Endoscopic management of subepithelial lesions including neuroendocrine neoplasms: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

1: ESGE recommends endoscopic ultrasonography (EUS) as the best tool to characterize subepithelial lesion (SEL) features (size, location, originating layer, echogenicity, shape), but EUS alone is not able to distinguish among all types of SEL.Strong recommendation, moderate quality evidence. 2: ESGE suggests providing tissue diagnosis for all SELs with features suggestive of gastrointestinal stromal tumor (GIST) if they are of size > 20 mm, or have high risk stigmata, or require surgical resection or oncological treatment.Weak recommendation, very low quality evidence. 3: ESGE recommends EUS-guided fine-needle biopsy (EUS-FNB) or mucosal incision-assisted biopsy (MIAB) equally for tissue diagnosis of SELs ≥ 20 mm in size.Strong recommendation, moderate quality evidence. 4: ESGE recommends against surveillance of asymptomatic gastrointestinal (GI) tract leiomyomas, lipomas, heterotopic pancreas, granular cell tumors, schwannomas, and glomus tumors, if the diagnosis is clear.Strong recommendation, moderate quality evidence. 5: ESGE suggests surveillance of asymptomatic esophageal and gastric SELs without definite diagnosis, with esophagogastroduodenoscopy (EGD) at 3-6 months, and then at 2-3-year intervals for lesions < 10 mm in size, and at 1-2-year intervals for lesions 10-20 mm in size. For asymptomatic SELs > 20 mm in size that are not resected, ESGE suggests surveillance with EGD plus EUS at 6 months and then at 6-12-month intervals.Weak recommendation, very low quality evidence. 6: ESGE recommends endoscopic resection for type 1 gastric neuroendocrine neoplasms (g-NENs) if they grow larger than 10 mm. The choice of resection technique should depend on size, depth of invasion, and location in the stomach.Strong recommendation, low quality evidence. 7: ESGE suggests considering removal of histologically proven gastric GISTs smaller than 20 mm as an alternative to surveillance. The decision to resect should be discussed in a multidisciplinary meeting. The choice of technique should depend on size, location, and local expertise.Weak recommendation, very low quality evidence. 8: ESGE suggests that, to avoid unnecessary follow-up, endoscopic resection is an option for gastric SELs smaller than 20 mm and of unknown histology after failure of attempts to obtain diagnosis.Weak recommendation, very low quality evidence. 9: ESGE recommends basing the surveillance strategy on the type and completeness of resection. After curative resection of benign SELs no follow-up is advised, except for type 1 gastric NEN for which surveillance at 1-2 years is advised.Strong recommendation, low quality evidence. 10: For lower or upper GI NEN with a positive or indeterminate margin at resection, ESGE recommends repeating endoscopy at 3-6 months and another attempt at endoscopic resection in the case of residual disease.Strong recommendation, low quality evidence.

Endoscopic Ultrasound-Guided Fine Needle Biopsy Using 22-Gauge Franseen Needle for the Histological Diagnosis of Solid Lesions: A Multicenter Prospective Pilot Study.

BACKGROUND: Recently, a novel 22-gauge needle with three symmetric needle points and crown-shaped cutting heels, known as a Franseen needle, has been developed for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB). AIM: To assess the histological material acquisition rate and histological diagnostic capability of the 22-gauge Franseen needle (AC22) during EUS-FNB for solid lesions. METHODS: This study was designed as an open-label, multicenter, prospective, single-arm pilot study of EUS-FNB using AC22 for the diagnosis of solid lesions. Three passes of FNB using AC22 were performed for all lesions. The primary endpoints were the histological material acquisition rate and histological diagnostic capability. The secondary endpoints were the technical success rate, quality of histological samples, number of passes for diagnosis, and safety. RESULTS: Between September 2017 and May 2018, 75 patients were enrolled. The final diagnoses were malignancy in 65 and benign in 10. Three passes of FNB were technically successful in all patients. The sensitivity, specificity, and accuracy for the malignancy of histological analyses were 92.3% (60/65), 100% (10/10), and 93.3% (70/75), respectively, for the first pass and 95.4% (62/65), 100% (10/10), and 96% (72/75), respectively, for combined three passes. The diagnostic yield plateaued after the second pass. Sufficient tissue samples for histological interpretation were obtained in 96% (72/75) and 100% (75/75) patients for the single pass and combined three passes, respectively. Two patients (2.7%) developed mild pancreatitis as an adverse event. CONCLUSION: EUS-FNB using AC22 showed high histological diagnostic capability with the high first pass yield. CLINICAL TRIALS REGISTRY: UMIN Clinical Trials Registry (UMIN ID: UMIN000036641).

