Small-bowel capsule endoscopy in patients with Meckel's diverticulum: clinical features, diagnostic workup, and findings. A European multicenter I-CARE study.

BACKGROUND AND AIMS: Meckel's diverticulum (MD) may remain silent or be associated with adverse events such as GI bleeding. The main aim of this study was to evaluate indicative small-bowel capsule endoscopy (SBCE) findings, and the secondary aim was to describe clinical presentation in patients with MD. METHODS: This retrospective European multicenter study included patients with MD undergoing SBCE from 2001 until July 2021. RESULTS: Sixty-nine patients with a confirmed MD were included. Median age was 32 years with a male-to-female ratio of approximately 3:1. GI bleeding or iron-deficiency anemia was present in nearly all patients. Mean hemoglobin was 7.63 ± 1.8 g/dL with a transfusion requirement of 52.2%. Typical capsule endoscopy (CE) findings were double lumen (n = 49 [71%]), visible entrance into the MD (n = 49 [71%]), mucosal webs (n = 30 [43.5%]), and bulges (n = 19 [27.5%]). Two or more of these findings were seen in 48 patients (69.6%). Ulcers were detected in 52.2% of patients (n = 36). In 63.8% of patients (n = 44), a combination of double lumen and visible entrance into the MD was evident, additionally revealing ulcers in 39.1% (n = 27). Mean percent SB (small bowel) transit time for the first indicative image of MD was 57% of the total SB transit time. CONCLUSIONS: Diagnosis of MD is rare and sometimes challenging, and a preoperative criterion standard does not exist. In SBCE, the most frequent findings were double-lumen sign and visible diverticular entrance, sometimes together with ulcers.

Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022.

MR1: ESGE recommends small-bowel capsule endoscopy as the first-line examination, before consideration of other endoscopic and radiological diagnostic tests for suspected small-bowel bleeding, given the excellent safety profile of capsule endoscopy, its patient tolerability, and its potential to visualize the entire small-bowel mucosa.Strong recommendation, moderate quality evidence. MR2: ESGE recommends small-bowel capsule endoscopy in patients with overt suspected small-bowel bleeding as soon as possible after the bleeding episode, ideally within 48 hours, to maximize the diagnostic and subsequent therapeutic yield.Strong recommendation, high quality evidence. MR3: ESGE does not recommend routine second-look endoscopy prior to small-bowel capsule endoscopy in patients with suspected small-bowel bleeding or iron-deficiency anemia.Strong recommendation, low quality evidence. MR4: ESGE recommends conservative management in those patients with suspected small-bowel bleeding and high quality negative small-bowel capsule endoscopy.Strong recommendation, moderate quality evidence. MR5: ESGE recommends device-assisted enteroscopy to confirm and possibly treat lesions identified by small-bowel capsule endoscopy.Strong recommendation, high quality evidence. MR6: ESGE recommends the performance of small-bowel capsule endoscopy as a first-line examination in patients with iron-deficiency anemia when small bowel evaluation is indicated.Strong recommendation, high quality evidence. MR7: ESGE recommends small-bowel capsule endoscopy in patients with suspected Crohn's disease and negative ileocolonoscopy findings as the initial diagnostic modality for investigating the small bowel, in the absence of obstructive symptoms or known bowel stenosis.Strong recommendation, high quality evidence. MR8: ESGE recommends, in patients with unremarkable or nondiagnostic findings from dedicated small-bowel cross-sectional imaging, small-bowel capsule endoscopy as a subsequent investigation if deemed likely to influence patient management.Strong recommendation, low quality evidence. MR9: ESGE recommends, in patients with established Crohn's disease, the use of a patency capsule before small-bowel capsule endoscopy to decrease the capsule retention rate.Strong recommendation, moderate quality evidence. MR10: ESGE recommends device-assisted enteroscopy (DAE) as an alternative to surgery for foreign bodies retained in the small bowel requiring retrieval in patients without acute intestinal obstruction.Strong recommendation, moderate quality evidence. MR11: ESGE recommends DAE-endoscopic retrograde cholangiopancreatography (DAE-ERCP) as a first-line endoscopic approach to treat pancreaticobiliary diseases in patients with surgically altered anatomy (except for Billroth II patients).Strong recommendation, moderate quality evidence.

Performance measures for colonoscopy in inflammatory bowel disease patients: European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative.

