Diagnostic accuracy and interobserver agreement of digital single-operator cholangioscopy for indeterminate biliary strictures.

BACKGROUND AND AIMS: Digital single-operator cholangioscopy (d-SOC) with cholangioscopic biopsy sampling has shown promise in the evaluation of indeterminate biliary strictures. Some studies have suggested higher sensitivity for visual impression compared with biopsy sampling, although assessors were not blinded to previous investigations. We aimed to investigate the diagnostic accuracy and interobserver agreement (IOA) of d-SOC in the visual appraisal of biliary strictures when blinded to additional information. METHODS: A multicenter, international cohort study was performed. Cholangioscopic videos in patients with a known final diagnosis were systematically scored. Pseudonymized videos were reviewed by 19 experts in 2 steps: blinded for patient history and investigations and unblinded. RESULTS: Forty-four high-quality videos were reviewed of 19 benign and 25 malignant strictures. The sensitivity and specificity for the diagnosis of malignancy was 74.2% and 46.9% (blinded) and 72.7% and 62.5% (unblinded). Cholangioscopic certainty of a malignant diagnosis led to overdiagnosis (sensitivity, 90.6%; specificity, 33%), especially if no additional information was provided. The IOA for the presence of malignancy was fair for both assessments (Fleiss' κ = .245 [blinded] and κ = .321 [unblended]). For individual visual features, the IOA ranged from slight to moderate for both assessments (κ = .059-.400 vs κ = .031-.452). CONCLUSIONS: This study showed low sensitivity and specificity for blinded and unblinded d-SOC video appraisal of indeterminate biliary strictures, with considerable interobserver variation. Although reaching a consensus on the optical features of biliary strictures remains important, optimizing visually directed biopsy sampling may be the most important role of cholangioscopy in biliary stricture assessment.

Use of capsule endoscopy in inflammatory bowel disease in clinical practice in Spain. Results from a national survey. / Uso de la cápsula endoscópica en enfermedad inflamatoria intestinal en práctica clínica en España. Resultados de una encuesta nacional.

INTRODUCTION: Small bowel capsule endoscopy (SBCE) is a non-invasive diagnostic technique whose use in inflammatory bowel disease (IBD) has spread. A panenteric capsule, PillCam Crohn's (PCC), has recently been developed. We lack information on the availability and use of the CEID and PCC in our environment. METHODS: We conducted an electronic and anonymous survey among the members of the Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) [Spanish Working Group on Crohn's Disease and Ulcerative Colitis] and the Asociación Española de Gastroenterología (AEG) [Spanish Association of Gastroenterology], consisting of 37 multiple-choice questions. RESULTS: One hundred and fifty members participated, the majority dedicated to IBD (69.3%). 72.8% worked at centres with an IBD unit. 79% had SBCE available at their hospital, 14% referred patients to another centre; 22% had a PCC available, 9% referred patients to another centre. 79.3% of respondents with available SBCE used it in a small percentage of patients with IBD and 15.6% in the majority. The most frequent scenarios were suspicion of Crohn's disease (76.3%), assessment of inflammatory activity (54.7%) and assessment of the extent of the disease (54.7%). More than half (59.7%) preferentially used the Patency capsule to assess intestinal patency. Almost all respondents (99.3%) considered that training resources should be implemented in this technique. CONCLUSIONS: SBCE is widely available in Spanish hospitals for the management of IBD, although its use is still limited. There is an opportunity to increase training in this technique, and consequently its use.

Nomenclature and semantic descriptions of ulcerative and inflammatory lesions seen in Crohn's disease in small bowel capsule endoscopy: An international Delphi consensus statement.

