%, respectively. CONCLUSION: As a screening tool in patients with reflux symptoms, ECE has an excellent specificity and NPV for the diagnosis of esophagitis and ESEM. However, its sensitivity for the diagnosis of ESEM is not optimal. Further studies are necessary to improve the procedure, and to compare the cost-effectiveness of strategies using ECE or EGD.

The effects of regular consumption of short-chain fructo-oligosaccharides on digestive comfort of subjects with minor functional bowel disorders.

A comparative, randomised, double-blind trial was performed in the medical departments of five hospitals to study the effects of regular consumption of short-chain fructo-oligosaccharides (sc-FOS) on the digestive comfort of subjects with minor functional bowel disorders (FBD). In step 1, 2235 subjects were questioned to assess the incidence and intensity of digestive disorders. In step 2, 105 of these patients diagnosed with minor FBD were randomised into two groups to receive either 5 g sc-FOS or 5 g placebo (sucrose and maltodextrins) per d over a 6-week period. The incidence and intensity of digestive disorders were assessed at the end of the treatment period (day 43) using the step 1 questionnaires. A quality-of-life questionnaire was also completed at the start and end of the treatment period to assess potential effects on well-being and social performance. In step 1, 44 % of the subjects questioned presented FBD, of whom 57.1 % suffered from minor FBD. In step 2, on day 43, the intensity of digestive disorders decreased by 43.6 % in the sc-FOS group v. a 13.8 % increase in the placebo group (P = 0.026). Symptoms were experienced less frequently by 75.0 % of subjects in the sc-FOS group, while 53.8 % of controls experienced no change (P = 0.064). Using the functional digestive disorders quality of life questionnaire, the discomfort item scores increased in the sc-FOS group (P = 0.031). However, expressed as change in quality of life (improvement, worsening or unchanged), daily activities were significantly improved in the sc-FOS group (P = 0.022). Regular consumption of sc-FOS may improve digestive comfort in a working population not undergoing medical treatment.

Value of wireless capsule endoscopy in patients with indeterminate colitis (inflammatory bowel disease type unclassified).

BACKGROUND: Wireless capsule endoscopy (WCE) can identify small bowel mucosal lesions not seen with other imaging modalities. This technique can therefore play an important diagnostic role in the evaluation of patients with inflammatory bowel disease type unclassified (IBDU). We report on a multicentric study whose objective was to evaluate the value of WCE to increase diagnostic accuracy in categorizing IBDU. METHODS: Thirty patients with IBDU and negative serology were included. WCE was performed with a standard Pillcam capsule. Outcome measures were classified as suggestive of Crohn's disease (CD) when -3 ulcerations were present. RESULTS: WCE displayed endoscopic features suggestive for CD in 5 patients. In 6 other patients, WCE was negative, but repeated ileocolonoscopy with biopsies performed during follow-up evaluation revealed CD in 5 and ulcerative colitis (UC) in 1 patient. UC was found in a seventh case at colectomy performed just after WCE. Eighteen patients remained with a diagnosis of IBDU 16 months on average after WCE. CONCLUSIONS: WCE is a potentially clinically useful technique for categorizing a subgroup of patients with IBDU, although negative WCE does not exclude further diagnosis of CD. Patients with negative WCE who remain IBDU at follow-up evaluation may belong to an original subgroup of IBD.

Rabeprazole test for the diagnosis of gastro-oesophageal reflux disease: results of a study in a primary care setting.

AIM: To determine the diagnostic value of the rabeprazole test in patients seen by general practitioners. METHODS: Eighty-three patients with symptoms suggestive of GERD were enrolled by general practitioners in this multi-centre, randomized and double-blind study. All patients received either rabeprazole (20 mg bid) or a placebo for one week. The diagnosis of GERD was established on the presence of mucosal breaks at endoscopy and/or an abnormal esophageal 24-h pH test. The test was considered to be positive if patients reported at least a "clear improvement" of symptoms on a 7-point Likert scale. RESULTS: The sensitivities of the test for rabeprazole and the placebo were 83% and 40%, respectively. The corresponding specificity, positive and negative predictive values were 45% and 67%, 71% and 71%, and 62% and 35%, respectively. A receiver operating characteristics (ROC) analysis confirmed that the best discriminatory cut-off corresponded to description of "clear improvement". CONCLUSION: The poor specificity of the proton-pump inhibitor (PPI) test does not support such an approach to establish a diagnosis of GERD in a primary care setting.

Does the "Suspected Blood Indicator" improve the detection of bleeding lesions by capsule endoscopy?

BACKGROUND: The "Suspected Blood Indicator" (SBI), a feature included in the software for interpretation of capsule endoscopy (CE), is designed to facilitate detection of bleeding lesions in the small bowel. This study evaluated the sensitivity and the specificity of the SBI in patients who underwent CE for obscure GI bleeding (OGIB). METHODS: CE recordings from patients with OGIB recruited in 7 centers were read by experts blinded to the red SBI tags. They classified lesions of interest as bleeding or as having a potential for bleeding that was high (P2), low (P1), or absent (P0). The SBI tags then were marked by a another investigator. Concordance was acknowledged when frames selected by the expert reader, and those tagged by the SBI had the same time code. RESULTS: A total of 156 recordings were evaluated. In 83, there was either no lesion (n = 71) or a P0 lesion (n = 12); these CE recordings were regarded as normal. Among the 73 abnormal recordings, 114 P2 and 92 P1 lesions were identified. A total of 154 red tags were analyzed. Sensitivity, specificity, and positive and negative predictive values of SBI were 37%, 59%, 50%, and 46%, respectively, for detection of the presence of a P2 or P1 lesion in front of a red tag. CONCLUSIONS: SBI-based detection of intestinal lesions with the potential for bleeding is of limited clinical value in practice and does not reduce the time required for interpretation of CE.

Colonic fermentation influences lower esophageal sphincter function in gastroesophageal reflux disease.

BACKGROUND & AIMS: Colonic fermentation of carbohydrates is known to influence gastric and esophageal motility in healthy subjects. This study investigated the effects of colonic fermentation induced by oral administration of fructooligosaccharides (FOS) in patients with gastroesophageal reflux disease (GERD). METHODS: In the cross-over design used in the study, 9 patients with symptomatic GERD were administered a low-residue diet (i.e., 10 g fiber/day) during 2, 7-day periods, receiving either 6.6 g of FOS or placebo 3 times daily after meals. Each period was separated by a wash out of at least 3 weeks. On day 7, esophageal motility and pH were recorded in fasting conditions and after a test meal containing 6.6 g of FOS or placebo. Breath hydrogen concentrations (reflecting colonic fermentation) and plasma concentrations of glucagon-like peptide 1 (GLP-1), peptide YY, and cholecystokinin were monitored. RESULTS: Compared with placebo, FOS led to a significant increase in the number of transient lower esophageal sphincter relaxations (TLESRs) and reflux episodes, esophageal acid exposure, and the symptom score for GERD. The integrated plasma response of GLP-1 was significantly higher after FOS than placebo. CONCLUSIONS: Colonic fermentation of indigestible carbohydrates increases the rate of TLESRs, the number of acid reflux episodes, and the symptoms of GERD. Although different mechanisms are likely to be involved, excess release of GLP-1 may account, at least in part, for these effects.