The European Society of Gastrointestinal Endoscopy (ESGE) presents a short list of performance measures for colonoscopy in inflammatory bowel disease (IBD) patients. Current performance measures for colonoscopy mainly focus on detecting (pre)malignant lesions. However, these performance measures are not relevant for all colonoscopy indications in IBD patients. Therefore, our aim was to provide endoscopy services across Europe and other interested countries with a tool for quality monitoring and improvement in IBD colonoscopy. Eight key performance measures and one minor performance measure were recommended for measurement and evaluation in daily endoscopy practice.

Performance measures for the SACRED team-centered approach to advanced gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative.

The European Society of Gastrointestinal Endoscopy and United European Gastroenterology have defined performance measures for upper and lower gastrointestinal, pancreaticobiliary, and small-bowel endoscopy. Quality indicators to guide endoscopists in the growing field of advanced endoscopy are also underway. We propose that equal attention is given to developing the entire advanced endoscopy team and not the individual endoscopist alone.We suggest that the practice of teams intending to deliver high quality advanced endoscopy is underpinned by six crucial principles concerning: selection, acceptance, complications, reconnaissance, envelopment, and documentation (SACRED).

Infectious diseases affecting the small bowel - what not to miss.

PURPOSE OF REVIEW: This review summarizes infectious diseases involving the small bowel (SB) with a focus on recent literature related to diagnosis and pathophysiology. RECENT FINDINGS: Typical symptom for SB infections is diarrhea, mostly self-limiting. Pathogens include bacteria, viruses, fungi, protozoan parasites, and helminths. Host-pathogen interaction is of special interest in infections with potentially severe or prolonged course. Research uses increasingly enterocyte cell culture systems. SARS-CoV2 can also infect enterocytes via angiotensin converting enzyme 2 (ACE2) receptor and causes gastrointestinal complaints in some patients. Chronic SB infections as tuberculosis, Cytomegalovirus, or Epstein-Barr virus have to be differentiated from Crohn's and other diseases. Severe rare fungal and protozoan parasitic infections can cause relevant morbidity in immunocompromised patients. Soil-transmitted helminthic infections are a special issue in endemic areas. SUMMARY: Many infections involve the SB, typically causing mild and self-limiting diarrhea. Symptomatic therapy, hygiene, and isolation are the mainstay of management. However, some patients develop severe or chronic disease. Immunosuppression is a major cause for severe, but also for rare opportunistic systemic infections that can also affect the SB.

Feasibility and diagnostic yield of small-bowel capsule endoscopy in patients with surgically altered gastric anatomy: the SAGA study.

BACKGROUND AND AIMS: Little is known about small-bowel (SB) capsule endoscopy (CE) in patients with a history of gastric surgery. This study aims to evaluate the feasibility and diagnostic yield (DY) of orally ingested SB-CE in patients with surgically altered gastric anatomy. METHODS: Twenty-four European centers retrospectively identified patients who had SB-CE after total or subtotal gastrectomy. The primary outcome was the DY of SB-CE (intermediate P1 to highly P2 relevant findings). Secondary outcomes were gastric and SB transit times, completion, cleanliness, and adverse event rates. RESULTS: Studied were 248 procedures from 243 patients (mean age, 62 years) with a history of partial gastrectomy (Billroth I, 13.1%; Billroth II, 34.6%), total gastrectomy (7.4%), Whipple procedure (12.8%), sleeve gastrectomy (7.2%), or gastric bypass surgery (24.7%). Obscure GI bleeding was the most frequent indication (85.1%). SB completion rate was 84.3%. One capsule retention in the SB was noted (adverse event rate, .4%). Median SB transit time was 286 minutes (interquartile range [235; 387]). Cleanliness was rated as adequate in 92.1% of procedures. After exclusion of abnormalities found at the upper anastomotic site, the DY was 43.6%, with inflammatory/ulcerated lesions observed more frequently (23.4%) than vascular lesions (21.0%). CONCLUSIONS: SB-CE seems to be feasible and safe in selected patients with a history of major gastric surgery and comes with a high DY. The spectrum of abnormal SB findings in these patients may be different from what is known from the literature in nonoperated patients.

Implementation of European Society of Gastrointestinal Endoscopy (ESGE) recommendations for small-bowel capsule endoscopy into clinical practice: Results of an official ESGE survey.

