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BACKGROUND AND AIMS: Digital single-operator cholangioscopy (d-SOC) with cholangioscopic biopsy sampling has shown promise in the evaluation of indeterminate biliary strictures. Some studies have suggested higher sensitivity for visual impression compared with biopsy sampling, although assessors were not blinded to previous investigations. We aimed to investigate the diagnostic accuracy and interobserver agreement (IOA) of d-SOC in the visual appraisal of biliary strictures when blinded to additional information. METHODS: A multicenter, international cohort study was performed. Cholangioscopic videos in patients with a known final diagnosis were systematically scored. Pseudonymized videos were reviewed by 19 experts in 2 steps: blinded for patient history and investigations and unblinded. RESULTS: Forty-four high-quality videos were reviewed of 19 benign and 25 malignant strictures. The sensitivity and specificity for the diagnosis of malignancy was 74.2% and 46.9% (blinded) and 72.7% and 62.5% (unblinded). Cholangioscopic certainty of a malignant diagnosis led to overdiagnosis (sensitivity, 90.6%; specificity, 33%), especially if no additional information was provided. The IOA for the presence of malignancy was fair for both assessments (Fleiss' κ = .245 [blinded] and κ = .321 [unblended]). For individual visual features, the IOA ranged from slight to moderate for both assessments (κ = .059-.400 vs κ = .031-.452). CONCLUSIONS: This study showed low sensitivity and specificity for blinded and unblinded d-SOC video appraisal of indeterminate biliary strictures, with considerable interobserver variation. Although reaching a consensus on the optical features of biliary strictures remains important, optimizing visually directed biopsy sampling may be the most important role of cholangioscopy in biliary stricture assessment. ispartof: GASTROINTESTINAL ENDOSCOPY vol:94 issue:6 pages:1059-1068 ispartof: location:United States status: published

Main RecommendationsThe European Society of Gastrointestinal Endoscopy (ESGE) has recognized the need to formalize and enhance training in endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS). This manuscript represents the outcome of a formal Delphi process resulting in an official Position Statement of the ESGE and provides a framework to develop and maintain skills in ERCP and EUS. This curriculum is set out in terms of the prerequisites prior to training; recommended steps of training to a defined syllabus; the quality of training; and how competence should be defined and evidenced before independent practice. 1 Trainees should be competent in gastroscopy prior to commencing training. Formal training courses and the use of simulation in training are recommended. 2 Trainees should keep a contemporaneous logbook of their procedures, including key performance indicators and the degree of independence. Structured formative assessment is encouraged to enhance feedback. There should be a summative assessment process prior to commencing independent practice to ensure there is robust evidence of competence. This evidence should include a review of a trainee’s procedure volume and current performance measures. A period of mentoring is strongly recommended in the early stages of independent practice. 3 Specifically for ERCP, all trainees should be competent up to Schutz level 2 complexity (management of distal biliary strictures and stones > 10 mm), with advanced ERCP requiring a further period of training. Prior to independent practice, ESGE recommends that a trainee can evidence a procedure volume of > 300 cases, a native papilla cannulation rate of ≥ 80 % (90 % after a period of mentored independent practice), complete stones clearance of ≥ 85 %, and successful stenting of distal biliary strictures of ≥ 90 % (90 % and 95 % respectively after a mentored period of independent practice). 4 The progression of EUS training and competence attainment should start from diagnostic EUS and then proceed to basic therapeutic EUS, and finally to advanced therapeutic EUS. Before independent practice, ESGE recommends that a trainee can evidence a procedure volume of > 250 cases (75 fine-needle aspirations/biopsies [FNA/FNBs]), satisfactory visualization of key anatomical landmarks in ≥ 90 % of cases, and an FNA/FNB accuracy rate of ≥ 85 %. ESGE recognizes the often inadequate quality of the evidence and the need for further studies pertaining to training in advanced endoscopy, particularly in relation to therapeutic EUS.

Hemangiomas are benign vascular gastrointestinal tumours. They are infrequent, located in the submucosa, and can be asymptomatic or cause intestinal obstruction, anaemia or ferropenia. Their initial diagnosis is usually endoscopic despite the absence of pathognomonic features. Traditionally their treatment has been surgical although endoscopic resection is now possible. We present a case of ferropenia resolved after endoscopic resection of a capillary duodenal hemangioma.

