Safety Of Capsule Endoscopy Research Articles

Multicenter prospective registration study of efficacy and safety of capsule endoscopy in Crohn’s disease in Japan (SPREAD-J study)

BackgroundEvidence of small-bowel capsule endoscopy (SBCE) for evaluating lesions in Crohn’s disease (CD) is lacking. We aimed to clarify the effectiveness and safety of SBCE in a large sample of patients with CD.MethodsThis multicenter prospective registration study recorded the clinical information and SBCE results of patients with definitive CD (d-CD) or suspected CD (s-CD). The primary outcomes were the rates of successful assessment of disease activity using SBCE, definitive diagnosis of CD, and adverse events. Secondary outcomes were the assessment of SBCE findings in patients with d-CD and s-CD and factors affecting SBCE incompletion and retention; and tertiary outcomes included the association between clinical disease activity or blood examination, endoscopic disease activity, ileal CD, and the questionnaire assessment of patient acceptance of SBCE.ResultsOf 544 patients analyzed, 541 underwent SBCE with 7 (1.3%) retention cases. Of 468 patients with d-CD, 97.6% could be evaluated for endoscopic activity. Of 76 patients with s-CD, 15.8% were diagnosed with ‘confirmed CD’. CD lesions were more frequently observed in the ileum and were only seen in the jejunum in 3.4% of the patients. Male sex and stenosis were risk factors for incomplete SBCE, and high C-reactive protein levels and stenosis were risk factors for capsule retention. In L1 (Montreal classification) patients, clinical remission was associated with endoscopic remission but showed low specificity and accuracy. The answers to the acceptability questionnaire showed the minimal invasiveness and tolerability of SBCE.ConclusionSBCE is practical and safe in patients with CD.

Efficacy and safety of capsule endoscopy in octogenarian patients: a retrospective study.

Life expectancy and the number of ultra-octogenarians increased significantly, thus making crucial the appropriateness of several endoscopic procedures in elderly patients. The aim of our study was to provide a retrospective analysis of the efficacy and safety of capsule endoscopy (CE) in patients aged over 80 years. In this single-centre study, 900 patients underwent capsule endoscopy between 2002 and 2015 for different indications; of these 106 patients aged ≥80 years (group A) and 99 patients aged 40-60 years (control group B) were retrospectively selected. Occult gastrointestinal bleeding accounted for 62.1% of all indications for capsule endoscopy in group B, compared to 95.2% in group A (P<0.001). Although not statistically significant, the diagnostic yield was higher in group A (71%) vs. group B (62%). The percentages of reaching the cecum and the median gastric transit time were uniform within the two groups. In contrast, small bowel transit time was longer in group A vs. B. Small bowel preparation was similar in the two groups. The exam was generally well tolerated in both groups, with capsule aspiration being one of the main adverse events, which occurred in two elderly patients. Our data expand previous findings confirming that capsule endoscopy can be performed safely even in very old patients and show that the diagnostic yield is similar to that of younger patients.

Indications for small bowel capsule endoscopy and its safety and diagnostic yield in Mexican patients. Experience at a tertiary care hospital center

IntroductionAppearing in the year 2000, capsule endoscopy revolutionized the study of the small bowel. It is the gold standard for the study of small bowel bleeding and is considered a safe procedure. ObjectiveThe aim of the present study was to identify the indications for, diagnostic yield, and safety of capsule endoscopy in Mexican patients. Materials and methodsA descriptive study was conducted on the first 500 small bowel capsule endoscopies performed at a tertiary care hospital center in Mexico City. Sex, age, type of video camera employed, bowel transit time, referral diagnosis, and capsule endoscopy findings and complications were registered. ResultsMean patient age was 55years (±17.63) and 57.9% of the cases were women. Complete visualization of the small bowel was achieved in 420 capsule endoscopies (84%). Mean bowel transit time was 272.25minutes (±114.86). The most common indications for the procedure were small bowel bleeding (65.2%), search for neoplasia (14.4%), and Crohn's disease (10.2%). The presence of ulcers was the most common finding in small bowel bleeding (24.8%), followed by angioectasias (18.9%). Capsule retention was the only complication and it presented in 11 patients (2.2%). ConclusionsCapsule endoscopy is a safe and efficacious method for studying the small bowel. The results obtained in Mexican patients were similar to those described in the international literature. The present case series is the largest reported in a Mexican population.