BACKGROUND: We aimed to document international practices in small-bowel capsule endoscopy (SBCE), measuring adherence to European Society of Gastrointestinal Endoscopy (ESGE) technical and clinical recommendations. METHODS: Participants reached through the ESGE contact list completed a 52-item web-based survey. RESULTS: 217 responded from 47 countries (176 and 41, respectively, from countries with or without a national society affiliated to ESGE). Of respondents, 45 % had undergone formal SBCE training. Among SBCE procedures, 91 % were performed with an ESGE recommended indication, obscure gastrointestinal bleeding (OGIB), iron-deficiency anemia (IDA), and suspected/established Crohn's disease being the commonest and with higher rates of positive findings (49.4 %, 38.2 % and 53.5 %, respectively). A watchful waiting strategy after a negative SBCE for OGIB or IDA was preferred by 46.7 % and 70.3 %, respectively. SBCE was a second-line exam for evaluation of extent of new Crohn's disease for 62.2 % of respondents. Endoscopists adhered to varying extents to ESGE technical recommendations regarding bowel preparation ( > 60 %), use in those with pacemaker holders (62.5 %), patency capsule use (51.2 %), and use of a validated scale for bowel preparation assessment (13.3 %). Of the respondents, 67 % read and interpreted the exams themselves and 84 % classified exams findings as relevant or irrelevant. Two thirds anticipated future increase in SBCE demand. Inability to obtain tissue (78.3 %) and high cost (68.1 %) were regarded as the main limitations, and implementation of artificial intelligence as the top development priority (56.2 %). CONCLUSIONS: To some extent, endoscopists follow ESGE guidelines on using SBCE in clinical practice. However, variations in practice have been identified, whose implications require further evaluation.

Curriculum for small-bowel capsule endoscopy and device-assisted enteroscopy training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

The European Society of Gastrointestinal Endoscopy (ESGE) has recognized the need to formalize training in small-bowel endoscopy across European centers. The following criteria and framework for training in small-bowel capsule endoscopy (SBCE) and device-assisted enteroscopy (DAE), which aim to provide uniform and high quality training to ensure that small-bowel endoscopists are competent to operate independently, are based on the current literature and experience of experts in the field. Three main areas are covered: skills required prior to commencing training in small-bowel endoscopy; structured training for trainees to become independent endoscopists; and ways of ensuring competence is achieved. 1 : Centers providing training in SBCE should perform a minimum of 75 - 100 SBCEs/year. 2 : Experience in bidirectional endoscopies is desirable for structured training in SBCE. 3 : SBCE courses should consist of at least 50 % hands-on training and cover information on technology, indications and contraindications for SBCE, pathologies that can be encountered on SBCE, and standard terminology that should be used during reporting of SBCE. An SBCE course should be completed prior to achieving competence in SBCE reporting. 4 : Competence in SBCE can be assessed by considering a minimum of 30 SBCEs. Direct Observation of Procedural Skills, short SBCE videos, and multiple-choice questions can be useful to assess improvement in the skills of trainees. 5 : Centers offering training in DAE should aim to carry out at least 75 DAEs/year, should have direct links with an SBCE service, and should allow regular discussion of cases at a radiology small-bowel MDT. Training centers with lower numbers are encouraged to offer training by "buddying-up" with other centers, or using mentoring systems. 6 : DAE trainees must be independent in bidirectional endoscopies and have experience in level 1 polypectomy prior to commencement of training. They should also be competent in reviewing SBCEs. 7 : Training in DAE should be structured with a minimum of 75 procedures, including 35 retrograde DAEs, with therapeutic procedures undertaken in at least 50 % of the DAEs performed. Training should cover the indications, contraindications, complications including prevention, and technicalities of the DAE procedure; formal evaluation should follow. DAE trainees must acquire skills to independently manage and advise on small-bowel pathology following DAE procedures. 8 : It is highly recommended that international societies develop online modules and courses on DAE, which are currently lacking across Europe.

Small bowel ulcers: when is it not inflammatory bowel disease ?

PURPOSE OF REVIEW: Increasing use of small bowel endoscopy unravels ulcers in a relevant number of patients. Although often attributed to inflammatory bowel disease (IBD), these ulcers may be unspecific or caused by a variety of other diseases. This review summarizes the recent literature related to differential diagnosis of small bowel ulcers. RECENT FINDINGS: NSAID enteropathy is the major differential diagnosis to IBD in patients with small bowel ulcers. Intestinal tuberculosis must be considered in patients at risk. Rare causes for small bowel ulcers are autoinflammatory, neoplastic, vascular diseases, or nontuberculous infections. Morphology of small bowel ulcers cannot provide a reliable differentiation, and even histology is not specific in all cases. History with special focus on NSAID medication and clinical symptoms not typical for IBD, laboratory tests in the search of systemic disease, and microbiologic testing of biopsies can be helpful. Genetic testing allows identification of few rare entities like defects in prostaglandin metabolism. SUMMARY: Due to a massive overlap in the endoscopic appearance of small bowel ulcers between possible causes, diagnosis should be based on broad information also including history, histology, imaging, and laboratory tests.