Management of rectal cancer in Canada: an evidence-based comparison of clinical practice guidelines

Background: Rectal cancer requires a multidisciplinary and multimodality treatment approach. Clinical practice guidelines (CPGs) provide a framework for delivering consistent, evidence-based health care. We compared provincial/territorial CPGs across Canada to identify areas of variability and evaluate their quality. Methods: We retrieved CPGs from Canadian organizations responsible for cancer care oversight and evaluated their quality and developmental methodology using the AGREE-II instrument. Recommendations for diagnostic and staging investigations, treatment by stage, and post-treatment surveillance of stage I­III rectal cancers were abstracted and compared. Results: We identified 7 sets of CPGs for analysis, varying in content, presentation, quality, and year last updated. Differences were noted in locoregional staging: 4 recommended magnetic resonance imaging over endorectal ultrasonography, 2 recommended either modality, and 3 specified scenarios for one over the other. Recommendations also varied for use of staging computed tomography of the chest versus chest radiography and for surgical management and indications for transanal excision. Recommendations for neoadjuvant therapy in stage II/III disease also differed: 3 guidelines recommended long-course chemoradiation over short-course radiation therapy alone, while 3 others recommended short-course radiation in specific clinical scenarios. Adjuvant chemotherapy for stage II/III disease was uniformly recommended, with variable protocols. The use of proctosigmoidoscopy and interval/duration of endoscopic post-treatment surveillance varied among guidelines. Conclusion: Canadian CPGs vary in their recommendations for staging, treatment, and surveillance of rectal cancer. Some of these differences reflect areas with limited definitive evidence. Consistent guidelines with uniform implementation across provinces/territories may lead to more equitable care to patients.

Contexte: Le cancer rectal requiert une approche thérapeutique multidisciplinaire et multimodalité. Les guides de pratique clinique (GPC) procurent un cadre pour assurer la prestation de soins de santé constants reposant sur des données probantes. Nous avons comparé les GPC des provinces et des territoires canadiens pour identifier les secteurs où ils varient et pour en évaluer la qualité. Méthodes: Nous avons obtenu les GPC des organisations canadiennes responsables des soins oncologiques et nous avons évalué leur qualité et la méthodologie de leur élaboration au moyen de l'outil AGREE II (Appraisal of Guidelines for Research & Evaluation). Nous avons extrait et comparé les recommandations en ce qui concerne les épreuves diagnostiques et la stadification, les traitements en fonction du stade et la surveillance post-thérapeutique du cancer rectal de stade I à III. Résultats: Nous avons recensé 7 GPC aux fins de cette analyse; leur contenu, leur présentation, leur qualité et l'année de leur plus récente mise à jour variaient. Des différences ont été observées au plan de la stadification locorégionale : 4 recommandaient l'imagerie par résonnance magnétique plutôt que l'échographie endorectale, 2 recommandaient l'une ou l'autre et 3 précisaient des circonstances où utiliser l'une plutôt que l'autre. Les recommandations variaient aussi pour ce qui est de l'utilisation de la scintigraphie c. radiographie thoracique de stadification, de la prise en charge chirurgicale et des indications de l'excision transanale. Les recommandations variaient également en ce qui concerne le traitement néoadjuvant pour la maladie de stade II/III : 3 guides recommandaient un traitement par chimioradiothérapie à long terme plutôt qu'une brève radiothérapie seule, tandis que 3 autres recommandaient une radiothérapie brève dans certains cas particuliers. La chimiothérapie adjuvante pour la maladie de stade II/III était uniformément recommandée, mais les protocoles variaient. L'utilisation de la proctosigmoïdoscopie et l'intervalle/durée de la surveillance endoscopique post-thérapeutique variaient d'un guide à l'autre. Conclusion: Les GPC canadiens varient quant à leurs recommandations pour la stadification, le traitement et la surveillance du cancer rectal. Certaines de ces différences témoignent du manque de données probantes concluantes dans certains secteurs. L'uniformisation des guides et de leur application entre les provinces et les territoires pourrait faciliter une prestation plus équitable des soins aux patients.

[Accuracy comparision of abdominal enhanced CT and endoscopic ultrasound in the staging of gastric cancer after neoadjuvant chemotherapy: a post hoc analysis of a randomized clinical trial].

Objective: To compare the accuracy of abdominal enhanced CT and endoscopic ultrasound in the staging of gastric cancer after neoadjuvant chemotherapy (yc stage). Methods: Clinic data of 86 locally advanced gastric cancer patients admitted in Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute from April 2015 to November 2017 were analyzed retrospectively. Totally 86 patients completed both abdominal enhanced CT and endoscopic ultrasound after neoadjuvant chemotherapy. There were 60 males and 26 females, aged (57.8±9.7) years (range: 32 to 76 years). The diagnostic accuracy of abdominal enhanced CT and endoscopic ultrasound for yc stage were calculated by the area under the multiclass receiver operation characteristic curve (M-AUC), retrospectively. McNemar test was used to compared the diagnostic sensitivity. Results: The M-AUC of ycT stage evaluated by abdominal enhanced CT (CT-ycT stage) and by endoscopic ultrasound (EUS-ycT stage) was 0.614 and 0.704, respectively. For middle and lower gastric cancer, the M-AUC of CT-ycT stage was 0.599 and 0.613, respectively, while EUS-ycT stage was 0.558 and 0.709, respectively. For tumor in the lesser and non-lesser curvature, the M-AUC of CT-ycT stage was 0.630 and 0.607, respectively, while EUS-ycT stage was 0.616 and 0.749, respectively. For patients in CT-ycT1-CT-ycT4, there was no statistically significant difference in the sensitivity between CT-ycT stage and EUS-ycT stage (2/18, 2/15, 52.8%(19/36), 8/13 vs. 0, 4/15, 55.6%(20/36), 7/13; χ(2)=2.00, P=0.157; χ(2)=2.00, P=0.157; χ(2)=0.08, P=0.782; χ(2)=0.33, P=0.564). The M-AUC of ycN stage evaluated by abdominal enhanced CT (CT-ycN stage) was 0.654, while ycN stage evaluated by endoscopic ultrasound (EUS-ycN stage) was 0.533. For patients in CT-ycN0, there was statistically significant difference in the sensitivity between CT-ycN stage and EUS-ycN stage (12.7%(7/55) vs. 5.5%(3/55); χ(2)=4.00, P=0.046). For patients in CT-ycN1, N2, and N3, there was no statistically significant difference in the sensitivity between CT-ycN stage and EUS-ycN stage (2/19, 1/10, 0 vs. 1/19, 1/10, 0; χ(2)=1.00, P=0.317; the other P cannot be estimated). Conclusions: There was no significant difference between the diagnostic efficacy of abdominal enhanced CT and endoscopic ultrasound for yc stage of gastric cancer. Considering the invasiveness of ultrasound gastroscopy, it should not be recommend for patients after neoadjuvant chemotherapy routinely.

Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography, From Training Through Independent Practice.

BACKGROUND & AIMS: It is unclear whether participation in competency-based fellowship programs for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) results in high-quality care in independent practice. We measured quality indicator (QI) adherence during the first year of independent practice among physicians who completed endoscopic training with a systematic assessment of competence. METHODS: We performed a prospective multicenter cohort study of invited participants from 62 training programs. In phase 1, 24 advanced endoscopy trainees (AETs), from 20 programs, were assessed using a validated competence assessment tool. We used a comprehensive data collection and reporting system to create learning curves using cumulative sum analysis that were shared with AETs and trainers quarterly. In phase 2, participating AETs entered data into a database pertaining to every EUS and ERCP examination during their first year of independent practice, anchored by key QIs. RESULTS: By the end of training, most AETs had achieved overall technical competence (EUS 91.7%, ERCP 73.9%) and cognitive competence (EUS 91.7%, ERCP 94.1%). In phase 2 of the study, 22 AETs (91.6%) participated and completed a median of 136 EUS examinations per AET and 116 ERCP examinations per AET. Most AETs met the performance thresholds for QIs in EUS (including 94.4% diagnostic rate of adequate samples and 83.8% diagnostic yield of malignancy in pancreatic masses) and ERCP (94.9% overall cannulation rate). CONCLUSIONS: In this prospective multicenter study, we found that although competence cannot be confirmed for all AETs at the end of training, most meet QI thresholds for EUS and ERCP at the end of their first year of independent practice. This finding affirms the effectiveness of training programs. Clinicaltrials.gov ID NCT02509416.

Factors leading to failure to diagnose pulmonary malignant tumors using endobronchial ultrasound with guide sheath within the target lesion.

BACKGROUND: The diagnostic yield of peripheral pulmonary lesions has significantly increased with the use of radial endobronchial ultrasound with guide sheath within the lesion. Here, we retrospectively evaluated factors leading to misdiagnosis of pulmonary malignant tumors using endobronchial ultrasound with the guide sheath within the lesion. METHODS: We assessed the final histopathological diagnosis of biopsy samples taken from 130 patients with lung malignant tumors that underwent endobronchial ultrasound with guide sheath within the lesion. RESULTS: Among 130 patients, 8 (6%) showed no definite malignant findings in biopsy samples but the presence of malignant cells (primary lung cancer 7, diffuse large B cell lymphoma 1) was subsequently confirmed by histopathological study of specimens taken by computed tomography-guided needle biopsy or surgery. Of the eight cases with diagnostic failure, the size of the biopsy sample was insufficient in five due to technical difficulties during the diagnostic procedure, and the diagnosis of malignant tumor was difficult in five cases because of extensive scarring tissue or central necrosis. CONCLUSIONS: The results of this study showed that technical difficulties and/or pathological heterogeneity of the tumor might lead to failure to diagnose lung malignant tumor in cases using endobronchial ultrasound with guide sheath within the lesion.

Is endoscopic ultrasonography more sensitive than magnetic resonance imaging in detecting and localizing pancreatic neuroendocrine tumors?

To compare endoscopic ultrasonography (EUS) and magnetic resonance imaging (MRI) in terms of their sensitivities to localize pancreatic neuroendocrine tumors (pNET) preoperatively. Systematic analysis of the literature; sensitivity of EUS and MRI in insulinomas and pancreaticoduodenal NETs in multiple endocrine neoplasia type 1 (MEN1) in series of at least 20 subjects referring to tumors confirmed by surgery and histopathology. Other imaging methods reported were also assessed. Eighteen publications on insulinomas (782 cases) could be analyzed, no study in MEN1 fulfilled the inclusion criteria and compared EUS to MRI. Data quality was moderate: all publications referred to case series. Mean correct detection / localization rates (sensitivity) were calculated: EUS 80%, MRI 66%, computed tomography 63%, angiography 52%, somatostatin receptor scintigraphy 42%, ultrasonography 23%; arterial calcium stimulation with hepatic venous sampling regionalized correctly in 80%. EUS seems to be more sensitive than MRI in localizing pancreatic neuroendocrine tumors. If a specialized endosonographist is available, EUS is the preferable imaging procedure. Otherwise, MRI is a suitable alternative.

Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative.

