A guide for assessing the clinical relevance of findings in small bowel capsule endoscopy: analysis of 8064 answers of international experts to an illustrated script questionnaire.

BACKGROUND AND AIM: Although recommended, the P-score used for assessing the pertinence / relevance of findings seen in small bowel (SB) capsule endoscopy (CE) is based on a low level of knowledge. The aim of this study was to evaluate the clinical relevance of the most frequent SBCE findings through an illustrated script questionnaire. MATERIALS AND METHODS: Sixteen types of SBCE findings were illustrated four times each in three different settings (occult and overt obscure gastrointestinal bleeding and suspected Crohn's disease), and with a variable number (n = 1/n = 2-5/n ≥ 6), thus providing a questionnaire with 192 scenarios and 576 illustrated questions. Fifteen international experts were asked to rate the finding's relevance for each question as very unlikely (-2) / unlikely (-1) / doubtful (0) / likely (+1) / very likely (+2). The median score (≤-0.75, between -0.75 and 0.75, or ≥0.75) obtained for each scenario determined a low (P0), intermediate (P1) or high (P2) relevance, respectively. RESULTS: 8064 answers were analyzed. Participation and completion rates were 93% and 100%, respectively. In overt or occult OGIB, resultant P2 findings were 'typical angiectasia', 'deep ulceration', 'stenosis', and'blood', whatever their numbers, and 'superficial ulcerations' when multiple. While in suspected CD, consensus P2 lesions were 'deep ulceration' and 'stenosis' whatever their numbers, and 'aphthoid erosions' and 'superficial ulcerations' when multiple. CONCLUSION: This study establishes a guide for the evaluation of relevance of SBCE findings. It represents a step forward for SB-CE interpretation and is intended to be used as a tool for teaching and academic research.

A Simple Evaluation Tool (ET-CET) Indicates Increase of Diagnostic Skills From Small Bowel Capsule Endoscopy Training Courses: A Prospective Observational European Multicenter Study.

Small bowel capsule endoscopy (SBCE) has become a first line diagnostic tool. Several training courses with a similar format have been established in Europe; however, data on learning curve and training in SBCE remain sparse.Between 2008 and 2011, different basic SBCE training courses were organized internationally in UK (n = 2), Italy (n = 2), Germany (n = 2), Finland (n = 1), and nationally in Germany (n = 10), applying similar 8-hour curricula with 50% lectures and 50% hands-on training. The Given PillCam System was used in 12 courses, the Olympus EndoCapsule system in 5, respectively. A simple evaluation tool for capsule endoscopy training (ET-CET) was developed using 10 short SBCE videos including relevant lesions and normal or irrelevant findings. For each video, delegates were required to record a diagnosis (achievable total score from 0 to 10) and the clinical relevance (achievable total score 0 to 10). ET-CET was performed at baseline before the course and repeated, with videos in altered order, after the course.Two hundred ninety-four delegates (79.3% physicians, 16.3% nurses, 4.4% others) were included for baseline analysis, 268 completed the final evaluation. Forty percent had no previous experience in SBCE, 33% had performed 10 or less procedures. Median scores for correct diagnosis improved from 4.0 (IQR 3) to 7.0 (IQR 3) during the courses (P < 0.001, Wilcoxon), and for correct classification of relevance of the lesions from 5.0 (IQR 3) to 7.0 (IQR 3) (P < 0.001), respectively. Improvement was not dependent on experience, profession, SBCE system, or course setting. Previous experience in SBCE was associated with higher baseline scores for correct diagnosis (P < 0.001; Kruskal-Wallis). Additionally, independent nonparametric partial correlation with experience in gastroscopy (rho 0.33) and colonoscopy (rho 0.27) was observed (P < 0.001).A simple ET-CET demonstrated significant improvement of diagnostic skills on completion of formal basic SBCE courses with hands-on training, regardless of preexisting experience, profession, and course setting. Baseline scores for correct diagnoses show a plateau after interpretation of 25 SBCE before courses, supporting this number as a compromise for credentialing. Experience in flexible endoscopy may be useful before attending an SBCE course.

Quantitative measurements in capsule endoscopy.