Performance measures for small-bowel endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative.

The European Society of Gastrointestinal Endoscopy (ESGE) together with the United European Gastroenterology (UEG) recently developed a short list of performance measures for small-bowel endoscopy (i. e. small-bowel capsule endoscopy and device-assisted enteroscopy) with the final goal of providing endoscopy services across Europe with a tool for quality improvement. Six key performance measures for both small-bowel capsule endoscopy and for device-assisted enteroscopy were selected for inclusion, with the intention being that practice at both a service and endoscopist level should be evaluated against them. Other performance measures were considered to be less relevant, based on an assessment of their overall importance, scientific acceptability, and feasibility. Unlike lower and upper gastrointestinal endoscopy, where performance measures had already been identified, this is the first time that small-bowel endoscopy quality measures have been proposed.

[The revised version of standard terminology in gastroenterological endoscopy - result of a consensus project of the german society for gastroenterology, digestive and metabolic diseases]. / Neufassung der Standard-Terminologie in der gastroenterologischen Endoskopie ­ Ergebnis eines Konsensusprojekts der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten.

A uniform and comprehensive terminology is essential in the correct documentation of diagnostic or therapeutic endoscopic procedure. In the German-speaking world, the standard terminology available so far is based on a previous version published in 1999. Therefore, the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS) has undergone a comprehensive revision and re-structuring of the terminology. This appeared mandatory due to various changes, new diagnoses and new endoscopic procedures. The suggestions drawn up by individual working groups were approved by consensus and are now available as an online document (https://doi.org/10.1055/s-0043-121167) for modifying current software systems. In order to ensure an up-to-date documentation in the future, it was decided that annual updates will be performed by the DGVS to check respective software packages for modifications and new contents.

Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline.

This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). The Guideline was also reviewed and endorsed by the British Society of Gastroenterology (BSG). It addresses the roles of small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders. Main recommendations 1 ESGE recommends small-bowel video capsule endoscopy as the first-line investigation in patients with obscure gastrointestinal bleeding (strong recommendation, moderate quality evidence). 2 In patients with overt obscure gastrointestinal bleeding, ESGE recommends performing small-bowel capsule endoscopy as soon as possible after the bleeding episode, optimally within 14 days, in order to maximize the diagnostic yield (strong recommendation, moderate quality evidence). 3 ESGE does not recommend the routine performance of second-look endoscopy prior to small-bowel capsule endoscopy; however whether to perform second-look endoscopy before capsule endoscopy in patients with obscure gastrointestinal bleeding or iron-deficiency anaemia should be decided on a case-by-case basis (strong recommendation, low quality evidence). 4 In patients with positive findings at small-bowel capsule endoscopy, ESGE recommends device-assisted enteroscopy to confirm and possibly treat lesions identified by capsule endoscopy (strong recommendation, high quality evidence). 5 ESGE recommends ileocolonoscopy as the first endoscopic examination for investigating patients with suspected Crohn's disease (strong recommendation, high quality evidence). In patients with suspected Crohn's disease and negative ileocolonoscopy findings, ESGE recommends small-bowel capsule endoscopy as the initial diagnostic modality for investigating the small bowel, in the absence of obstructive symptoms or known stenosis (strong recommendation, moderate quality evidence).ESGE does not recommend routine small-bowel imaging or the use of the PillCam patency capsule prior to capsule endoscopy in these patients (strong recommendation, low quality evidence). In the presence of obstructive symptoms or known stenosis, ESGE recommends that dedicated small bowel cross-sectional imaging modalities such as magnetic resonance enterography/enteroclysis or computed tomography enterography/enteroclysis should be used first (strong recommendation, low quality evidence). 6 In patients with established Crohn's disease, based on ileocolonoscopy findings, ESGE recommends dedicated cross-sectional imaging for small-bowel evaluation since this has the potential to assess extent and location of any Crohn's disease lesions, to identify strictures, and to assess for extraluminal disease (strong recommendation, low quality evidence). In patients with unremarkable or nondiagnostic findings from such cross-sectional imaging of the small bowel, ESGE recommends small-bowel capsule endoscopy as a subsequent investigation, if deemed to influence patient management (strong recommendation, low quality evidence). When capsule endoscopy is indicated, ESGE recommends use of the PillCam patency capsule to confirm functional patency of the small bowel (strong recommendation, low quality evidence). 7 ESGE strongly recommends against the use of small-bowel capsule endoscopy for suspected coeliac disease but suggests that capsule endoscopy could be used in patients unwilling or unable to undergo conventional endoscopy (strong recommendation, low quality evidence).