Background and study aims The etiology of idiopathic acute pancreatitis (IAP) should always be defined. Our aim was to compare the diagnostic value of endoscopic ultrasound (EUS) versus secretin-enhanced magnetic resonance cholangiopancreatography (S-MRCP) in patients with IAP. Patients and Methods Patients admitted to a single tertiary care University hospital with IAP were invited to participate in the study. Enrolled patients underwent EUS and S-MRCP in a single-blinded comparative study. EUS and S-MRCP were performed no sooner than 4 weeks after discharge. The diagnostic yield of EUS and S-MRCP and demographic variables were included in the analysis. Additional follow-up, results of subsequent serology, radiographic exams, and relevant histological analysis were considered in determination of the final diagnosis. Results A total of 34 patients were enrolled; EUS was normal in six, cholelithiasis was defined in 15, choledocholithiasis in two, pancreas divisum in three, branch-type intraductal papillary mucinous tumor (IPMT) in three, and chronic pancreatitis in five. S-MRCP identified choledocholithiasis in one, divisum in four, branch-type IPMT in three, chronic pancreatitis in two; 24 subjects diagnosed as normal by S-MRCP. Diagnostic correlation between EUS and S-MRCP was slight (kappa = 0.236, 95 % confidence interval: 0.055–0.416). EUS provided a statistically significantly higher diagnostic yield than S-MRCP: 79.4 % (CI95 %: 65 %–94 %) vs 29.4 % (CI95 %: 13 %–46 %) (P = 0.0002). The sensitivity, specificity, and positive and negative predictive values of EUS and S-MRCP were 90 %, 80 %, 96 %, 57 % and 33 %, 100 %, 100 % and 16 %, respectively. Conclusion The diagnostic yield of EUS is higher than S-MRCP in patients with IAP.

Objective: despite significant progresses in imaging and pathological evaluation, early differentiation between benign and malignant biliary strictures remains challenging. Endoscopic retrograde cholangiopancreatography (ERCP) is used to investigate biliary strictures, enabling the collection of bile. We tested the diagnostic potential of next-generation sequencing (NGS) mutational analysis of bile cell-free DNA (cfDNA). Design: a prospective cohort of patients with suspicious biliary strictures (n=68) was studied. The performance of initial pathological diagnosis was compared with that of the mutational analysis of bile cfDNA collected at the time of first ERCP using an NGS panel open to clinical laboratory implementation, the Oncomine Pan-Cancer Cell-Free assay. Results: an initial pathological diagnosis classified these strictures as of benign (n=26), indeterminate (n=9) or malignant (n=33) origin. Sensitivity and specificity of this diagnosis were 60% and 100%, respectively, as on follow-up 14 of the 26 and eight of the nine initially benign or indeterminate strictures resulted malignant. Sensitivity and specificity for malignancy of our NGS assay, herein named Bilemut, were 96.4% and 69.2%, respectively. Importantly, one of the four Bilemut false positives developed pancreatic cancer after extended follow-up. Remarkably, the sensitivity for malignancy of Bilemut was 100% in patients with an initial diagnosis of benign or indeterminate strictures. Analysis of 30 paired bile and tissue samples also demonstrated the superior performance of Bilemut. Conclusion: implementation of Bilemut at the initial diagnostic stage for biliary strictures can significantly improve detection of malignancy, reduce delays in the clinical management of patients and assist in selecting patients for targeted therapies. Funding: we thank the financial support of CIBERehd; grants PI16/01126 and PI19/00163 from Instituto de Salud Carlos III (ISCIII) cofinanced by ’Fondo Europeo de Desarrollo Regional’ (FEDER) ’Una manera de hacer Europa’; grants 58/2017 and 55/2018 from Gobierno de Navarra Salud; grant 0011-1411-2020-000010 from AGATA Strategic Project from Gobierno de Navarra; grant 2020/101 from Euroregion Nouvelle Aquitaine-Euskadi-Navarra; Fundación Eugenio Rodríguez Pascual; Fundación Mario Losantos, Fundación M Torres; grant 2018/117 from AMMF, the Cholangiocarcinoma Charity; the COST Action CA181122 Euro-cholangio-Net; POSTD18014AREC postdoctoral fellowship from AECC to MA; and Ramón y Cajal Program contracts RYC-2014-15242 and RYC-2018-024475-1 to FJC and MGFB.