This review summarizes several approaches for quantitative measurement in capsule endoscopy. Video capsule endoscopy (VCE) typically provides wireless imaging of small bowel. Currently, a variety of quantitative measurements are implemented in commercially available hardware/software. The majority is proprietary and hence undisclosed algorithms. Measurement of amount of luminal contamination allows calculating scores from whole VCE studies. Other scores express the severity of small bowel lesions in Crohn׳s disease or the degree of villous atrophy in celiac disease. Image processing with numerous algorithms of textural and color feature extraction is further in the research focuses for automated image analysis. These tools aim to select single images with relevant lesions as blood, ulcers, polyps and tumors or to omit images showing only luminal contamination. Analysis of motility pattern, size measurement and determination of capsule localization are additional topics. Non-visual wireless capsules transmitting data acquired with specific sensors from the gastrointestinal (GI) tract are available for clinical routine. This includes pH measurement in the esophagus for the diagnosis of acid gastro-esophageal reflux. A wireless motility capsule provides GI motility analysis on the basis of pH, pressure, and temperature measurement. Electromagnetically tracking of another motility capsule allows visualization of motility. However, measurement of substances by GI capsules is of great interest but still at an early stage of development.

[Capsule Endoscopy in Patients with Cardiac Pacemakers and Implantable Cardioverter Defibrillators - Is the Formal Contraindication still Justified?]. / Kapselendoskopie bei Patienten mit Herzschrittmachern und implantierbaren Cardioverter-Defibrillatoren - Ist die formale Kontraindikation noch gerechtfertigt?

BACKGROUND AND AIMS: Capsule endoscopy is an established tool for investigation of the small intestine. Because of limited clinical experience in patients with cardiac devices the US Food and Drug Administration and the manufacturers recommend not to use capsule endoscopy in these patients. METHODS: Studies investigating possible interference between small bowel capsule endoscopy and cardiac pacemakers and implanted cardioverters were analysed. For the review we considered studies published in English or German and indexed in PubMed (Medline) as well as relevant abstracts and technical data from the manufacturer. RESULTS: In vitro and in vivo studies applying real capsules revealed no clinically relevant interference with pacemakers and implanted cardioverters. This evidence already has had an impact on clinical practice and recommendations of scientific societies. On the other hand wireless telemetry can interfere with CE video. CONCLUSION: According to present evidence, small bowel capsule endoscopy can be used in patients with pacemakers and implanted cardioverters after obtaining informed consent concerning the formal existence of contraindication.

Colon capsule endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

PillCam colon capsule endoscopy (CCE) is an innovative noninvasive, and painless ingestible capsule technique that allows exploration of the colon without the need for sedation and gas insufflation. Although it is already available in European and other countries, the clinical indications for CCE as well as the reporting and work-up of detected findings have not yet been standardized. The aim of this evidence-based and consensus-based guideline, commissioned by the European Society of Gastrointestinal Endoscopy (ESGE) is to furnish healthcare providers with a comprehensive framework for potential implementation of this technique in a clinical setting.

A pilot study evaluating a new low-volume colon cleansing procedure for capsule colonoscopy.

BACKGROUND AND STUDY AIMS: Colon capsule endoscopy (CCE) offers an alternative approach for endoscopic visualization of the colon. Some of the current CCE bowel cleansing regimens use sodium phosphate, which has raised safety concerns. Therefore, the aim of the current study was to test the feasibility and efficacy of a new low-volume, sodium phosphate-free polyethylene glycol (PEG) bowel preparation. METHODS: The first 26 patients (original cleansing procedure) received a colon cleansing regimen of PEG plus ascorbic acid: patients drank 1 L in the evening and 0.75 L in the morning before capsule ingestion. Patients also drank an additional 0.5 L PEG boost and an optional 0.25 L PEG boost during the capsule procedure. Following an interim analysis, the cleansing procedure of the subsequent 24 patients was modified, with the morning intake before capsule ingestion being increased to 1 L, as well as the second boost (0.25 L) being administered 1 - 2 hours earlier (modified cleansing procedure). RESULTS: The overall colon cleanliness was considered to be good or excellent in 83 % (original cleansing procedure) and 82 % (modified cleansing procedure) of patients, without any significant difference between regimens (P > 0.05). In 37 /49 (76 %) of the CCE procedures, the hemorrhoidal plexus was identified and thus the examination was considered complete, with no significant differences between the two CCE cleansing procedures. The capsule sensitivity and specificity for detecting colonic polyps ≥ 6 mm were 91 % (95 %CI 70 % - 98 %) and 94 % (95 %CI 87 % - 97 %), respectively, compared with standard optical colonoscopy. CONCLUSION: A colon cleansing procedure using PEG + ascorbic acid for capsule colonoscopy yielded an adequate cleansing level in > 80 % of patients, a completion rate of 76 %, and good accuracy for detecting polyps. This procedure may be considered as an alternative, particularly for patients in whom sodium phosphate-based preparations are contraindicated.

Role of small-bowel endoscopy in the management of patients with inflammatory bowel disease: an international OMED-ECCO consensus.