AI-assisted capsule endoscopy reading in suspected small bowel bleeding: a multicentre prospective study.

BACKGROUND: Capsule endoscopy reading is time consuming, and readers are required to maintain attention so as not to miss significant findings. Deep convolutional neural networks can recognise relevant findings, possibly exceeding human performances and reducing the reading time of capsule endoscopy. Our primary aim was to assess the non-inferiority of artificial intelligence (AI)-assisted reading versus standard reading for potentially small bowel bleeding lesions (high P2, moderate P1; Saurin classification) at per-patient analysis. The mean reading time in both reading modalities was evaluated among the secondary endpoints. METHODS: Patients aged 18 years or older with suspected small bowel bleeding (with anaemia with or without melena or haematochezia, and negative bidirectional endoscopy) were prospectively enrolled at 14 European centres. Patients underwent small bowel capsule endoscopy with the Navicam SB system (Ankon, China), which is provided with a deep neural network-based AI system (ProScan) for automatic detection of lesions. Initial reading was performed in standard reading mode. Second blinded reading was performed with AI assistance (the AI operated a first-automated reading, and only AI-selected images were assessed by human readers). The primary endpoint was to assess the non-inferiority of AI-assisted reading versus standard reading in the detection (diagnostic yield) of potentially small bowel bleeding P1 and P2 lesions in a per-patient analysis. This study is registered with ClinicalTrials.gov, NCT04821349. FINDINGS: From Feb 17, 2021 to Dec 29, 2021, 137 patients were prospectively enrolled. 133 patients were included in the final analysis (73 [55%] female, mean age 66·5 years [SD 14·4]; 112 [84%] completed capsule endoscopy). At per-patient analysis, the diagnostic yield of P1 and P2 lesions in AI-assisted reading (98 [73·7%] of 133 lesions) was non-inferior (p<0·0001) and superior (p=0·0213) to standard reading (82 [62·4%] of 133; 95% CI 3·6-19·0). Mean small bowel reading time was 33·7 min (SD 22·9) in standard reading and 3·8 min (3·3) in AI-assisted reading (p<0·0001). INTERPRETATION: AI-assisted reading might provide more accurate and faster detection of clinically relevant small bowel bleeding lesions than standard reading. FUNDING: ANKON Technologies, China and AnX Robotica, USA provided the NaviCam SB system.

Updates in the diagnosis and management of small-bowel tumors.

Small-bowel tumors represent a rare entity comprising 0.6% of all new cancer cases in the US, and only 3% of all gastrointestinal neoplasms. They are a heterogenous group of neoplasms comprising of about forty different histological subtypes with the most common being adenocarcinoma, neuroendocrine tumors, stromal tumors and lymphomas. Their incidence has been reportedly increasing over recent years, partly owing to the advances and developments in the diagnostic modalities. Small-bowel capsule endoscopy, device assisted enteroscopy and dedicated small-bowel cross-sectional imaging are complimentary tools, supplementing each other in the diagnostic process. Therapeutic management of small-bowel tumors largely depends on the histological type and staging at diagnosis. The aim of the present review article is to discuss relevant advances in the diagnosis and management of small-bowel tumors.

Where does capsule endoscopy fit in the diagnostic algorithm of small bowel intussusception?