Background and Objectives: EUS-guided biliary drainage (EUS-BD) is increasingly utilized to manage unresectable malignant biliary obstruction after a failed ERCP. However, there is no data on how endoscopists perceive EUS-BD. The aim of this study was to investigate the perception of endoscopists on EUS-BD. Patients and Methods: A survey questionnaire of six topics with 22 survey statements was developed. A total of 17 pancreatobiliary endoscopists (10 from East and 7 from West) were invited to survey. The participants were asked to answer the multiple choice questionnaire and give comments. The opinions of the participants for individual survey statements were assessed using 5-point Likert scale. Results: All participants completed the survey. The endoscopists had a trend to perceive EUS-BD as a procedure indicated after a failed ERCP. Various EUS-BD methods were regarded as having different efficacy and safety. The superiority of EUS-BD over percutaneous transhepatic BD (PTBD) with regard to efficacy, procedure-related adverse events, and unscheduled re-intervention was not in agreement. Conclusions: EUS-BD was not yet perceived as the initial procedure to relieve the unresectable malignant biliary obstruction. Various EUS-BD methods were regarded as having different efficacy and safety. The superiority of EUS-BD over PTBD was not in agreement. Refining the procedure, developing dedicated devices, and gaining expertise in the procedure are necessary to popularize EUS-BD.

Background: Lumen apposing metal stent (LAMS) allows an easy access to peripancreatic fluid collections (PPFCs) and the possibility of performing direct endoscopic necrosectomy (DEN). The aim of our study was to evaluate the safety and efficacy of a new 20-mm LAMS in the management of PPFCs. This novel stent represents the largest diameter LAMS available on the market to date. Methods: This is an international, multicenter retrospective study involving 20 centers. Consecutive patients who underwent EUS-guided PPFC drainage using a 20-mm LAMS were included. Primary outcomes were technical and clinical success. Secondary outcomes were rate and the severity of adverse events. Results: A total 105 patients underwent PPFC drainage using the new 20-mm LAMS and 106 LAMS were placed. Technical success was 100% (106/106). 7/105 patients died due to causes not related to the stent. Clinical success was achieved in 92/98 patients (93.9%). Significant adverse events occurred in 8/98 patients (8.16%): 4 cases (4.08%) of bleeding, 3 cases (3.06%) of suprainfection, 1 case of gastric outlet obstruction. Conclusions: This multicenter study demonstrated acceptable rates of technical and clinical success using a new 20-mm LAMS for PPFC, including walled-off pancreatic necrosis (WOPN). The results of our study suggest that a new 20-mm LAMS is non-inferior in terms of safety, efficacy, and adverse events as compared to smaller diameter LAMS in the management of PPFCs, including pancreatic psuedocysts (PP) and WOPN. Randomized controlled studies will be needed to determine the ideal size of LAMS need to achieve the greatest clinical benefit with the minimized risk exposure for this high-risk patient population.

Aims To assess the efficacy of a protocol based on two different levels of protective equipment (PE) to avoid Covid 19(C19) infections in the endoscopy unit. Methods To resume our endoscopic activity after the first wave of C19 infection, a protection protocol depending on C19reverse transcription polymerase chain reaction (PCR) test result and clinical triage before endoscopy was established. Twoprotection levels were defined: Low (negative PCR and triage), requiring basic protection (hat, gloves, permeable coat, surgical mask in lower and fpp2 in upper endoscopy);and high (positive PCR or symptoms), requiring advanced protection(hat, ocular protection, fpp2 mask, gloves and waterpro of coat). Non urgent endoscopies where cancelled if PCR waspositive. A prospective research evaluating the efficacy of this protocol was completed from april 27th to june 24th. Patientswhere contacted 2 weeks later to exclude a possible C19 infection. Results 2304 patients, 46.1 % women, were included with mean age of 59.88 ±15,547. 987 gastroscopies, 1084colonoscopies, 113 ERCP, 101 ecoendoscopies, 9 enteroscopies and 173 rectosigmoidoscopies were performed. PreviousPCR was made to 2302 patients and was positive in 10 (7 endoscopies were cancelled). We classiffied 2291 (99.7 %)patients as low risk and 13 as high. The PE used by the endoscopist was considered appropriate in 42.2 %, excessive in 41 % and insufficient in 16.7 % according to the protection protocol. This was influenced by the endoscopist (p < 0,01) and thetype of endoscopy: in 43.1 % of the colonoscopies the PE was excessive (p < 0,001). None of the endoscopists were infectedby C19 during the research period. We contacted 1744 patients (75.9 %) with no suspicion of C19 in any. Conclusions A protocol based on two protection levels according to the risk of patients to be infected and the type ofendoscopic procedure, seems to be useful to avoid C19 infections in the endoscopy unit.

