Prospective multicenter study to identify optimal target population for motorized spiral enteroscopy.

Motorized spiral enteroscopy (MSE) enhances small bowel exploration, but the optimal target population for this technique is unknown. We aimed to identify the target population for MSE by evaluating its efficacy and safety, as well as detecting predictors of efficacy. A prospective multicenter observational study was conducted at 9 tertiary hospitals in Spain, enrolling patients between June 2020-2022. Analyzed data included demographics, indications for the procedure, exploration time, depth of maximum insertion (DMI), technical success, diagnostic yield, interventional yield, and adverse events (AE) up to 14 days from enteroscopy. Patients with prior gastrointestinal surgery, unsuccessful balloon enteroscopy and small bowel strictures were analyzed. A total of 326 enteroscopies (66.6% oral route) were performed in 294 patients (55.1% males, 65 years ± 21). Prior abdominal surgery was present in 50% of procedures (13.5% gastrointestinal surgery). Lower DMI (162 vs 275 cm, p = 0.037) and diagnostic yield (47.7 vs 67.5%, p = 0.016) were observed in patients with prior gastrointestinal surgery. MSE showed 92.2% technical success and 56.9% diagnostic yield after unsuccessful balloon enteroscopy (n = 51). In suspected small bowel strictures (n = 49), the finding was confirmed in 23 procedures (46.9%). The total AE rate was 10.7% (1.8% classified as major events) with no differences related to prior gastrointestinal/abdominal surgery, unsuccessful enteroscopy, or suspected small bowel strictures. The study demonstrates that MSE has a lower diagnostic yield and DMI in patients with prior gastrointestinal surgery but is feasible after unsuccessful balloon-enteroscopy and in suspected small bowel strictures without safety concerns.

Environmental footprint and material composition comparison of single-use and reusable duodenoscopes.

BACKGROUND: Infection outbreaks associated with contaminated reusable duodenoscopes (RUDs) have induced the development of novel single-use duodenoscopes (SUDs). This study aimed to analyze the material composition and life cycle assessment (LCA) of RUDs and SUDs to assess the sustainability of global and partial SUD implementation. METHODS: A single-center study evaluated material composition analysis and LCA of one RUD and two SUDs from different manufacturers (A/B). Material composition analysis was performed to evaluate the thermochemical properties of the duodenoscope components. The carbon footprint was calculated using environmental software. We compared the sustainability strategies of universal use of RUDs, frequent use of RUDs with occasional SUDs, and universal use of SUDs over the lifetime of one RUD. RESULTS: RUDs were substantially heavier (3489 g) than both SUD-A (943 g) and SUD-B (716 g). RUDs were mainly metal alloys (95%), whereas SUDs were mainly plastic polymers and resins (70%-81%). The LCA demonstrated the sustainability of RUDs, with a life cycle carbon footprint 62-82 times lower than universal use of SUDs (152 vs. 10 512-12 640 kg CO2eq) and 10 times lower than occasional use of SUDs (152 vs. 1417-1677 kg CO2eq). Differences were observed between SUD-A and SUD-B (7.9 vs. 6.6 kg CO2eq per endoscope). End-of-life incineration emissions for SUDs were the greatest environmental contributors. CONCLUSIONS: Widespread adoption of SUDs has greater environmental challenges; it requires a balance between infection control and environmental responsibility. Carbon footprint labelling can help healthcare institutions make sustainable choices and promote environmentally responsible healthcare practices.

Life cycle assessment of routinely used endoscopic instruments and simple intervention to reduce our environmental impact.

OBJECTIVES: GI endoscopy units represent the third largest producers of medical waste. We aimed to determine endoscopic instrument composition and life cycle assessment (LCA) and to assess a sustainability proposal based on a mark on the instruments that identifies parts can be safely recycled or 'green mark'. DESIGN: Material composition analysis and LCA of forceps, snares and clips from four different manufacturers (A-D) were performed with four different methods. Carbon footprint from production, transportation and end of life of these instruments was calculated. In 30 consecutive procedures, we marked the contact point with the working channel. 5 cm away from that point was considered as green mark. One-week prospective study was conducted with 184 procedures evaluating 143 instruments (75 forceps, 49 snares and 19 haemoclips) to assess the efficacy of this recyclable mark. RESULTS: Composition from different manufacturers varied widely. Most common materials were high global warming potential (GWP) waste (polyethylene, polypropylene and acrylonitrile) and low GWP waste (stainless steel). Significant differences were found for the forceps (0.31-0.47 kg of CO2 equivalent (CO2-eq)) and haemoclips (0.41-0.57 kg CO2-eq) between the manufacturers. Green mark was established 131.26 cm for gastroscope and 195.32 cm for colonoscope. One-week activity produced 67.74 kg CO2-eq. Applying our sustainability intervention, we could reduce up to 27.44% (18.26 kg CO2-eq). This allows the recycling of 61.7% of the instrument total weight (4.69 kg). CONCLUSION: Knowledge of carbon footprint is crucial to select the most sustainable alternatives because there are large variations between brands. A mark to identify recyclable parts could reduce our environmental impact significantly.