BACKGROUND: In the medical literature, the nomenclature and descriptions (ND) of small bowel (SB) ulcerative and inflammatory (U-I) lesions in capsule endoscopy (CE) are scarce and inconsistent. Inter-observer variability in interpreting these findings remains a major limitation in the assessment of the severity of mucosal lesions, which can impact negatively on clinical care, training and research on SB-CE. OBJECTIVE: Focusing on SB-CE in Crohn's disease (CD), our aim is to establish a consensus on the ND of U-I lesions. METHODS: An international panel of experienced SB-CE readers was formed during the 2016 United European Gastroenterology Week meeting. A core group of five CE and inflammatory bowel disease (IBD) experts established an Internet-based, three-round Delphi consensus but did not participate in the voting process. The core group built illustrated questionnaires, including SB-CE still frames of U-I lesions from patients with documented CD. Twenty-seven other experts were asked to rate and comment on the different proposals for the ND of the most frequent SB U-I lesions. For each round, we used a 6-point rating scale (varying from 'strongly disagree' to 'strongly agree'). The consensus was reached when at least 80 % of the voting members scored the statement within the 'agree' or 'strongly agree' categories. RESULTS: A 100% participation rate was obtained for all the rounds. Consensual ND were reached for the following seven U-I lesions: aphthoid erosion, deep ulceration, superficial ulceration, stenosis, edema, hyperemia and denudation. CONCLUSION: Considering the most frequent SB U-I lesions seen in CE in CD, a consensual ND was reached by the international group of experts. These descriptions and names are useful not only for daily practice and medical education, but also for medical research.

Capsule endoscopy, a useful tool for the diagnosis of a tapeworm infection.

The incidence of parasitic infections is rising in developed countries and its diagnosis might be challenging. We present the case of a woman diagnosed with a tapeworm infection by capsule endsocopy. Capsule endoscopy may have a role when the microscopic stool examination is negative in patients with non-specific symptoms.

Use of patency capsule in daily practice.

We read with great interest the paper by Albuquerque et al. entitled "Predictive factors of small bowel patency in Crohn's disease patients". Despite being a safe procedure, capsule endoscopy (CE) retention is a complication that should be kept in mind, especially in Crohn's disease (CD) patients. However, the risk of CE retention can be minimized using the patency capsule (PC). Although some clinical trials confirm its effectiveness, its use in daily practice has been poorly investigated. Albuquerque et al. report a PC negative predictive value (NPV) of 100% in this setting.

Development and validation of a scoring index to predict the presence of lesions in capsule endoscopy in patients with suspected Crohn's disease of the small bowel: a Spanish multicenter study.

BACKGROUND: Capsule endoscopy (CE) is the first-line investigation in cases of suspected Crohn's disease (CD) of the small bowel, but the factors associated with a higher diagnostic yield remain unclear. OBJECTIVE: Our aim is to develop and validate a scoring index to assess the risk of the patients in this setting on the basis of biomarkers. PATIENTS AND METHODS: Data on fecal calprotectin, C-reactive protein, and other biomarkers from a population of 124 patients with suspected CD of the small bowel studied by CE and included in a PhD study were used to build a scoring index. This was first used on this population (internal validation process) and after that on a different set of patients from a multicenter study (external validation process). RESULTS: An index was designed in which every biomarker is assigned a score. Three risk groups have been established (low, intermediate, and high). In the internal validation analysis (124 individuals), patients had a 10, 46.5, and 81% probability of showing inflammatory lesions in CE in the low-risk, intermediate-risk, and high-risk groups, respectively. In the external validation analysis, including 410 patients from 12 Spanish hospitals, this probability was 15.8, 49.7, and 80.6% for the low-risk, intermediate-risk, and high-risk groups, respectively. CONCLUSION: Results from the internal validation process show that the scoring index is coherent, and results from the external validation process confirm its reliability. This index can be a useful tool for selecting patients before CE studies in cases of suspected CD of the small bowel.

Role of capsule endoscopy in alarm features and non-responsive celiac disease: A European multicenter study.