The European Society of Gastrointestinal Endoscopy and United European Gastroenterology present a short list of key performance measures for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP). We recommend that endoscopy services across Europe adopt the following seven key and one minor performance measures for EUS and ERCP, for measurement and evaluation in daily practice at center and endoscopist level: 1: Adequate antibiotic prophylaxis before ERCP (key performance measure, at least 90 %); 2: Antibiotic prophylaxis before EUS-guided puncture of cystic lesions (key performance measure, at least 95 %); 3: Bile duct cannulation rate (key performance measure, at least 90 %); 4: Tissue sampling during EUS (key performance measure, at least 85 %); 5: Appropriate stent placement in patients with biliary obstruction below the hilum (key performance measure, at least 95 %); 6: Bile duct stone extraction (key performance measure, at least 90 %); 7: Post-ERCP pancreatitis (key performance measure, less than 10 %). 8: Adequate documentation of EUS landmarks (minor performance measure, at least 90 %).This present list of quality performance measures for ERCP and EUS recommended by ESGE should not be considered to be exhaustive: it might be extended in future to address further clinical and scientific issues.

Colonoscopy Surveillance After Colorectal Cancer Resection: Recommendations of the US Multi-Society Task Force on Colorectal Cancer.

The US Multi-Society Task Force has developed updated recommendations to guide health care providers with the surveillance of patients after colorectal cancer (CRC) resection with curative intent. This document is based on a critical review of the literature regarding the role of colonoscopy, flexible sigmoidoscopy, endoscopic ultrasound, fecal testing and CT colonography in this setting. The document addresses the effect of surveillance, with focus on colonoscopy, on patient survival after CRC resection, the appropriate use and timing of colonoscopy for perioperative clearing and for postoperative prevention of metachronous CRC, specific considerations for the detection of local recurrence in the case of rectal cancer, as well as the place of CT colonography and fecal tests in post-CRC surveillance.

EUS and related technologies for the diagnosis and treatment of pancreatic disease: research gaps and opportunities-Summary of a National Institute of Diabetes and Digestive and Kidney Diseases workshop.

A workshop was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases to address the research gaps and opportunities in pancreatic EUS. The event occurred on July 26, 2017 in 4 sessions: (1) benign pancreatic diseases, (2) high-risk pancreatic diseases, (3) diagnostic and therapeutics, and (4) new technologies. The current state of knowledge was reviewed, with identification of numerous gaps in knowledge and research needs. Common themes included the need for large multicenter consortia of various pancreatic diseases to facilitate meaningful research of these entities; to standardize EUS features of different pancreatic disorders, the technique of sampling pancreatic lesions, and the performance of various therapeutic EUS procedures; and to identify high-risk disease early at the cellular level before macroscopic disease develops. The need for specialized tools and accessories to enable the safe and effective performance of therapeutic EUS procedures also was discussed.

Pediatric gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) and European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) Guideline Executive summary.

This Executive summary of the Guideline on pediatric gastrointestinal endoscopy from the European Society of Gastrointestinal Endoscopy (ESGE) and the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) refers to infants, children, and adolescents aged 0 - 18 years. The areas covered include: indications for diagnostic and therapeutic esophagogastroduodenoscopy and ileocolonoscopy; endoscopy for foreign body ingestion; endoscopic management of corrosive ingestion and stricture/stenosis; upper and lower gastrointestinal bleeding; endoscopic retrograde cholangiopancreatography, and endoscopic ultrasonography. Percutaneous endoscopic gastrostomy and endoscopy specific to inflammatory bowel disease (IBD) have been dealt with in other Guidelines and are therefore not mentioned in this Guideline. Training and ongoing skill maintenance will be addressed in an imminent sister publication.

The cut-off value of tumor size and appropriate timing of follow-up for management of minimal EUS-suspected gastric gastrointestinal stromal tumors.

BACKGROUD: The detectable rate of minimal gastric GISTs has continuously increased. While the surveillance and management of GIST <2 cm have been deemed controversial or lack evidence-based approaches.  The aim of the current study is to propose a cut-off value of tumor size for treatment policy and the appropriate timing for endoscopic ultrasonography (EUS) follow-up in the minimal EUS-suspected gastric GIST patients. METHODS: A single-institution retrospective study was performed. 69 patients with EUS-suspected gastric GISTs were studied from November 2008 to March 2015. 69 patients with minimal gastric GISTs ≤2 cm diagnosed by EUS were followed for a mean period of 29 months (range, 12 to 70). An at least 20% increase of the maximal diameter of the tumors was set as a significant change. RESULTS: During follow-up, Of the 69 minimal EUS-suspected GISTs, 16 (23.2%) showed significant changes in size. 11 out of 69 GISTs (15.9%), 6 out of 43 GISTs (14.0%), 7 out of 30 GISTs (23.3%) showed significant changes in size, at 1 year, 2 years, and more than 3 years respectively. The receiver operating characteristic curve analysis showed that the tumor size cut-off was 9.5 mm. Only 4.7 and 3.7% of gastric EUS-suspected GISTs of <9.5 mm in size showed significant changes at 1 year and 2 years, while 9.5% at more than 3 years. 34.6, 31.3 and 55.6% of gastric EUS-suspected GISTs of ≥ 9.5 mm in size showed significant changes at 1 year, 2 years and more than 3 years. CONCLUSIONS: Minimal EUS-suspected GISTs, larger than 9.5 mm may be associated with significant progression. The patients with a ≥ 9.5 mm GIST should have a EUS 6-12months, while <9.5 mm GIST may have a EUS extended to every 2-3 years.