INTRODUCTION: The investigation of small bowel (SB) intussusception is variable, reflecting the lack of existing standards. The aim of this study was to understand the role of small bowel capsule endoscopy (SBCE) to investigate this pathology. METHODOLOGY: This was a retrospective multi-centre study. Patients with intussusception on SBCE and those where SBCE was carried out due to findings of intussusception on radiological investigations were included. Relevant information was collected. RESULTS: Ninety-five patients (median age 39+/-SD19.1 years, IQR 30) were included. Radiological investigations were carried out in 71 patients (74.7%) prior to SBCE with intussusception being present in 60 patients on radiological investigations (84.5%). Thirty patients (42.2%) had intussusception on radiological investigations followed by a normal SBCE. Ten patients (14.1%) had findings of intussusception on radiological investigations, a normal SBCE and repeat radiological investigations that were also normal. Abnormal findings were noted on SBCE that could explain intussusception on imaging in (16 patients) 22.5% of patients. Five patients (5.3%) underwent radiological investigations and SBCE to investigate coeliac disease and intussusception. None had associated malignancy. Four patients (4.2%) underwent SBCE to investigate familial polyposis syndromes and went on to SB enteroscopy and surgery accordingly. Most patients (n = 14; 14.8%) with intussusception on initial SBCE (without prior radiological imaging) had suspected SB bleeding (n = 10, 10.5%). Four patients (4.2%) had additional findings of a mass on CT scan and went on to have surgery. CONCLUSION: SBCE should be used to complement radiology when investigating intussusception. It is a safe non-invasive test that will minimise unnecessary surgery. Additional radiological investigations following a negative SBCE in cases of intussusception noted on initial radiological investigations are unlikely to yield positive findings. Radiological investigations following intussusception noted on SBCE in case of patients presenting with obscure gastrointestinal bleeding, may yield additional findings.

Capsule endoscopy versus colonoscopy for the detection of polyps and cancer.

BACKGROUND: An ingestible capsule consisting of an endoscope equipped with a video camera at both ends was designed to explore the colon. This study compared capsule endoscopy with optical colonoscopy for the detection of colorectal polyps and cancer. METHODS: We performed a prospective, multicenter study comparing capsule endoscopy with optical colonoscopy (the standard for comparison) in a cohort of patients with known or suspected colonic disease for the detection of colorectal polyps or cancer. Patients underwent an adapted colon preparation, and colon cleanliness was graded from poor to excellent. We computed the sensitivity and specificity of capsule endoscopy for polyps, advanced adenoma, and cancer. RESULTS: A total of 328 patients (mean age, 58.6 years) were included in the study. The capsule was excreted within 10 hours after ingestion and before the end of the lifetime of the battery in 92.8% of the patients. The sensitivity and specificity of capsule endoscopy for detecting polyps that were 6 mm in size or bigger were 64% (95% confidence interval [CI], 59 to 72) and 84% (95% CI, 81 to 87), respectively, and for detecting advanced adenoma, the sensitivity and specificity were 73% (95% CI, 61 to 83) and 79% (95% CI, 77 to 81), respectively. Of 19 cancers detected by colonoscopy, 14 were detected by capsule endoscopy (sensitivity, 74%; 95% CI, 52 to 88). For all lesions, the sensitivity of capsule endoscopy was higher in patients with good or excellent colon cleanliness than in those with fair or poor colon cleanliness. Mild-to-moderate adverse events were reported in 26 patients (7.9%) and were mostly related to the colon preparation. CONCLUSIONS: The use of capsule endoscopy of the colon allows visualization of the colonic mucosa in most patients, but its sensitivity for detecting colonic lesions is low as compared with the use of optical colonoscopy. (ClinicalTrials.gov number, NCT00604162.)

Score reproducibility and reliability in differentiating small bowel subepithelial masses from innocent bulges.

AIMS: The primary aim of this study was to assess the reliability, intra- and inter-observer variation of the SPICE, Mucosal protrusion angle (MPA) and SHYUNG scores in differentiating a subepithelial mass (SEM) from a bulge. METHODS: This retrospective multicentre study analysed the 3 scores, radiological studies, enteroscopy and/or surgical findings. RESULTS: 100 patients with a potential SEM (mean age 57.6years) were recruited with 75 patients having pathology. In patients with a SEM the mean SPICE score was 2.04 (95% CI 1.82-2.26) as compared to 1.16 (95% CI 0.81-1.51) without any pathology (AUC 0.74, p<0.001), with a fair intra-observer agreement (Kappa 0.3, p<0.001) and slight inter-observer agreement (Kappa 0.14, p<0.05). SPICE had a 37.3% sensitivity and 92.0% specificity in distinguishing between a SEM and bulge, whereas MPA<90˚ had 58.7% and 76.0% respectively, with poor intra-observer(p = 0.05) and interobserver agreement (p = 0.64). The SHYUNG demonstrated a moderate intra-observer (Kappa 0.44, p<0.001) and slight inter-observer reliability (Kappa 0.18, p<0.001). The sensitivity of an elevated SHYUNG score (≥4) in identifying a SEM was 18.7% with a specificity of 92.0% (AUC 0.71, p = 0.002). CONCLUSIONS: Though these scores are easy to use, they have, at best, slight to moderate intra and inter-observer agreement. Their overall diagnostic performances are limited.