Crohn's disease and ulcerative colitis are lifelong diseases seen predominantly in the developed countries of the world. Whereas ulcerative colitis is a chronic inflammatory condition causing diffuse and continuous mucosal inflammation of the colon, Crohn's disease is a heterogeneous entity comprised of several different phenotypes, but can affect the entire gastrointestinal tract. A change in diagnosis from Crohn's disease to ulcerative colitis during the first year of illness occurs in about 10 % - 15 % of cases. Inflammatory bowel disease (IBD) restricted to the colon that cannot be characterized as either ulcerative colitis or Crohn's disease is termed IBD-unclassified (IBDU). The advent of capsule and both single- and double-balloon-assisted enteroscopy is revolutionizing small-bowel imaging and has major implications for diagnosis, classification, therapeutic decision making and outcomes in the management of IBD. The role of these investigations in the diagnosis and management of IBD, however, is unclear. This document sets out the current Consensus reached by a group of international experts in the fields of endoscopy and IBD at a meeting held in Brussels, 12-13th December 2008, organised jointly by the European Crohn's and Colitis Organisation (ECCO) and the Organisation Mondiale d'Endoscopie Digestive (OMED). The Consensus is grouped into seven sections: definitions and diagnosis; suspected Crohn's disease; established Crohn's disease; IBDU; ulcerative colitis (including ileal pouch-anal anastomosis [IPAA]); paediatric practice; and complications and unresolved questions. Consensus guideline statements are followed by comments on the evidence and opinion. Statements are intended to be read in context with qualifying comments and not read in isolation.

[Small bowel endoscopy]. / Endoskopie des Dünndarms.

Routine endoscopy of the small bowel has found its way into clinical practice within the last few years. Capsule endoscopy (CE) enables with high accuracy detection of the source of mid intestinal bleeding. Crohn's disease of the small bowel is sensitively detected and surveillance in polyposis syndromes is improved by applying sensitive, non-invasive endoscopic means. Double-balloon enteroscopy (DBE) may be used complementary to CE by offering therapeutic possibilities and providing histopathological specimen. This review describes the diagnostic and therapeutic repertoire that is offered by modern small bowel endoscopy.

Structured terminology for capsule endoscopy: results of retrospective testing and validation in 766 small-bowel investigations.

BACKGROUND AND STUDY AIMS: Capsule endoscopy (CE) is an effective means of investigating the small bowel in patients with gastrointestinal diseases. Computerized reports are frequently used in endoscopy, and the Minimal Standard Terminology (MST) has been promoted by endoscopy societies as the official vocabulary for endoscopy. The aims of this study were to design a lexicon for CE reports based on the principles of the MST and to validate lists of terms for describing findings and reasons for performing a CE by cross-matching them with the results of CE procedures collected during ongoing clinical studies. MATERIALS AND METHODS: A consensus-based Capsule Endoscopy Structured Terminology (CEST) was developed by experts involved in CE studies. Lists of terms suitable for CE were designed for the various sections of an endoscopic report. They were then correlated with the corresponding MST lists for duodenal and intestinal endoscopy. The results of 766 CE procedures, collected in an electronic case record form (eCRF), were analyzed to provide lists of reasons for performing the procedures and of the findings. The eCRF provided only a limited number of items for each data field, along with free-text facilities. Only descriptions pertaining to the small bowel were analyzed. Lists of terms were then reviewed by two experts to group obvious synonyms. The accuracy of the CEST was defined beforehand as the capability to describe 90 % of entries. RESULTS: A total of 766 CE procedures were analyzed. The eCRF included 824 entries as reasons for the examination in 655 CEs (1.3 per procedure). These represented 122 different expressions. After grouping of synonyms, 28 expressions remained. Among them, 10 were matched with terms from the list of reasons for performing CE offered in the CEST. These were the most frequently used, accounting for 768 entries in this field (93.2 %). All eCRFs contained at least one description of findings. A total of 109 CE procedures were classified as normal (14.3 %). A total of 2624 entries for abnormal findings were recorded for 657 procedures (4.0 per procedure). In all, 213 different expressions were used to describe abnormal findings. After grouping of synonyms, 52 expressions remained. Among these, 27 were matched with terms from the list of findings in the CEST, covering 2403 entries (91.6 %). CONCLUSIONS: In this study, CEST terms were capable of describing more than 90 % of the reasons for performance and of the findings in an unselected set of CE procedures. CEST is therefore suitable for use as the standard lexicon for CE reports. Adopted as a standard, it could significantly improve the quality of the data collected and reported in CE studies.

Small bowel endoscopy.