Is Transducer Hygiene sufficient when Vaginal Probes are used in the Clinical Routine?

Vaginal ultrasound probes are semi-critical Group A medical products which must be disinfected following the manufacturer's instructions after every patient examination. According to the "Essential Requirements for Medical Devices (Directive 93/42/EEC, Annex I, paragraph 13)" the manufacturer's instructions for use for reusable products must contain suitable instructions for preparation processes. This presumes both an effective and material-compatible method. Evidence of effectiveness must be validated.In the Editorial in issue 1 Ultraschall in der Medizin/European Journal of Ultrasound 2005 we discussed the topic of transducer hygiene and stated that proper handling and cleaning as well as disinfection of probes in daily use are indispensable. This applies particularly to vaginal ultrasound probes routinely used in gynecological and obstetrical clinics, gynecological practices as well as IVF centers Normally the probe used in a transvaginal ultrasound examination is covered with a latex protective cover (with CE marking) which contains a certain amount of ultrasound gel. After the examination, the cover is removed and disposed of, and the gel is removed from the transducer. Since handling of the probe, ultrasound gel and cover can result in smear infections and cross-contamination with various pathogens (e. g. MRSA, HBV, HCV, HIV, herpes papilloma and cytomegalic viruses), after the protective cover is removed, the probe must be cleaned and subjected to disinfection with a bactericidal, fungicidal and virucidal effect. This is especially important in the event the cover ruptures during the vaginal examination, and the probe comes into direct contact with vaginal secretions or blood. The same likewise applies if the sterile protective cover is perforated during a follicular puncture. Usually special bactericidal, levurocidal and virucidal wipes or special submersion disinfection methods are available for disinfecting the vaginal ultrasound probes 11. Using special virucidal wipes on the probes is considered low-level disinfection. Primarily quaternary ammonia compounds are employed for this procedure. This method is easily applicable, has good cleaning characteristics, is effective against HPV and has high skin tolerance. However, it has the disadvantage of not removing all microorganisms during the disinfection process. Immersion procedures are high-level disinfection methods during which the transducer head is dipped in a special fluid for a certain amount of time. The disinfectants used for this include e. g. preparations based on glutaraldehyde or succinic aldehyde. However, in practice immersion disinfection has a number of disadvantages 13: 1. The procedure cannot be validated. 2. The probe permanently attached to the device must be placed in a separate holder and disinfected for at least 15 minutes. This is impracticable in routine operations in a clinic, outpatient facility or practice with a high number of examinations. 3. After this disinfection method, the probe has to be thoroughly rinsed with potable or higher-quality water in order to remove remnants of allergenic or locally toxic substances. 4. Frequently examinations take place in small interior areas with poor ventilation, thus under some circumstances posing an inhalant-related health hazard. 5. The required virucidal effect is frequently not achieved within 15 minutes 13. Furthermore, extended probe contact with liquid disinfecting agents in the long run results in increased wear of the transducer head membrane.Therefore it was interesting to note that in 2009 a fully-automatic disinfection system for ultrasound probes was introduced to the market (Trophon(EPR). This product, developed in Australia, promised relatively rapid high-level disinfection (HLD). During this software-controlled, mechanical disinfection procedure, the entire ultrasound probe (transducer head and handle) is placed in a sealed disinfection chamber, then hydrogen peroxide (H2O2) is discharged as an anti-microbial aerosol into the closed chamber.  The ultra-fine mist wets the entire surface of the probe with H2O2, thereby achieving high-level disinfection of the entire ultrasound probe. At the end of the process, a catalytic decomposition system breaks down the H2O2 into environmentally-friendly oxygen and water. When the chamber is opened, the probe is dry and ready for immediate use. The fully-automatic device was designed as a table unit to be placed directly next to the ultrasound equipment so that the probe does not need to be disconnected from the base unit. The entire disinfection process lasts 7 minutes: 2 minutes for the application and 5 minutes to remove the aerosol residue. In a validation study using carrier tests, Heeg and Gauer in 2014 showed that this procedure genuinely achieved HLD of ultrasound probes within 7 minutes, thus making it suitable for daily clinical routine. The procedure fulfills all requirements for HLD based on the medical device classification according to the legally-prescribed recommendation of the Commission for Hospital Hygiene and Prevention of Infection and the Federal Institute for Drugs and Medical Products (KRINKO/BfArM) in Germany. In the USA, this method was approved by the FDA as well as the leading probe manufacturers, and bears the testing certificate of the German Society for Hospital Hygiene (DGKH).All in all, it should be stated that the sole use of a latex protective cover when using a vaginal probe does not meet the necessary standard of care required for the provision of semi-critical medical products according to the joint recommendation of the German Federal Institute for Drugs and Medical Products (BfArM) and Commission for Hospital Hygiene and Prevention of Infection of the Robert Koch Institute, and constitutes a contravention of necessary patient and user protections. Use of the protective cover does not rule out smear infections and cross-contamination; therefore after each examination, the probe, after removal of the cover, must undergo disinfection measures providing bactericidal, fungicidal and virucidal effects. Since the transducer handle also poses a significant risk of transmission of germs, this component must likewise be sufficiently disinfected. In the event of perforation or rupture of the latex cover, thus resulting in the probe coming into contact with vaginal secretions or blood, the probe must be not only cleaned, but effectively disinfected with a virucide as well. It should also be noted that infection by bacteria and viruses can be caused not only by a contaminated probe, but by the ultrasound gel as well. According to studies by Heeg and Gauer 15, Buescher et al. as well as Ryndock et al., the fully automatic HLD system operated with hydrogen peroxide is currently the only validated system proven to provide HLD of ultrasound probes in a 7-minute cycle, thus suitable for application in the daily routine. Likewise it can also be presumed that this procedure also offers good material compatibility.