ERCP and EUS are complementary techniques in the management of biliary and pancreatic diseases. Combination of these two techniques can reach different levels of complexity with increasing rates of adverse events. In this article we propose a categorization of the relationship between EUS and ERCP based on whether EUS indicates, complements, facilitates or replaces ERCP. It has implications for the complexity of the technique, the training of the endoscopist and the necessary hospital resources. This classification can also be useful in planning endoscopist training and patient management.

Cholangiocarcinoma (CCA) and pancreatic adenocarcinoma (PDAC) may lead to the development of extrahepatic obstructive cholestasis. However, biliary stenoses can also be caused by benign conditions, and the identification of their etiology still remains a clinical challenge. We performed metabolomic and proteomic analyses of bile from patients with benign (n = 36) and malignant conditions, CCA (n = 36) or PDAC (n = 57), undergoing endoscopic retrograde cholangiopancreatography with the aim of characterizing bile composition in biliopancreatic disease and identifying biomarkers for the differential diagnosis of biliary strictures. Comprehensive analyses of lipids, bile acids and small molecules were carried out using mass spectrometry (MS) and nuclear magnetic resonance spectroscopy (1H-NMR) in all patients. MS analysis of bile proteome was performed in five patients per group. We implemented artificial intelligence tools for the selection of biomarkers and algorithms with predictive capacity. Our machine-learning pipeline included the generation of synthetic data with properties of real data, the selection of potential biomarkers (metabolites or proteins) and their analysis with neural networks (NN). Selected biomarkers were then validated with real data. We identified panels of lipids (n = 10) and proteins (n = 5) that when analyzed with NN algorithms discriminated between patients with and without cancer with an unprecedented accuracy., This research was funded by: Instituto de Salud Carlos III (ISCIII) co-financed by Fondo Europeo de Desarrollo Regional (FEDER) Una manera de hacer Europa, grant numbers: PI16/01126 (M.A.A.), PI19/00819 (M.J.M. and J.J.G.M.), PI15/01132, PI18/01075 and Miguel Servet Program CON14/00129 (J.M.B.); Fundación Científica de la Asociación Española Contra el Cáncer (AECC Scientific Foundation), grant name: Rare Cancers 2017 (J.M.U., M.L.M., J.M.B., M.J.M., R.I.R.M., M.G.F.-B., C.B., M.A.A.); Gobierno de Navarra Salud, grant number 58/17 (J.M.U., M.A.A.); La Caixa Foundation, grant name: HEPACARE (C.B., M.A.A.); AMMF The Cholangiocarcinoma Charity, UK, grant number: 2018/117 (F.J.C. and M.A.A.); PSC Partners US, PSC Supports UK, grant number 06119JB (J.M.B.); Horizon 2020 (H2020) ESCALON project, grant number H2020-SC1-BHC-2018–2020 (J.M.B.); BIOEF (Basque Foundation for Innovation and Health Research: EiTB Maratoia, grant numbers BIO15/CA/016/BD (J.M.B.) and BIO15/CA/011 (M.A.A.). Department of Health of the Basque Country, grant number 2017111010 (J.M.B.). La Caixa Foundation, grant number: LCF/PR/HP17/52190004 (M.L.M.), Mineco-Feder, grant number SAF2017-87301-R (M.L.M.), Fundación BBVA grant name: Ayudas a Equipos de Investigación Científica Umbrella 2018 (M.L.M.). MCIU, grant number: Severo Ochoa Excellence Accreditation SEV-2016-0644 (M.L.M.). Part of the equipment used in this work was co-funded by the Generalitat Valenciana and European Regional Development Fund (FEDER) funds (PO FEDER of Comunitat Valenciana 2014–2020). Gobierno de Navarra fellowship to L.C. (Leticia Colyn); AECC post-doctoral fellowship to M.A.; Ramón y Cajal Program contracts RYC-2014-15242 and RYC2018-024475-1 to F.J.C. and M.G.F.-B., respectively. The generous support from: Fundación Eugenio Rodríguez Pascual, Fundación Echébano, Fundación Mario Losantos, Fundación M Torres and Mr. Eduardo Avila are acknowledged. The CNB-CSIC Proteomics Unit belongs to ProteoRed, PRB3-ISCIII, supported by grant PT17/0019/0001 (F.J.C.). Comunidad de Madrid Grant B2017/BMD-3817 (F.J.C.).