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

AIMTo analyze the diagnostic yield (DY), therapeutic impact (TI) and safety of capsule endoscopy (CE).METHODSThis 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.RESULTSThe 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.CONCLUSIONCE 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.

Time Series Analysis of the Effectiveness and Safety of Capsule Endoscopy between the Premarketing and Postmarketing Settings: A Meta-Analysis.

BackgroundClinical studies for assessing the effectiveness and safety in a premarketing setting are conducted under time and cost constraints. In recent years, postmarketing data analysis has been given more attention. However, to our knowledge, no studies have compared the effectiveness and the safety between the pre- and postmarketing settings. In this study, we aimed to investigate the importance of the postmarketing data analysis using clinical data.Methods and FindingsStudies on capsule endoscopy with rich clinical data in both pre- and postmarketing settings were selected for the analysis. For effectiveness, clinical studies published before October 10, 2015 comparing capsule endoscopy and conventional flexible endoscopy measuring the detection ratio of obscure gastrointestinal bleeding were selected (premarketing: 4 studies and postmarketing: 8 studies) from PubMed (MEDLINE), Cochrane Library, EMBASE and Web of Science. Among the 12 studies, 5 were blinded and 7 were non-blinded. A time series meta-analysis was conducted. Effectiveness (odds ratio) decreased in the postmarketing setting (premarketing: 5.19 [95% confidence interval: 3.07–8.76] vs. postmarketing: 1.48 [0.81–2.69]). The change in odds ratio was caused by the increase in the detection ratio with flexible endoscopy as the control group. The efficacy of capsule endoscopy did not change between pre- and postmarketing settings. Heterogeneity (I2) increased in the postmarketing setting because of one study. For safety, in terms of endoscope retention in the body, data from the approval summary and adverse event reports were analyzed. The incidence of retention decreased in the postmarketing setting (premarketing: 0.75% vs postmarketing: 0.095%). The introduction of the new patency capsule for checking the patency of the digestive tract might contribute to the decrease.ConclusionsEffectiveness and safety could change in the postmarketing setting. Therefore, time series meta-analyses could be useful to continuously monitor the effectiveness of medical device in clinical practices.

Lack of interference between small bowel capsule endoscopy and implantable cardiac defibrillators: an 'invivo' electrophysiological study.

Capsule endoscopy is a widely performed procedure for small bowel investigation. Once swallowed by the patient, the capsule transmits images to an external recorder over a digital radiofrequency communication channel. Potential electromagnetic interferences with implantable cardiac devices have been postulated. Clinical studies on the safety of capsule endoscopy in patients with cardiac defibrillators are lacking. The aim of this study was to assess potential mutual electromagnetic interferences between capsule and defibrillators. This study used the Given M2A video capsule system. Ten different types of defibrillators were tested in a clinical setting. Before capsule ingestion, defibrillator electrical therapies were switched off. During capsule endoscopy patients were monitored with cardiac telemetry. At the end of capsule endoscopy the following defibrillator's parameters were analysed: change in device settings; inappropriate shocks; inappropriate anti-tachycardia therapy; inappropriate sensing or pacing; noise detection; device reset; programming changes; permanent electrical damages. Any technical problem related to capsule image transmission was recorded. Neither defibrillator malfunction nor interference in sensing or pacing was recorded; conversely, no capsule malfunction potentially caused by defibrillators was registered. Our results suggest that capsule endoscopy can be safely performed in patients with cardiac defibrillators.

Tu1149 Clinical Impact and Safety of Capsule Endoscopy in Patients With Established Crohn's Disease -A Multicenter Cross-Sectional Study

readers using the MaRIA index and CDEIS, respectively. A MaRIA subsegment score >11 and CDEIS >8 were used as selection criteria demonstrating active disease for inclusion into a study of moderate to severely active CD. Results: A total of 19 patients were enrolled across the six centers. Using ileocolonoscopy as the standard reference, MRE without enema identified deep ulcers in the colon with 58% sensitivity, 73% specificity; MRE with enema had similar sensitivity, 58% but better specificity, 80%. For enrollment into a trial for moderate to severely active CD, the CDAI identified 6 patients. Of these, only 3 patients had active disease confirmed by either MRE or Ileocolonoscopy. One of these three patients had an abscess identified by MRE. The remaining three patients had no objective evidence of disease by MRE or ileocolonoscopy. Using MRE, 12 subjects were identified for inclusion into a trial of which 3 would have been excluded from a clinical trial due to presence of an abscess or abdominal extramedullary hematopoeisis. Two of the remaining 9 subjects did not have identifiable disease on ileocolonoscopy. Using ileocolonoscopy, 6 subjects were identified of whom 2 patients would have been excluded by MRE due to an abscess. Overall, MRE selected 7 patients with active disease compared with 4 and 2 patients by CDEIS and CDAI who would be appropriate to include in a CD clinical trial. Conclusions: In comparison to endoscopy and the CDAI, MRE better enriches for patients with more appropriate levels of disease for inclusion in a clinical trial with therapeutic intervention.