BACKGROUND AND AIM: The role of capsule endoscopy (CE) in established celiac disease (CD) remains unclear. Our objective was to analyze the usefulness of CE in the suspicion of complicated CD. METHODS: This was a retrospective multicenter study. One hundred and eighty-nine celiac patients (mean age: 46.6 ± 16.6, 30.2% males) who underwent CE for alarm symptoms (n = 86, 45.5%) or non-responsive CD (n = 103, 54.5%) were included. Diagnostic yield (DY), therapeutic impact and safety were analyzed. RESULTS: Capsule endoscopy was completed in 95.2% of patients (small bowel transit time: 270.5 ± 100.2 min). Global DY was 67.2%, detecting atrophic mucosa (n = 92, 48.7%), ulcerative jejunoileitis (n = 21, 11.1%), intestinal lymphoma (n = 7, 3.7%) and other enteropathies (n = 7, 3.7%, six Crohn's disease cases and one neuroendocrine tumor). The DY of CE was significantly higher in patients presenting with non-responsive disease compared to patients with alarm symptoms (73.8% vs 59.3%, P = 0.035). The new findings of the CE modified management in 59.3% of the cases. There were no major complications. CONCLUSION: Capsule endoscopy may be a moderately helpful and safe diagnostic tool in the suspicion of complicated CD, modifying the clinical course of these patients.

Gastroduodenal lesions detected during small bowel capsule endoscopy: incidence, diagnostic and therapeutic impact.

BACKGROUND: Capsule endoscopy was primarily designed for the investigation of the small bowel. However, it may also identify lesions in other segments of the gastrointestinal tract. The aim of the current study was to evaluate the incidence of gastroduodenal abnormalities during small bowel capsule endoscopy and its impact on patient diagnosis and management. PATIENTS AND METHODS: This study is a retrospective analysis of data from 2,217 consecutive capsule endoscopy procedures performed at a single tertiary-care center between January 2008 and February 2016. Patient baseline characteristics, gastroduodenal lesions, diagnosis and management before and after capsule endoscopy were recorded and a descriptive analysis was performed. RESULTS: Two thousands and two hundred seventeen patients were finally included in the analysis. One thousand and seventy patients were male (48.2%) and the mean age was 56.1 ± 19.5 years (range: 12-93). Obscure gastrointestinal bleeding (52.3%) and inflammatory bowel disease (18.3%) were the main procedure indications. Gastroduodenal abnormalities were detected by capsule endoscopy in 696 (31.4%) of 2,217 patients. The most common types of missed gastric and duodenal lesions found were gastric erosions (35.4%), findings suggestive of chronic gastritis (22.9%), duodenal erosions (28.1%) and duodenal erythema (23.5%). This information had a clinical or diagnostic impact of 26.2% and a therapeutic impact of 15.5%. CONCLUSION: Capsule endoscopy detects not only small bowel lesions but also some gastroduodenal lesions that may be overlooked during an initial gastroscopy. Therefore, all gastroduodenal images should be read during small bowel capsule endoscopy as it may provide relevant information that result in changes in patient management.

Role of capsule endoscopy in suspected celiac disease: A European multi-centre study.

AIM: To analyze the diagnostic yield (DY), therapeutic impact (TI) and safety of capsule endoscopy (CE). METHODS: This is a multi-centre, observational, analytical, retrospective study. A total of 163 patients with suspicion of celiac disease (CD) (mean age = 46.4 ± 17.3 years, 68.1% women) who underwent CE from 2003 to 2015 were included. Patients were divided into four groups: seronegative CD with atrophy (Group-I, n = 19), seropositive CD without atrophy (Group-II, n = 39), contraindication to gastroscopy (Group-III, n = 6), seronegative CD without atrophy, but with a compatible context (Group-IV, n = 99). DY, TI and the safety of CE were analysed. RESULTS: The overall DY was 54% and the final diagnosis was villous atrophy (n = 65, 39.9%), complicated CD (n = 12, 7.4%) and other enteropathies (n = 11, 6.8%; 8 Crohn's). DY for groups I to IV was 73.7%, 69.2%, 50% and 44.4%, respectively. Atrophy was located in duodenum in 24 cases (36.9%), diffuse in 19 (29.2%), jejunal in 11 (16.9%), and patchy in 10 cases (15.4%). Factors associated with a greater DY were positive serology (68.3% vs 49.2%, P = 0.034) and older age (P = 0.008). On the other hand, neither sex nor clinical presentation, family background, positive histology or HLA status were associated with DY. CE results changed the therapeutic approach in 71.8% of the cases. Atrophy was associated with a greater TI (92.3% vs 45.3%, P < 0.001) and 81.9% of the patients responded to diet. There was one case of capsule retention (0.6%). Agreement between CE findings and subsequent histology was 100% for diagnosing normal/other conditions, 70% for suspected CD and 50% for complicated CD. CONCLUSION: CE has a high DY in cases of suspicion of CD and it leads to changes in the clinical course of the disease. CE is safe procedure with a high degree of concordance with histology and it helps in the differential diagnosis of CD.