The diagnostic workup and endoscopic therapeutic management of periampullary biliary strictures is influenced by two factors: presence of a periampullary tumor and jaundice. In jaundiced tumoral patients, a single endoscopic session including EUS with FNA first followed by ERCP with drainage of the biliary tract should be done. In these patients, the endoscopic drainage can be a bridging therapy to surgery or definitive before palliative treatment. In non-jaundiced tumoral patients ERCP can be obviated and managed surgically or with palliative measures after FNA with confirmation of malignancy. In patients with benign strictures endoscopic therapy by means of sphincterotomy and/or placement of a stent must be considered in jaundiced or symptomatic patients. In these patients, EUS plays a key role ruling out the presence of malignant lesions. When ERCP fails to achieve biliary drainage in any of these patients, EUS-guided access to the biliary tract must be considered in centers with expertise in these fields.

El tratamiento endoscopico de las complicaciones locales de la pancreatitis cronica ha ganado terreno en los ultimos anos frente a la alternativa quirurgica. La menor agresividad del tratamiento endoscopico frente al quirurgico, asi como la posibilidad de ser aplicado repetidas veces en pacientes de alto riesgo, han favorecido este desarrollo. Ademas, la incorporacion de nuevas opciones terapeuticas endoscopicas altamente resolutivas, como la litotricia guiada por pancreatoscopia y los tratamientos guiados por ecoendoscopia, hace que el tratamiento endoscopico sea de primera eleccion en muchos casos, a pesar de disponer de datos discordantes en la literatura. En este articulo se hace una revision del tratamiento endoscopico de las complicaciones locales mas frecuentes de la pancreatitis cronica, como la pancreatolitiasis, los pseudoquistes y la estenosis ductal pancreatica, biliar y duodenal

Background and Objectives: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) and fine needle biopsy (FNB) are effective techniques that are widely used for tissue acquisition. However, it remains unclear how to obtain high-quality specimens. Therefore, we conducted a survey of EUS-FNA and FNB techniques to determine practice patterns worldwide and to develop strong recommendations based on the experience of experts in the field. Methods: This was a worldwide multi-institutional survey among members of the International Society of EUS Task Force (ISEUS-TF). The survey was administered by E-mail through the SurveyMonkey website. In some cases, percentage agreement with some statements was calculated; in others, the options with the greatest numbers of responses were summarized. Another questionnaire about the level of recommendation was designed to assess the respondents' answers. Results: ISEUS-TF members developed a questionnaire containing 17 questions that was sent to 53 experts. Thirty-five experts completed the survey within the specified period. Among them, 40% and 54.3% performed 50–200 and more than 200 EUS sampling procedures annually, respectively. Some practice patterns regarding FNA/FNB were recommended. Conclusion: This is the first worldwide survey of EUS-FNA and FNB practice patterns. The results showed wide variations in practice patterns. Randomized studies are urgently needed to establish the best approach for optimizing the FNA/FNB procedures.

Background It seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON). To date, there is no quality of evidence to recommend LAMS as the standard treatment in the management of WON. The theoretical benefit of LAMS over plastic stents needs to be proven. Methods/design This is a randomized controlled, multicenter, prospective clinical trial with two parallel groups, without masking. One-hundred and fourteen patients with WON will undergo endoscopic ultrasound (EUS)-guided transmural draining in nine tertiary hospitals in Spain and will be randomized to the LAMS or plastic-stent group. The primary endpoint is the short-term (4 weeks) clinical success determined by the reduction of the collection (to Discussion The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON. Trial registration ClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home