DOP032 Clinical impact and safety of capsule endoscopy in patients with established Crohn's disease – a multicenter cross-sectional study

DOP032 Clinical impact and safety of capsule endoscopy in patients with established Crohn's disease – a multicenter cross-sectional study

Safety of capsule endoscopy in the octogenarian as compared with younger patients

There has been an increased use of capsule endoscopy for the evaluation of small-intestine pathology in very elderly patients, yet the safety profile of this procedure has not been well-established. To estimate the adverse event rate of capsule endoscopy in patients aged ≥80 years and to compare this rate with that of capsule endoscopy patients aged <80 years. Retrospective matched cohort study. Single tertiary-care referral center. All 195 patients aged ≥80 years who underwent capsule endoscopy between 2005 and 2011 were included, along with 585 capsule endoscopy patients aged <80 years who were matched by sex in a 1:3 fashion. All patients underwent capsule endoscopy and, in selected cases, double-balloon enteroscopy. Adverse event rate of capsule endoscopy, which was defined as capsule retention or aspiration. Adverse events occurred at a similar frequency in patients aged ≥80 years compared with those aged <80 years (1.03% vs 0.85%; P = 1.00), resulting in a difference of 0.2% (95% confidence interval, -1.8% to 2.1%). All adverse events were related to capsule retention, with no study patients experiencing aspiration. This was a single-center, retrospective study. Adverse events resulting from capsule endoscopy occur at a similar rate in patients aged ≥80 years compared with those aged <80 years. Capsule endoscopy can be performed safely in the very elderly patient population.

The application of capsule endoscopy in the digestive tract disease of 55 cases

Objective To analyze the clinical value and safety of capsule endoscopy in the digestive tract diseases.Methods 55 cases of inpatients or outpatients were given the capsule endoscopy examination.The positive detection rate and safety were observed.Results The positive detection rate was 87.3％,the diagnostic rate was 50.9％.Capsule retention in the body happened in 2 cases (1 case of small intestine space-occupying lesions,decided to take the operation,another 1 case got Crohn's disease,intestinal incomplete obstruction),the occurrence rate was 1.5％.Conclusion The capsule endoscopy make up some shortcomings of the traditional gastrointestinal endoscope,but also show some drawbacks,so improving performance of instrument of the capsule endoscopy,expanding the scope of application of capsule endoscopy will be the development direction of the capsule endoscopy in the future. Key words: Capsule endoscopy; Digestive tract

Does the Beat Go On? Does the Video Still Play? Results from the Largest Series to Date on the Safety of Capsule Endoscopy in Patients with Implantable Cardiac Devices