Documento de consenso de la Sociedad Española de Endoscopia Digestiva sobre SpyGlass-DS / SEED Consensus Document on SpyGlass-DS

La colangiopancreatografía retrógrada endoscópica (CPRE) es la técnica de elección para el tratamiento de la patología biliopancreática. Sin embargo, las imágenes fluoroscópicas no siempre permiten un diagnóstico adecuado. Por otra parte, algunos cálculos de gran tamaño no se pueden extraer con los métodos habituales. En estas situaciones, la colangioscopia ha mostrado ser una herramienta fundamental para el diagnóstico de las estenosis biliares y el tratamiento de los cálculos de gran tamaño. Además, su papel en la patología pancreática está en creciente aumento. El desarrollo de un colangioscopio de un único operador y desechable ha permitido expandir la técnica entre buena parte de los hospitales que realizan CPRE. Por este motivo, la Sociedad Española de Endoscopia Digestiva ha desarrollado este documento de consenso sobre la utilización del colangioscopio Spyglass-DS. El documento ha sido elaborado por un grupo de endoscopistas expertos en colangioscopia, revisando la evidencia científica de las principales indicaciones actuales de la colangiopancreatoscopia.(AU)

Endoscopic retrograde cholangiopancreatography (ERCP) is the technique of choice for the treatment of biliopancreatic pathology. However, fluoroscopic imaging does not always allow an adequate diagnosis. On the other hand, some large stones cannot be removed by the usual methods. In these situations, cholangioscopy has proven to be an essential tool for the diagnosis of biliary strictures and the treatment of large stones. Its role in pancreatic pathology is also increasing. The development of a single-operator, disposable cholangioscope has made it possible to expand the technique to a large number of hospitals that perform ERCP. For this reason, the Spanish Society of Digestive Endoscopy has developed this consensus document on the use of the Spyglass-DS cholangioscope. The document has been prepared by a group of endoscopists with expertise in cholangioscopy, reviewing the scientific evidence on the main current indications for cholangiopancreatoscopy.(AU)

SEED Consensus Document on SpyGlass-DS. / Documento de consenso de la Sociedad Española de Endoscopia Digestiva sobre SpyGlass-DS.

Endoscopic retrograde cholangiopancreatography (ERCP) is the technique of choice for the treatment of biliopancreatic pathology. However, fluoroscopic imaging does not always allow an adequate diagnosis. On the other hand, some large stones cannot be removed by the usual methods. In these situations, cholangioscopy has proven to be an essential tool for the diagnosis of biliary strictures and the treatment of large stones. Its role in pancreatic pathology is also increasing. The development of a single-operator, disposable cholangioscope has made it possible to expand the technique to a large number of hospitals that perform ERCP. For this reason, the Spanish Society of Digestive Endoscopy has developed this consensus document on the use of the Spyglass-DS cholangioscope. The document has been prepared by a group of endoscopists with expertise in cholangioscopy, reviewing the scientific evidence on the main current indications for cholangiopancreatoscopy.

Impact of the European Society of Gastrointestinal Endoscopy 2020 guidelines on the number of scheduled post-polypectomy surveillance colonoscopies: Meeting presentations: Partial results of this research were published in abstract form at ESGE Days 2020.