Video capsule endoscopy continues to be the major focus in papers dealing with diagnostic small-bowel endoscopy. Although capsule endoscopy is used for a variety of indications, its major field of application is still obscure bleeding from the small intestine, where it can be regarded as a first-line test. There is increasing evidence that capsule endoscopy for suspected Crohn's disease may be diagnostic in individual cases after inconclusive conventional tests. Push enteroscopy is the clinical reality for biopsy and treatment in the proximal small bowel, whereas intraoperative enteroscopy is used for distal or diffuse small-intestinal disorders. Further reports on double-balloon enteroscopy suggest that this method may be able to replace at least intraoperative enteroscopy in many circumstances. The availability of specific antibody tests for celiac disease is leading to recurrent interest in endoscopy and histology, showing that villous atrophy and lymphocytic infiltrates are typical, but not specific, findings.

Plasmapheresis in life-threatening verapamil intoxication.

Verapamil intoxications are life-threatening conditions with a far too often fatal outcome. In 2 patients, severe suicidal intoxication by 2.4 g and 9.6 g of verapamil orally resulted in life threatening hypotension and bradycardia with the need of heart-pacing and resuscitation. Plasmapheresis was started within less then 4 hours after intoxication and seemed to reduce the verapamil plasma concentration to less then 40%. A dramatic improvement of cardiovascular stability was already observed during plasmapheresis. In-vitro plasmapheresis was performed to verify the effectiveness of the extracorporeal detoxification. Verapamil was removed out of the blood by a clearance of 29.2 ml/min at blood flow of 200 ml/min. In conclusion, severe verapamil poisoning should be treated by early aggressive gut decontamination and an appropriate management of the haemodynamic complications. In case of lack of effectiveness for stabilisation, plasmapheresis can reduce verapamil related life threatening symptoms and bridge the time for the hepatic detoxification.

[Acute pancreatitis. Early elective endoscopic intervention]. / Akute Pankreatitis. Die früh-elektive endoskopische Intervention.

Early endoscopic intervention is required in the treatment of biliary pancreatitis in the presence of cholangitis or jaundice, possibly with dilated common bile duct. Also patients with predicted severe disease, lack of spontaneous clinical improvement or progressive jaundice might benefit from endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy. If endoscopy is indicated, it should be performed as soon as possible. Injection of contrast medium into a dilated bile duct is accompanied by the risk of cholangitis. Therefore therapeutic decompression by sphincterotomy and stone extraction is necessary, or, if this is not possible, insertion of a naso-biliary tube for drainage. Prophylactic use of antibiotics is recommended periinterventionally. Early endoscopic intervention is not necessary in patients with mild biliary pancreatitis and spontaneous clinical improvement. Here, ERCP can be performed later, if indicated.

Impact of profile haemodialysis on intra-/extracellular fluid shifts and the release of vasoactive hormones in elderly patients on regular dialysis treatment.

In 15 patients with end-stage renal failure and proven coronary heart disease, profile haemodialysis with decreasing ultrafiltration rate and hyperionic, decreasing dialysate solute concentration was compared with conventional, extracorporeal bicarbonate haemodialysis (Na+D = 138 mmol/l). Body fluid distribution and the release of vasoactive hormones (plasma renin activity, aldosterone, norepinephrine, epinephrine, and atrial natriuretic peptide) were investigated. Haemodialysis with constant ultrafiltration rate and constant dialysate composition (A) was followed by two dialysis profiles: decreasing ultrafiltration rate (B) and additional hyperionic, decreasing dialysate sodium concentration (C). In all 15 patients, the dialysis procedures (A) - (C) were used for 2 weeks each with six sessions, the last being taken for investigation. Body fluid distribution was calculated. In patients with serum sodium above 136 mmol/l, the conventional dialysis (A) as well as the Uf profile (B) showed a net fluid shift from extracellular volume (ECV) to intracellular volume (ICV). Using the profile with hyperionic, decreasing Na+D (C), the reverse fluid shift with decreasing ICV was achieved not only in those with serum Na+ <136 mmol/l, but also in those with serum Na+ > or = 136 mmol/l. The release of vasoactive hormones decreased already at profile haemodialysis (B) compared with (A) and was further reduced in (C). These results would suggest, profile dialyses B and C to have less impact on the cardiovascular system in elderly patients assuming higher patient comfort compared with the standard dialysis procedure. A higher benefit was obtained in C compared with B, presumably due to the additional prevention of the ICV shift and plasma volume depletion in patients with initial serum sodium > or = 136 mmol/l using transiently hyperionic Na+D. These results show that in elderly patients, hyperionic profile haemodialysis (Na+D > Na+S) had less impact on cardiovascular regulation than conventional bicarbonate dialysis.