Anne Foley

A multicenter randomized comparison of the Endocapsule and the Pillcam SB

BACKGROUND Video capsule endoscopy has been shown to be the single most effective endoscopic procedure for identifying the source of obscure GI bleeding (OGIB). OBJECTIVE Our purpose was to report on the Food and Drug Administration pivotal trial in which the Endocapsule (EC) (Olympus America, Allentown, Pa) was compared with the Pillcam SB (PSB) (Given Imaging, Yoqneam, Israel) in patients with OGIB. DESIGN A novel trial design was used in which the EC and the PSB were swallowed by the same patient 40 minutes apart, in randomized order. SETTING Four academic medical centers. PATIENTS Patients with OGIB aged 18 to 85 years who had either been transfused or who had a hematocrit of <31% in males or <28% in females. INTERVENTIONS Both video capsules were swallowed in random order. Videos from the PSB were read locally for patient management. All videos were then read by at least 2 independent readers for normal versus abnormal categorization, a diagnosis, capsule transit time, reading time, and a subjective assessment of image quality. MAIN OUTCOME MEASUREMENT Categorization of videos as either normal or abnormal. RESULTS Data from 51 of 63 enrolled patients were analyzed. Nine patients were excluded for technical reasons and 3 for protocol violations. Twenty-four videos were read as normal and 14 as abnormal from both capsules. Disagreement occurred in 13. No adverse events were reported for either capsule. Overall agreement was 38 of 51 (74.5%) with a kappa of 0.48, P = .008. LIMITATIONS Although ingestion order was randomized, the videos could not be read blind owing to a different shape of the image margin. CONCLUSIONS (1) Both devices were safe and had a comparable diagnostic yield within the range previously reported. (2) There was a subjective difference in image quality favoring the EC. (3) This study design provided unique information about capsule movement in the small intestine and the lack of electromechanical interference between 2 different capsules.

Timing of video capsule endoscopy relative to overt obscure GI bleeding: implications from a retrospective study

BACKGROUND Diagnostic yield of video capsule endoscopy (VCE) may be higher if it is performed closer to the time of overt obscure GI bleeding (OOGIB). OBJECTIVE To evaluate the diagnostic yield of VCE and rate of therapeutic intervention for OOGIB for inpatients and outpatients with respect to timing of the intervention. DESIGN Retrospective cohort study. SETTING Tertiary academic center. PATIENTS Patients who had VCE for OOGIB between August 2008 and August 2010. INTERVENTIONS VCE for inpatients versus outpatients. MAIN OUTCOME MEASURES Diagnostic yield and rate of therapeutic intervention for inpatients versus outpatients. RESULTS One hundred forty-four inpatients (65 women) and 116 outpatients (49 women) were included. Diagnostic yield was 65.9% for inpatients versus 53.4% for outpatients (P = .054). Inpatients were divided into those who had VCE within 3 days (<3 days; n = 90) of admission versus after 3 days (>3 days; n = 54). Active bleeding and/or an angioectasia was found in 44.4% of the <3-day group compared with 27.8% of the >3-day group (P = .046) versus 25.8% of the outpatients. Therapeutic intervention was performed in 18.9% of the <3-day group versus 7.4% of the >3-day group (P = .046) versus 10.3% of outpatients. Diagnostic yield and therapeutic intervention rate between the >3-day group and outpatients were not significantly different. Length of stay (days) was less in the <3-day cohort, at 6.1 versus 10.3 in the >3-day cohort (P < .0001). LIMITATIONS Long-term outcomes were not studied. This was a retrospective study. CONCLUSIONS Early deployment of VCE within 3 days of admission results in a higher diagnostic yield and therapeutic intervention rate and an associated reduction of length of stay.

Computerized 3-dimensional localization of a video capsule in the abdominal cavity: validation by digital radiography

BACKGROUND Wireless video capsule endoscopy allows the noninvasive visualization of the small intestine. Currently, capsules do not provide localization information while traversing the GI tract. OBJECTIVE To report on the radiological validation of 3-dimensional localization software incorporated in a newly developed capsule. By using radiofrequency transmission, the software measures the strength of the capsules signal to locate the position of the capsule. SETTING This study was performed at the University of Massachusetts Medical Center, Worcester, Mass. PATIENTS Thirty healthy volunteers consented to the experimental procedure. DESIGN After ingestion of the capsule, subjects had 5 sets of anteroposterior and lateral radiographs taken every 30 minutes while the software calculated the position of the capsule. By using the radiographs, we calculated the location of the capsule in the abdominal cavity and compared the results with those generated by the software. RESULTS Average error (and standard deviation) among the 3-dimensional coordinates was X, 2.00 cm (1.64); Y, 2.64 cm (2.39); and Z, 2.51 cm (1.83). The average total spatial error among all measurements was 13.26 cm(3) (22.72). There was a correlation between increased subject body mass index and the 3-dimensional software measurement error. LIMITATIONS This study was performed in healthy volunteers and needs further validation in patients with small intestinal disorders. CONCLUSIONS The new 3-dimensional software provides localization of the capsule consistent with radiological observations. However, further validation of the softwares clinical utility is required with a prospective clinical trial.

Multiplex detection of pancreatic cancer biomarkers using a SERS-based immunoassay

Early diagnosis of pancreatic cancer (PC) is critical to reduce the mortality rate of this disease. Current biological analysis approaches cannot robustly detect several low abundance PC biomarkers in sera, limiting the clinical application of these biomarkers. Enzyme linked immunosorbent assay and radioimmunoassay are two common platforms for detection of biomarkers; however, they suffer from some limitation. This study demonstrates a novel system for multiplex detection of pancreatic biomarkers CA19-9, MMP7 and MUC4 in sera samples with high sensitivity using surface enhanced Raman spectroscopy. Measuring the levels of these biomarkers in PC patients, pancreatitis patients, and healthy individuals reveals the unique expression pattern of these markers in PC patients, suggesting the great potential of using this approach for early diagnostics of PCs.

Sa1216 Management Differences Between Early and Late-Onset Inflammatory Bowel Disease

Background: As our population has aged more patients are being diagnosed with inflammatory bowel disease (IBD) at a later age. Despite the limited literature on the subject, clinical observation suggests that patients with late-onset IBD (LOIBD) have a different severity of disease compared to younger patients and, therefore, may have different management requirements. The primary objective of this study was to perform a retrospective analysis of the disease severity and therapy requirements of patients with a LOIBD as compared to those diagnosed at an earlier age. Methods: Patients were selected at random from a list of those billed for diagnosis codes attributed to inflammatory bowel disease. Of our initial list of 350 patients, we excluded 88 patients who were inappropriately coded as having IBD leaving us with a final list of 262 patients. We separated our list into three cohorts: those diagnosed with IBD before the age of 45, but who are currently younger than 45 (Group 1); those diagnosed with IBD before the age of 45, but who are currently older than 45