Background and study aims In contrast with the European Society of Gastrointestinal Endoscopy (ESGE) 2013 and the US Multi-society Task Force (USMSTF) 2020 guidelines, the ESGE 2020 guideline considers patients with three to four adenomas < 10 mm or an adenoma with villous histology as low risk. The aim of this study was to quantify the influence of the application of the new ESGE 2020 guidelines, as opposed to the ESGE 2013 and USMSTF 2020 guidelines, on the number of scheduled colonoscopies, and to describe the main causes for changes in the surveillance intervals. Patients and methods A retrospective evaluation was conducted of a prospectively maintained fecal immunochemical test (FIT)-based regional colorectal cancer screening program database. Surveillance regimens following ESGE 2020, ESGE 2013, and USMSTF 2020 guidelines were compared. Results Overall, 1284 individuals with a positive FIT and undergoing colonoscopy were consecutively included. When applying the ESGE 2020 guidelines, 10.8 % of patients changed to a "no-surveillance" group (relative reduction in colonoscopies of 82.5 %). The main reason for these changes was considering three to four adenomas as low risk. The proportion of patients from the "3-year surveillance" group who moved to the "no-surveillance" group was lower when a sessile serrated lesion (SSL) was present (ESGE 2013, 32.0% vs 16.3 %; USMSTF 2020 17.2 % vs 6.8 %). Analyzing the 41 patients with SSLs who remained unchanged in the "no-surveillance" group, only in 15 (36.6 %) the cause was the presence of an SSL. Conclusions applying the new ESGE 2020 guidelines could reduce by 11 % the proportion of individuals being offered surveillance. SLLs have not a major influence on the change of surveillance intervals.

Classification Predictive Model for Air Leak Detection in Endoworm Enteroscopy System.

Current enteroscopy techniques present complications that are intended to be improved with the development of a new semi-automatic device called Endoworm. It consists of two different types of inflatable cavities. For its correct operation, it is essential to detect in real time if the inflatable cavities are malfunctioning (presence of air leakage). Two classification predictive models were obtained, one for each cavity typology, which must discern between the "Right" or "Leak" states. The cavity pressure signals were digitally processed, from which a set of features were extracted and selected. The predictive models were obtained from the features, and a prior classification of the signals between the two possible states was used as input to different supervised machine learning algorithms. The accuracy obtained from the classification predictive model for cavities of the balloon-type was 99.62%, while that of the bellows-type was 100%, representing an encouraging result. Once the models are validated with data generated in animal model tests and subsequently in exploratory clinical tests, their incorporation in the software device will ensure patient safety during small bowel exploration.

Development of knowledge-based clinical decision support system for patients included in colorectal screening program / Desarrollo de un sistema de soporte a la decisión médica basado en el conocimiento para los pacientes incluidos en el programa de cribado del cáncer colorrectal

Background & aims: Colorectal (CRC) screening programs represent a large volume of procedures that need a follow-up endoscopy. A knowledge-based clinical decision support system (K-CDSS) is a technology which contains clinical rules and associations of compiled data that assist with clinical decision-making tasks. We develop a K-CDSS for management of patients included in CRC screening and surveillance of colorectal polyps. Methods: We collected information on 48 variables from hospital colonoscopy records. Using DILEMMA Solutions Platform © (https://www.dilemasolution.com) we designed a prototype K-CDSS (PoliCare CDSS), to provide tailored recommendations by combining patients data and current guidelines recommendations. The accuracy of rules was verified using four scenarios (normal colonoscopy, lesions different than polyps, non-advanced adenomas and advanced adenomas). We studied the degree of agreement between the clinical assessments made by expert doctors and nurses equipped with PoliCare CDSS. Two experts confirmed a correlation between guidelines and PoliCare recommendations. Results: 56 consecutive endoscopy cases from colorectal screening program were included (62.8 years; range 53-71). Colonoscopy results were: absence of colon lesions (n=7, 12.5%), lesions in the colon that are not polyps (n=3, 5.4%) and resected colonic polyps (n=46, 82.1%; 100% R0 resection). Patients with resected polyps presented non-advanced adenoma (n=21, 45.6%) or advanced lesions (n=25, 54.4%). There were no differences in erroneous orders with PoliCare CDSS (Kappa value 1.0). Conclusions: PoliCare CDSS can easily be integrated into the workflow for improving the overall efficiency and better adherence to evidence-based guidelines.(AU)