Purpose: Studies to date suggest that video capsule endoscopy (CE) is safe and associated with few adverse events. A concern, which has not been extensively studied, is the capsule's potential adverse effect on implantable cardiac devices, and conversely, cardiac device-mediated interference of images acquired by CE. This is particularly important in the elderly, because CE is most often performed for occult gastrointestinal bleeding, a condition not uncommon in this group who also have the most number of implantable cardiac devices. The primary aim of this study is to evaluate the safety of CE in patients with implanted electromedical cardiac devices and the secondary aim was to determine whether the implantable cardiac devices had any effect on the images captured by the capsule. Methods: A retrospective chart review was performed of all patients who underwent a CE and had implantable cardiac devices - cardiac pacemakers (PM), implantable cardiac defibrillators (ICD) or left ventricular assist device (LVAD) - at Mayo Clinic Arizona and Mayo Clinic Rochester. Data points collected include demographics, indication for CE, pre- and post-procedure cardiac assessments, quality of CE study with particular reference to technical difficulties or interference with video imaging, and if CE was complete to the cecum. Results: Ninety-one capsule studies were reviewed (N=84 pts; 67%M). The average age of the population studied was 73.1 yrs. Average BMI was 27.7 kg/m2. Patients most commonly had PMs (69.2%), followed by ICDs (25.3%), LVAD (3.3%), LVAD+ICD (1.1%) and LVAD + PM (1.1%). The indication for CE in order of frequency was gastrointestinal bleeding (73.6%), anemia (15.4%), abdominal pain (6.6%), celiac disease (2.2%), diarrhea (1.1%), and Crohn's disease (1.1%). CE reached the cecum in 62.6% of the patients. Quality of preparation was available on only 70/91 CEs and was rated fair to excellent in 48.4%. Post procedure assessments did not reveal any interference on the implanted cardiac device. Only 1 patient with an ICD had a 25 minute loss of capsule imaging that resumed when the capsule device recorder was replaced. Conclusion: This study represents the largest known series to date of the impact of CE on cardiac devices and vice versa. Performance of CE in patients with cardiac devices including LVADs appears safe. Conversely, the implanted cardiac devices in general do not interfere with CE images. Disclosure: Dr Jonathan Leighton,Research support Given Imaging and Olympus. Consulting for Given Imaging and Intromedic Dr Lucinda A. Harris - No conflicts Dr Stephanie Hansel - No conflicts Dr Elizabeth Rajan- No conflicts Dr Komandoor Srivathasan - No conflicts Dr Surya Gurudu - No Conflicts Dr Virender K. Sharma - Consulting - EnteroMedic Dr Michael D. Crowell No conflicts Dr Robert Rea - No conflicts Ms. Janice K. Post - Consulting Given Imaging Debbra K. Stark - No conflicts.

Safety of Capsule Endoscopy in the Setting of Implanted Cardiac Defibrillators: A Brief Report

1Division of Gastroenterology, Department of Medicine, Roger William Medical Center, School of Medicine, Boston University, Providence, Rhode Island, USA. Correspondence: Georg Elias, MD, Division of Gastroenterology, Department of Medicine, Roger William Medical Center, School of Medicine, Boston University, 825 Chalkstone Avenue, Providence, Rhode Island 02908, USA. E-mail: [email protected] Meeting presentation: DDW 2008. San Diego, CA May 21st, poster presentation. published online 12 May 2009

The Diagnostic Effect of Capsule Endoscopy in 31 Cases with Subacute Small Bowel Obstruction

AIM: To evaluate the effectiveness and safety of capsule endoscopy (CE) in patients with recurrent subacute small bowel obstruction.

Capsule Endoscopy in Patients with Low Neutrophil Count and Evidence of Gastrointestinal Bleeding

Background and Aim: The utility and safety of capsule endoscopy (CE) in patients with low neutrophil count and gastrointestinal bleeding is unknown. The aim of this study was to determine the yield and safety of CE in this patient population. Methods: A retrospective analysis of 225 patients who underwent CE at M.D. Anderson Cancer Center from July 2005 thru September 2008. Patients with gastrointestinal bleeding who had an absolute neutrophil count (ANC) <1500 cells/μL during the time of capsule endoscopy were identified.

Diagnostic effect of capsule endoscopy in 31 cases of subacute small bowel obstruction

To evaluate the effectiveness and safety of capsule endoscopy (CE) in patients with recurrent subacute small bowel obstruction. The study was a retrospective analysis of 31 patients referred to hospital from January 2003 to August 2008 for the investigation of subacute small bowel obstruction, who underwent CE. The patients were aged 9-81 years, and all of them had undergone gastroscopy and colonoscopy previously. Some of them received abdominal computed tomography or small bowel follow-through. CE made a definitive diagnosis in 12 (38.7%) of 31 cases: four Crohn's disease (CD), two carcinomas, one intestinal tuberculosis, one ischemic enteritis, one abdominal cocoon, one duplication of the intestine, one diverticulum and one ileal polypoid tumor. Capsule retention occurred in three (9.7%) of 31 patients, and was caused by CD (2) or tumor (1). Two with retained capsules were retrieved at surgery, and the other one of the capsules was spontaneously passed the stricture by medical treatment in 6 mo. No case had an acute small bowel obstruction caused by performance of CE. CE provided safe and effective visualization to identify the etiology of a subacute small bowel obstruction, especially in patients with suspected intestinal tumors or CD, which are not identified by routine examinations.