Endoscopic ultrasound versus magnetic resonance cholangiopancreatography for common bile duct stones.

BACKGROUND: Endoscopic ultrasound (EUS) and magnetic resonance cholangiopancreatography (MRCP) are tests used in the diagnosis of common bile duct stones in patients suspected of having common bile duct stones prior to undergoing invasive treatment. There has been no systematic review of the accuracy of EUS and MRCP in the diagnosis of common bile duct stones using appropriate reference standards. OBJECTIVES: To determine and compare the accuracy of EUS and MRCP for the diagnosis of common bile duct stones. SEARCH METHODS: We searched MEDLINE, EMBASE, Science Citation Index Expanded, BIOSIS, and Clinicaltrials.gov until September 2012. We searched the references of included studies to identify further studies and of systematic reviews identified from various databases (Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment (HTA), Medion, and ARIF (Aggressive Research Intelligence Facility)). We did not restrict studies based on language or publication status, or whether data were collected prospectively or retrospectively. SELECTION CRITERIA: We included studies that provided the number of true positives, false positives, false negatives, and true negatives for EUS or MRCP. We only accepted studies that confirmed the presence of common bile duct stones by extraction of the stones (irrespective of whether this was done by surgical or endoscopic methods) for a positive test, and absence of common bile duct stones by surgical or endoscopic negative exploration of the common bile duct or symptom free follow-up for at least six months for a negative test, as the reference standard in people suspected of having common bile duct stones. We included participants with or without prior diagnosis of cholelithiasis; with or without symptoms and complications of common bile duct stones, with or without prior treatment for common bile duct stones; and before or after cholecystectomy. At least two authors independently screened abstracts and selected studies for inclusion. DATA COLLECTION AND ANALYSIS: Two authors independently collected the data from each study. We used the bivariate model to obtain pooled estimates of sensitivity and specificity. MAIN RESULTS: We included a total of 18 studies involving 2366 participants (976 participants with common bile duct stones and 1390 participants without common bile duct stones). Eleven studies evaluated EUS alone, and five studies evaluated MRCP alone. Two studies evaluated both tests. Most studies included patients who were suspected of having common bile duct stones based on abnormal liver function tests; abnormal transabdominal ultrasound; symptoms such as obstructive jaundice, cholangitis, or pancreatitis; or a combination of the above. The proportion of participants who had undergone cholecystectomy varied across studies. Not one of the studies was of high methodological quality. For EUS, the sensitivities ranged between 0.75 and 1.00 and the specificities ranged between 0.85 and 1.00. The summary sensitivity (95% confidence interval (CI)) and specificity (95% CI) of the 13 studies that evaluated EUS (1537 participants; 686 cases and 851 participants without common bile duct stones) were 0.95 (95% CI 0.91 to 0.97) and 0.97 (95% CI 0.94 to 0.99). For MRCP, the sensitivities ranged between 0.77 and 1.00 and the specificities ranged between 0.73 and 0.99. The summary sensitivity and specificity of the seven studies that evaluated MRCP (996 participants; 361 cases and 635 participants without common bile duct stones) were 0.93 (95% CI 0.87 to 0.96) and 0.96 (95% CI 0.90 to 0.98). There was no evidence of a difference in sensitivity or specificity between EUS and MRCP (P value = 0.5). From the included studies, at the median pre-test probability of common bile duct stones of 41% the post-test probabilities (with 95% CI) associated with positive and negative EUS test results were 0.96 (95% CI 0.92 to 0.98) and 0.03 (95% CI 0.02 to 0.06). At the same pre-test probability, the post-test probabilities associated with positive and negative MRCP test results were 0.94 (95% CI 0.87 to 0.97) and 0.05 (95% CI 0.03 to 0.09). AUTHORS' CONCLUSIONS: Both EUS and MRCP have high diagnostic accuracy for detection of common bile duct stones. People with positive EUS or MRCP should undergo endoscopic or surgical extraction of common bile duct stones and those with negative EUS or MRCP do not need further invasive tests. However, if the symptoms persist, further investigations will be indicated. The two tests are similar in terms of diagnostic accuracy and the choice of which test to use will be informed by availability and contra-indications to each test. However, it should be noted that the results are based on studies of poor methodological quality and so the results should be interpreted with caution. Further studies that are of high methodological quality are necessary to determine the diagnostic accuracy of EUS and MRCP for the diagnosis of common bile duct stones.

Diagnostic accuracy of endoscopic ultrasonography (EUS) for the preoperative locoregional staging of primary gastric cancer.