Symptomatic retention of the patency capsule: a multicenter real life case series.

BACKGROUND AND AIMS: The patency capsule is designed to evaluate the patency of the small bowel before administration of small-bowel capsule endoscopy (SBCE) in patients at high risk of retention. The utilization of a patency capsule may be associated with a risk of symptomatic retention, but very few cases have been reported to date. The aim of our study was to describe our experience with this rare complication of a patency capsule. METHODS: This was a multicenter retrospective case series. The medical records of patients who underwent a patency capsule test were scanned and all cases of symptomatic retention were collected. RESULTS: In total, 20 symptomatic cases of retention out of 1615 (1.2 %) patency capsule tests were identified; in one patient, the patency capsule was retained in the esophagus, in the rest, the capsule was detected in the small bowel resulting in abdominal pain or small-bowel obstruction. One patient (5 %) required surgery; all other patients resolved spontaneously or after corticosteroid therapy. CONCLUSIONS: Symptomatic patency capsule retention is a very rare complication with a favorable prognosis. It should be recognized but its use in patients with suspected small-bowel stenosis should not be discouraged.

Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population.

BACKGROUND & AIMS: Capsule colonoscopy is a minimally invasive imaging method. We measured the accuracy of this technology in detecting polyps 6 mm or larger in an average-risk screening population. METHODS: In a prospective study, asymptomatic subjects (n = 884) underwent capsule colonoscopy followed by conventional colonoscopy (the reference) several weeks later, with an endoscopist blinded to capsule results, at 10 centers in the United States and 6 centers in Israel from June 2011 through April 2012. An unblinded colonoscopy was performed on subjects found to have lesions 6 mm or larger by capsule but not conventional colonoscopy. RESULTS: Among the 884 subjects enrolled, 695 (79%) were included in the analysis of capsule performance for all polyps. There were 77 exclusions (9%) for inadequate cleansing and whole-colon capsule transit time fewer than 40 minutes, 45 exclusions (5%) before capsule ingestion, 15 exclusions (2%) after ingestion and before colonoscopy, and 15 exclusions (2%) for site termination. Capsule colonoscopy identified subjects with 1 or more polyps 6 mm or larger with 81% sensitivity (95% confidence interval [CI], 77%-84%) and 93% specificity (95% CI, 91%-95%), and polyps 10 mm or larger with 80% sensitivity (95% CI, 74%-86%) and 97% specificity (95% CI, 96%-98%). Capsule colonoscopy identified subjects with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity (95% CI, 82%-93) and 82% specificity (95% CI, 80%-83%), and 10 mm or larger with 92% sensitivity (95% CI, 82%-97%) and 95% specificity (95% CI, 94%-95%). Sessile serrated polyps and hyperplastic polyps accounted for 26% and 37%, respectively, of false-negative findings from capsule analyses. CONCLUSIONS: In an average-risk screening population, technically adequate capsule colonoscopy identified individuals with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity and 82% specificity. Capsule performance seems adequate for patients who cannot undergo colonoscopy or who had incomplete colonoscopies. Additional studies are needed to improve capsule detection of serrated lesions. Clinicaltrials.gov number: NCT01372878.