Antecedentes & objetivos: Los programas de cribado de cáncer colorrectal (CCR) generan un gran número de colonoscopias de seguimiento. Un sistema de soporte a la decisión clínica basado en el conocimiento (K-CDSS) es una tecnología que contiene reglas clínicas y asociaciones de datos que ayudan en la tarea de toma de decisiones clínicas. El objetivo fue desarrollar un K-CDSS para el manejo de los pacientes de cribado de CCR, y evaluar su eficacia. Métodos: Recolectamos información de 48 variables de registros de colonoscopia. Mediante el software DILEMMA (https://www.dilemasolution.com) diseñamos un prototipo de K-CDSS (PoliCare CDSS), para proporcionar recomendaciones personalizadas, combinando los datos de los pacientes y las recomendaciones de las guías actuales. La exactitud de las reglas se verificó mediante cuatro escenarios (colonoscopia normal, lesiones diferentes a pólipos, adenomas no avanzados y adenomas avanzados). Se estudió el grado de concordancia entre las valoraciones clínicas realizadas por médicos expertos y enfermeros equipados con PoliCare CDSS. Dos expertos confirmaron una correlación entre las pautas y las recomendaciones de PoliCare. Resultados: Se incluyeron 56 casos consecutivos del programa de cribado (62,8 años; rango 53-71). Los resultados de la colonoscopia fueron: ausencia de lesiones de colon (n = 7, 12,5%), lesiones en el colon que no son pólipos (n = 3, 5,4%) y pólipos de colon resecados (n = 46, 82,1%; resección R0 del 100%). Los pacientes con pólipos resecados presentaron adenoma no avanzado (n = 21, 45,6%) o lesiones avanzadas (n = 25, 54,4%). No hubo diferencias en recomendaciones erróneas con PoliCare CDSS (valor Kappa 1.0). Conclusiones: PoliCare CDSS se puede integrar fácilmente en el flujo de trabajo de una unidad de endoscopia digestiva.(AU)

Development of knowledge-based clinical decision support system for patients included in colorectal screening program.

BACKGROUND & AIMS: Colorectal (CRC) screening programs represent a large volume of procedures that need a follow-up endoscopy. A knowledge-based clinical decision support system (K-CDSS) is a technology which contains clinical rules and associations of compiled data that assist with clinical decision-making tasks. We develop a K-CDSS for management of patients included in CRC screening and surveillance of colorectal polyps. METHODS: We collected information on 48 variables from hospital colonoscopy records. Using DILEMMA Solutions Platform © (https://www.dilemasolution.com) we designed a prototype K-CDSS (PoliCare CDSS), to provide tailored recommendations by combining patients data and current guidelines recommendations. The accuracy of rules was verified using four scenarios (normal colonoscopy, lesions different than polyps, non-advanced adenomas and advanced adenomas). We studied the degree of agreement between the clinical assessments made by expert doctors and nurses equipped with PoliCare CDSS. Two experts confirmed a correlation between guidelines and PoliCare recommendations. RESULTS: 56 consecutive endoscopy cases from colorectal screening program were included (62.8 years; range 53-71). Colonoscopy results were: absence of colon lesions (n=7, 12.5%), lesions in the colon that are not polyps (n=3, 5.4%) and resected colonic polyps (n=46, 82.1%; 100% R0 resection). Patients with resected polyps presented non-advanced adenoma (n=21, 45.6%) or advanced lesions (n=25, 54.4%). There were no differences in erroneous orders with PoliCare CDSS (Kappa value 1.0). CONCLUSIONS: PoliCare CDSS can easily be integrated into the workflow for improving the overall efficiency and better adherence to evidence-based guidelines.

Prevention of late complications with coverage agents in endoscopic resection of colorectal lesions: Current landscape in gastrointestinal endoscopy.

Endoscopic removal of large (≥ 20 mm) non-pedunculated colorectal lesions (LNPCLs) may result in major adverse events, such as delayed bleeding (DB) and delayed perforation (DP), despite closure of the mucosal defects with clips. Topical application of a coverage agent refers to the creation of a shield with a biocompatible medical device (tissue or hydrogel) with proven bioactive properties. Coverage of the eschar after endoscopic resection provides shielding protection to prevent delayed complications. The aim of the present review was to systematically collect and review the currently available literature regarding the prevention of DB and DP with coverage agents after endoscopic mucosal resection or endoscopic submucosal dissection of LNPCLs.

Evaluation of the optical criteria for sessile serrated lesions of the colon: A prospective study on a colorectal cancer screening population.

Background and study aims We aimed to describe the presence and combination of Hazewinkel's optical diagnosis (OD) criteria for sessile serrated lesions (SSL), determining which lesion characteristics increase the probability of a correct OD, with a focus on diminutive lesions. Patients and methods This was a prospective study describing the presence of Hazewinkel's OD criteria for SSL in lesions found in consecutive CRC screening colonoscopies. The presence of each OD criterion and their diagnostic combinations in SSL, related to the lesion's NBI International Colorectal Endoscopic (NICE) classification category, size, and location, were described. The presence of two or more optical criteria was considered diagnostic of SSL. The OD was compared to pathology as the gold standard. Results Seventy-nine SSLs (5.6 %) were diagnosed. Cloud-like appearance was the most prevalent OD criterion (35, 44.3 %). OD criteria were more frequently identified in NICE type 1, ≥ 10 mm, and proximal lesions. Only 26 SLLs fulfilled the OD criteria (sensitivity 32.9 %, 95 % CI 29.1 %-36.7 %). The sensitivity for diminutive SSL was 14.7 %, (95 % CI 11.9 %-17.6 %). Eighty-five lesions were optically diagnosed as SSL. However, only in 26 SSL was this the definitive diagnosis (positive predictive value 30.6 %, 95 % CI 26.9 %-34.3 %). Size > 5 mm and proximal location increased the probability of a correct diagnosis. The overall accuracy of the optical criteria was 92.0 % (95 % CI, 89.8 %-94.2 %). Conclusions The Hazewinkel's optical criteria are not reliable for a positive diagnosis of SSL, particularly for diminutive lesions.