BACKGROUND: Endoscopic ultrasound (EUS) is proposed as an accurate diagnostic device for the locoregional staging of gastric cancer, which is crucial to developing a correct therapeutic strategy and ultimately to providing patients with the best chance of cure. However, despite a number of studies addressing this issue, there is no consensus on the role of EUS in routine clinical practice. OBJECTIVES: To provide both a comprehensive overview and a quantitative analysis of the published data regarding the ability of EUS to preoperatively define the locoregional disease spread (i.e., primary tumor depth (T-stage) and regional lymph node status (N-stage)) in people with primary gastric carcinoma. SEARCH METHODS: We performed a systematic search to identify articles that examined the diagnostic accuracy of EUS (the index test) in the evaluation of primary gastric cancer depth of invasion (T-stage, according to the AJCC/UICC TNM staging system categories T1, T2, T3 and T4) and regional lymph node status (N-stage, disease-free (N0) versus metastatic (N+)) using histopathology as the reference standard. To this end, we searched the following databases: the Cochrane Library (the Cochrane Central Register of Controlled Trials (CENTRAL)), MEDLINE, EMBASE, NIHR Prospero Register, MEDION, Aggressive Research Intelligence Facility (ARIF), ClinicalTrials.gov, Current Controlled Trials MetaRegister, and World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), from 1988 to January 2015. SELECTION CRITERIA: We included studies that met the following main inclusion criteria: 1) a minimum sample size of 10 patients with histologically-proven primary carcinoma of the stomach (target condition); 2) comparison of EUS (index test) with pathology evaluation (reference standard) in terms of primary tumor (T-stage) and regional lymph nodes (N-stage). We excluded reports with possible overlap with the selected studies. DATA COLLECTION AND ANALYSIS: For each study, two review authors extracted a standard set of data, using a dedicated data extraction form. We assessed data quality using a standard procedure according to the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) criteria. We performed diagnostic accuracy meta-analysis using the hierarchical bivariate method. MAIN RESULTS: We identified 66 articles (published between 1988 and 2012) that were eligible according to the inclusion criteria. We collected the data on 7747 patients with gastric cancer who were staged with EUS. Overall the quality of the included studies was good: in particular, only five studies presented a high risk of index test interpretation bias and two studies presented a high risk of selection bias.For primary tumor (T) stage, results were stratified according to the depth of invasion of the gastric wall. The meta-analysis of 50 studies (n = 4397) showed that the summary sensitivity and specificity of EUS in discriminating T1 to T2 (superficial) versus T3 to T4 (advanced) gastric carcinomas were 0.86 (95% confidence interval (CI) 0.81 to 0.90) and 0.90 (95% CI 0.87 to 0.93) respectively. For the diagnostic capacity of EUS to distinguish T1 (early gastric cancer, EGC) versus T2 (muscle-infiltrating) tumors, the meta-analysis of 46 studies (n = 2742) showed that the summary sensitivity and specificity were 0.85 (95% CI 0.78 to 0.91) and 0.90 (95% CI 0.85 to 0.93) respectively. When we addressed the capacity of EUS to distinguish between T1a (mucosal) versus T1b (submucosal) cancers the meta-analysis of 20 studies (n = 3321) showed that the summary sensitivity and specificity were 0.87 (95% CI 0.81 to 0.92) and 0.75 (95% CI 0.62 to 0.84) respectively. Finally, for the metastatic involvement of lymph nodes (N-stage), the meta-analysis of 44 studies (n = 3573) showed that the summary sensitivity and specificity were 0.83 (95% CI 0.79 to 0.87) and 0.67 (95% CI 0.61 to 0.72), respectively.Overall, as demonstrated also by the Bayesian nomograms, which enable readers to calculate post-test probabilities for any target condition prevalence, the EUS accuracy can be considered clinically useful to guide physicians in the locoregional staging of people with gastric cancer. However, it should be noted that between-study heterogeneity was not negligible: unfortunately, we could not identify any consistent source of the observed heterogeneity. Therefore, all accuracy measures reported in the present work and summarizing the available evidence should be interpreted cautiously. Moreover, we must emphasize that the analysis of positive and negative likelihood values revealed that EUS diagnostic performance cannot be considered optimal either for disease confirmation or for exclusion, especially for the ability of EUS to distinguish T1a (mucosal) versus T1b (submucosal) cancers and positive versus negative lymph node status. AUTHORS' CONCLUSIONS: By analyzing the data from the largest series ever considered, we found that the diagnostic accuracy of EUS might be considered clinically useful to guide physicians in the locoregional staging of people with gastric carcinoma. However, the heterogeneity of the results warrants special caution, as well as further investigation for the identification of factors influencing the outcome of this diagnostic tool. Moreover, physicians should be warned that EUS performance is lower in diagnosing superficial tumors (T1a versus T1b) and lymph node status (positive versus negative). Overall, we observed large heterogeneity and its source needs to be understood before any definitive conclusion can be drawn about the use of EUS can be proposed in routine clinical settings.

Staging accuracy of endoscopic ultrasound performed by nonexpert endosonographers in patients with resectable esophageal squamous cell carcinoma: is it possible?