Effectiveness and Safety of Capsule Endoscopy in the Diagnosis of Small Bowel Diseases

To assess the effectiveness, safety, and clinical use of capsule endoscopy (CE) in the diagnosis of small bowel diseases. Systematic review carried out in the main electronic databases, including MEDLINE, EMBASE, and COCHRANE. Papers were selected independently by the 2 researchers and the quality was determined using a purpose-designed scale. A total of 9 systematic reviews and 28 original papers were included [11 assessed obscure gastrointestinal bleeding, 9 Crohn's disease (CD), and 4 hereditary polyposis syndromes]. The diagnostic yield of CE for the diagnosis of obscure gastrointestinal bleeding ranged from 39% to 77%. The diagnostic yield of push enteroscopy was lower than 40% in all but 1 study. CE detected suggestive findings in 19% to 71% of patients with suspected CD, whereas radiologic techniques did so in only 0% to 37% of the cases. In patients with suspected recurrence, detection with these techniques was 58% to 81% and 19% to 67%, respectively. Endoscopic capsule detected a greater number of polyps in patients with polyposis syndromes but other techniques allowed for better localization. Although CE occupies a preferential place in the diagnosis of gastrointestinal bleeding and CD; there is insufficient evidence to establish whether it could be used as a first line diagnostic test. The evidence is insufficient to ascertain this technique's usefulness in small bowel disorders other than obscure bleeding or CD.

Screening and surveillance for hereditary polyposis and non-polyposis syndromes with capsule endoscopy

The hereditary polyposis syndromes and non-polyposis colorectal carcinoma have been considered as scarcely occurring but inheritable dominant autosomal syndromes. The increasing risk of small bowel carcinoma and prevention of obstruction and intussusception have been making frequent and acute surgical interventions unavoidably led to the necessity of screening and surveillance the patients. Earlier the diagnosis of these symptoms was difficult to establish because traditional radiological methods have a low yield for small polyps. Furthermore, small bowel is only partially accessible with traditional endoscopic techniques such as upper endoscopy, colonoscopy and push-enteroscopy. The "wireless" capsule endoscopy has opened the way then for the non-invasive and painless test of the entire small intestine. - Test results have been cumulated to justify the efficiency and safety of capsule endoscopy concerning the syndromes above. This method can be applied safely even consequently to repeatedly performed surgical interventions by low risk of capsule retention. As the results compared of the diagnosed familial adenomatous polyposis and of Peutz-Jeghers syndrome reflect on capsule endoscopy, its diagnostic sensitiveness is stated as significantly higher than the Barium-contrast X-Ray and MR-enterography. Nevertheless, determination of size and location of polyps has become more problematic when evaluating the test results.

Safety of Capsule Endoscopy in the Setting of Implanted Cardiac Defibrillators, Two Years Experience

Background: Video capsule endoscopy (CE) is a helpful diagnostic tool. There is a hypothetical potential for interference between the digital radiofrequency of the capsule and an implantable cardiac defibrillator (ICD). Because of this concern and the U.S. Food and Drug Administration (FDA) recommendations, the manufacturer (Given) has listed the presence of an implanted cardiac device as a relative contraindication to the use in the presence of ICD. Aim: To report the use of wireless video capsule endoscopy (Given®) in four patients with implanted cardiac defibrillators.

Capsule endoscopy

Over the past 6 years or more, capsule endoscopy has emerged as a success story, not only in terms of its development for a variety of different indications and its use in different sites in the gastrointestinal tract, but also in that it has stimulated our thoughts on the optimal modern endoscopic work-up for each specific indication. This year at Digestive Disease Week there were around 77 abstracts concerned with capsule endoscopy. These included reports on the usefulness and safety of capsule endoscopy in different clinical situations, including obscure bleeding (for which capsule endoscopy now forms the basis of clinical management), Crohn’s disease, and the detection of small-bowel tumors (which can probably be regarded as a difficult application of capsule endoscopy); reports on topics specific to capsule endoscopy, such as the rationale for small-bowel preparation, the development of new capsules, technical (biochromoendoscopy) and software developments; and abstracts on the development of capsules designed specifically for different sites in the gastrointestinal tract (e. g. the Pillcam ESO in esophageal portal hypertension and the newer colon capsules). These numerous and interesting reports not only demonstrate the influence of capsule endoscopy on clinical management, but they also throw light on conventional endoscopy practices, including the rapid development of double-balloon enteroscopy, and the ongoing intense debate surrounding new methods for colonic neoplasia screening.

Safety of Capsule Endoscopy After Patency Capsule in Small Bowel Crohn's Disease

Safety of Capsule Endoscopy After Patency Capsule in Small Bowel Crohn's Disease