BACKGROUND AND OBJETIVES Due to the potential risks associated with stent placement, European Society Gastrointestinal Endoscopy does not recommend prophylactic insertion of stents in patients without symptoms. The aim was to compare complication rates, need of surgery, colostomy formation, and survival between stent placement prior to start of chemotherapy (SEMS group) and upfront ChT (ChT group) in patients with endoscopically non-transverable metastatic left-sided colorectal cancer. METHODS Gender, age, CEA, tumor location, sites of metastatic disease, peritoneal involvement, liver involvement, and angiogenesis inhibitors administration, were recorded. Complication rates, need of surgery, stoma creation, and survival were compared between both groups by univariate and multivariate test. Complications of SEMS placement in both groups were compared. RESULTS We studied 75 men and 40 women, with a mean age of 66.3 years. Overall complication and perforation rates were similar but patients in the ChT group had a significant higher need of surgery and subsequent stoma creation. Perforation after SEMS placement rates were higher in patients receiving ChT than in patients without ChT. Survival was related to peritoneal carcinomatosis and administration of biological agents. CONCLUSIONS SEMS placement prior to ChT administration dismissed the need of subsequent surgery and decreased the rates of permanent stoma formation.

Objectives Previous studies have shown changes in the pancreas of type 1 diabetic (T1-DM) patients, similar to those present in patients with chronic pancreatitis. Our aim was to analyze the prevalence of endoscopic ultrasound (EUS) criteria for chronic pancreatitis in T1-DM, to determine the association with factors related to the diabetes and to define its clinical significance. Methods Eighty-six T1-DM patients were prospectively included. All of them underwent EUS. Standard criteria were used. Patients were divided into 3 groups according to the number of EUS criteria they met: group A, 0 to 2 criteria; group B, 3 to 4; and group C, more than 4. Association between EUS findings and demographic or clinical factors was studied as well as the relationship between EUS abnormalities and the presence of gastrointestinal symptoms or nutritional deficiencies. Results Fifty-three patients (61.6%) showed at least 1 morphologic abnormality. Fifty-eight patients were included in group A, 21 in group B, and 7 in Group C. No significant differences were found when comparing the 3 groups. Conclusions Chronic pancreatitis-like changes are frequent in the pancreas of T1-DM patients. These changes are not associated with demographic or clinical data. Therefore, the clinical relevance seems to be scarce.

New parameters complementary to clinical TNM classification are needed, to orient preoperative on the possibility of a R0 gastric cancer resection. We analysed the possible predictive value of blood neutrophil/lymphocytic ratio (N/L) in relation to resectability.Two hundred and fifty-seven gastric cancers consecutively diagnosed and without neoadjuvant treatment were retrospectively studied. Univariate and multivariate analysis of the frequency of R0 cases was performed between groups with a normal N/L ratio (5) and pathological N/L ratio (≥5). Furthermore, we studied the subgroup of operated patients (n=156) analysing the frequency of R0 resection according to N/L ratio5 or≥5.One hundred and fifty-six patients underwent surgical intervention, of which 139 had R0 resections. A high N/L ratio was registered in 46 cases (17.9%). Globally, resectability was higher in patients with a N/L ratio5: 59.7% vs. N/L ratio≥5: 28.6% (P.001; OR=3.76; 95% CI=1.78-8.04). The relation between N/L ratio5 and R0 resection was confirmed in the multivariate (P=.006; OR=3.86; 95% CI=1.46-10.22). In the operated subgroup, the higher frequency of R0 resection achievement is maintained in cases with N/L ratio5: 91.3% vs. 72.2% (P=.015; OR=4.04; 95% CI=1.23-13.26).The presence of a N/L ratio5 at the diagnosis of a gastric carcinoma is related in a significant and independent way with a higher frequency of R0 tumoral resection, globally. This higher proportion of R0 resection cases in patients with a N/L5 ratio is confirmed in the subgroup of operated patients.