The accuracy of endoscopic ultrasound (EUS) is operator-dependent. According to learning curve study, the accuracy of EUS T-staging for esophageal cancer has been reported to be greater in an investigator who had performed at least 100 EUS examinations. We determined comparative study regarding T-staging accuracy of EUS for esophageal squamous cell carcinoma between expert and nonexpert endoscopic ultrasonographers. We retrospectively identified 73 consecutive patients with esophageal squamous cell carcinoma who underwent EUS and endoscopic mucosal resection, endoscopic submucosal dissection, or surgery. EUS was performed by expert (Group 1) and nonexpert (Group 2) endoscopic ultrasonographers in multitertiary hospitals. Groups 1 and 2 were 37 and 36 patients during 2005-2011, respectively. Forty-two patients (57.5%) of the overall patients underwent surgical exploration. Correct endoscopic ultrasonographic T-staging of Group 1 was observed in 34 (91.9%) patients, while that of Group 2 was observed in 26 (72.2%) patients. And there was significant difference in correct endoscopic ultrasonographic T-staging between Group 1 and Group 2 (P = 0.035). The incorrect endoscopic ultrasonographic T-staging of Group 1 were three cases that were overstaging (8.1%), but in Group 2 there were seven overstaging (19.4%) and three understaging (8.3%). There was no significant difference in overstaging or understaging of incorrect endoscopic ultrasonographic T-staging between Group 1 and Group 2 (P = 0.528). This study first provides evidence that endoscopic ultrasonographic T-staging of nonexpert endoscopic ultrasonographers was inferior to be correct, compared with that of expert endoscopic ultrasonographers. EUS staging for esophageal cancer should be performed by expert endoscopic ultrasonographers to provide appropriate management strategy.

Development and validation of a theoretical test in endosonography for pulmonary diseases.

BACKGROUND: Theoretical testing provides the necessary foundation to perform technical skills. Additionally, testing improves the retention of knowledge. OBJECTIVES: The aims of this study were to develop a multiple-choice test in endosonography for pulmonary diseases and to gather validity evidence for this test. METHODS: Initially, 78 questions were constructed after informal conversational interviews with 4 international experts in endosonography. The clarity and content validity of the questions were tested using a Delphi-like approach. Construct validity was explored by administering the test to 3 groups with different levels of endosonography experience: 27 medical students, 18 respiratory physicians with limited endosonography experience, and 14 experts in endosonography. RESULTS: Two Delphi iterations reduced the test to 52 questions. After item analysis, the final test consisted of 46 questions with a mean item discrimination of 0.47 and a mean item difficulty of 0.63. The internal consistency reliability was calculated at 0.91. The 3 groups performed significantly differently (ANOVA: p < 0.001), and post hoc tests were significant. The experts performed significantly more consistently than the novices (p = 0.037) and the intermediates (p < 0.001). CONCLUSIONS: This study provides a theoretical test in endosonography consisting of multiple-choice questions. Validity evidence was gathered, and the test demonstrated content and construct validity.

Sonohysterography in peri- and postmenopausal women with abnormal uterine bleeding or abnormal endometrial appearance.

OBJECTIVES: To assess the usefulness of SIS and to compare its diagnostic accuracy with conventional transvaginal ultrasound (TVS) and hysteroscopy (HSC) to detect intracavitary abnormalities in peri- and postmenopausal women with abnormal endometrial appearance or abnormal uterine bleeding (AUB) prior to admission. DESIGN AND SETTING: The study group consisted of 40 patients in peri- and postmenopausal period referred to the 1st Department of Obstetrics and Gynecology, Medical University of Warsaw due to AUB or abnormal endometrial appearance on TVS between January 2013 and June 2013. All the participants underwent TVS followed by SIS in order to plan further management. Only the patients with uterine abnormalities on TVS examination, proved by SIS were qualified for HSC. Hysteroscopical guided biopsies were taken in cases with focal lesions. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of TVS, SIS and HSC were calculated by comparison with the final pathological diagnosis as the gold standard. RESULTS: The comparison of the three diagnostic procedures revealed that the diagnostic accuracy of SIS and HSC is superior to conventional TVS. SIS and HSC had identical accuracy for submucosal myomas (PPV and NPV 1.0 for both), while in case of polypoid lesions the accuracy of HSC was higher than of SIS (HSC: PPV 0.8, NPV 1.0; SIS: PPV 0.75; NPV 0.75). CONCLUSIONS: Due to its accuracy and cost-effectiveness, SIS could be regarded as a primary diagnostic method allowing proper qualification for further invasive diagnostic or therapeutic procedures in the detection of uterine abnormalities among peri- and postmenopausal women.

Complications and management of interventional endoscopic ultrasound: A critical review.

In the last decades, Endoscopic ultrasound (EUS) has rapidly grown and evolved from being mainly a diagnostic procedure, to being an interventional and therapeutic tool in several pathological clinical scenarios. With the progressive growth in technical expertise and dedicated devices, interventional endoscopic ultrasound procedures (IEUSP) have shown high rates of technical and clinical success, together with a relatively safe profile. However, the description and the standardization of different and specific types of adverse events (AEs) are still scarce in literature, and, consequently, even less the management of AEs. The aim of this study is to critical review and to describe AEs related to each of the main IEUSP, and to provide an overview on the possible management strategies of endoscopic complications. Future studies and guidelines are surely required to reach a better standardization of different AEs and their best management.