Oral ingestion versus endoscopic delivery of endoscopic capsule in patients with previous gastrointestinal surgery (ORENCES study): A Spanish multicentre observational study.

BACKGROUND: Small Bowel Capsule Endoscopy is the first-choice technique for investigating the majority of small bowel diseases. Its most common complications are related to incomplete examinations and capsule retention. There is no consensus on how patients with previous gastrointestinal surgery should receive the capsule. OBJECTIVE: The primary endpoint was to compare the rate of complete small-bowel examinations (completion rate) between oral ingestion and endoscopic delivery of the capsule. The secondary endpoint was to compare diagnostic yield and adverse events in the two groups. METHODS: A retrospective observational study was conducted in nine hospitals in Spain. Demographic data, previous surgery, indication for capsule endoscopy, intestinal transit time, diagnosis, completion rate (percentage of capsules reaching the caecum), diagnostic yield (percentage of results compatible with indication for the exam) and adverse events were collected. RESULTS: From January 2009 to May 2019 fifty-seven patients were included (39 male, mean age 66±15 years). The most common indications for the exam were "overt" (50.9%) and "occult" (35.1%) small bowel bleeding. Previous Billroth II gastrectomy and Roux-en-Y gastric bypass were present in 52.6% and 17.5% of patients respectively. The capsule was swallowed in 34 patients and placed endoscopically in 23 patients. No significant differences were observed between the oral ingestion and endoscopic delivery groups in terms of completion rate (82.4% vs. 78.3%; p=0.742), diagnostic yield (41.2% vs. 52.2%; p=0.432) or small bowel transit time (301 vs. 377min, p=0.118). No capsule retention occurred. Only one severe adverse event (anastomotic perforation) was observed in the endoscopic delivery group. CONCLUSIONS: In our case series, there were no significant differences between oral ingestion and endoscopic delivery in terms of completion rate, diagnostic yield or safety. Being less invasive, oral ingestion of the capsule should be the first-choice method in patients with previous gastrointestinal surgery.

CHOLANGIOPANCREATOSCOPY. WORKING PROTOCOL. SEED Recommendations.

Direct endoscopic visualization of biliary and pancreatic ducts represents one step further in the journey of digestive endoscopy. It allows the identification of lesions that were previously attainable through indirect means. Directed biopsy taking has permitted a better characterization of the lesions. The use of power sources through the cholangiopancreatoscope means that it is now possible to fragment and remove refractory lithiases using traditional endoscopic systems. This document aims to define the advisable workflow when using a single-use, flexible cholangiopancreatoscope with the commercial name of SpyGlass®. Penning a set of guidelines to provide instructions on the technique, as well as tips and tricks related with the operation of these endoscopes will be a useful resource.

Automatic evaluation of degree of cleanliness in capsule endoscopy based on a novel CNN architecture.

Capsule endoscopy (CE) is a widely used, minimally invasive alternative to traditional endoscopy that allows visualisation of the entire small intestine. Patient preparation can help to obtain a cleaner intestine and thus better visibility in the resulting videos. However, studies on the most effective preparation method are conflicting due to the absence of objective, automatic cleanliness evaluation methods. In this work, we aim to provide such a method capable of presenting results on an intuitive scale, with a relatively light-weight novel convolutional neural network architecture at its core. We trained our model using 5-fold cross-validation on an extensive data set of over 50,000 image patches, collected from 35 different CE procedures, and compared it with state-of-the-art classification methods. From the patch classification results, we developed a method to automatically estimate pixel-level probabilities and deduce cleanliness evaluation scores through automatically learnt thresholds. We then validated our method in a clinical setting on 30 newly collected CE videos, comparing the resulting scores to those independently assigned by human specialists. We obtained the highest classification accuracy for the proposed method (95.23%), with significantly lower average prediction times than for the second-best method. In the validation of our method, we found acceptable agreement with two human specialists compared to interhuman agreement, showing its validity as an objective evaluation method.