Background and study aims Interventional endoscopic treatments including the application of glue are becoming more frequently used for the treatment of esophageal fistulas. However, there are no prospective studies of endoscopic treatment for esophageal fistulas. This prospective study aims to investigate the efficacy and safety of endoscopic injection of alpha-cyanoacrylate monomer for intractable esophageal fistulas. Patients and methods This single-center prospective phase II trial included patients with more than 1 wk of conservative medical treatment for intractable esophageal fistulas after esophagectomy. In the image-guided therapy suite, a mixture of alpha-cyanoacrylate monomer and oily contrast agent in a ratio of 0.3 to 1.7 mL was endoscopically injected through the fistula. Results Twenty-five patients who underwent esophagectomy at Wakayama Medical University Hospital were enrolled in this study. The primary disease was esophageal cancer in 16 patients (64 %) and gastric cancer in the remaining 9 patients (36 %). Complete closure of the esophageal fistula was performed in 22 patients after endoscopic injection of alpha-cyanoacrylate monomer. The overall success rate was 88 %. There was no fistula recurrence in any successful closure cases. Three patients with failed esophageal fistula closure had esophageal cancer with cervical esophageal fistulas and required reoperation of the fistulectomy under general anesthesia. No complications associated with this endoscopic treatment were detected. Conclusions Endoscopic treatment with injection of alpha-cyanoacrylate monomer facilitated healing of post-esophagectomy fistula in 88 % of patients without complications. This suggests that the treatment is effective and safe for patients with esophageal fistulas.

Fundamento: El Índice Pronóstico nutricional (IPN) combina los valores de los linfocitos circulantes y la albúmina sérica y, en la literatura asiática, se le ha relacionado con el pronóstico tras la resección R0 del cáncer gástrico, sin disponer de resultados en países occidentales. Estudiamos, en el momento del diagnóstico del tumor, el posible valor pronóstico independiente del IPN, sobre la supervivencia. Pacientes y Métodos: Revisamos 234 carcinomas gástricos consecutivos, determinando la supervivencia global y la específica por el tumor. Consideramos patológicos los valores del IPN pre-tratamiento < 40. Realizamos un análisis univariante y multivariante de las supervivencias según el IPN, incluyendo las siguientes variables de ajuste: edad > 70 años, ASA anestésico al diagnóstico, tamaño de la neoplasia > 5 cm, tipo macroscópico infiltrante, grado indiferenciado y estadificación clínica TNM mediante ecoendoscopia y/o TAC. Resultados: El análisis univariante registró una mayor supervivencia global y específica en los casos con IPN ≥ 40 versus IPN < 40: [HR = 2,28; IC 95% = (1,60-3,26); p< 0,001] y [HR = 2,35; IC 95% = (1,63-3,39); p< 0,001], respectivamente. El análisis multivariante confirmó un mejor pronóstico independiente en los casos con IO ≥ 40: supervivencia global: [HR = 1,48; IC 95% = (1,02-2,16); p = 0,040], supervivencia específica: [HR = 1,51; IC 95% = (1,03-2,23); p = 0,036]. Conclusiones: En el momento del diagnóstico del cáncer gástrico e incluyendo la totalidad de los casos registrados, un IPN ≥ 40 se acompaña de una supervivencia global y específica por el tumor significativamente mayor. En nuestra serie, este mejor pronóstico es independiente del grupo de edad del paciente, de su clasificación ASA, del tamaño y grado de diferenciación de la neoplasia y de su estadificación clínica TNM. Background: The Prognostic Nutritional Index (PNI) combines the values of circulating lymphocytes and serum albumin and, in the Asian literature; it has been related with the prognosis following R0 resection of gastric cancer. No results are available in Western countries. We study the possible independent prognostic value, at the moment of the tumour's diagnosis, of PNI on survival. Patients and methods: We review 234 consecutive gastric carcinomas, calculating global survival and tumour-specific survival. We considered pre-treatment PNI values of < 40 to be pathological. We carried out a univariate and multivariate analysis of cases of survival according to PNI, including the following adjustment variables: age > 70 years, ASA anaesthetic at the time of diagnosis, size of the neoplasia > 5cm, macroscopic type, undifferentiated degree and TNM clinical stage through echoendoscopy and/or CAT. Results: The univariate analysis registered greater global and specific survival in cases with PNI ≥ 40 versus PNI < 40: [HR = 2.28; CI 95% = (1.60-3.26); p< 0.001] and [HR = 2.35; CI 95% = (1.63-3.39); p< 0.001], respectively. The multivariate analysis confirmed a better independent prognosis in cases with OI ≥ 40: global survival: [HR = 1.48; CI 95% = (1.02-2.16); p = 0.040], specific survival: [HR = 1.51; CI 95% = (1.03-2.23); p = 0.036]. Conclusions: At the moment of diagnosis of gastric cancer and including all registered cases, a PNI ≥ 40 is accompanied by a significantly greater global and tumour-specific survival. In our series, this better prognosis is independent of the patient's age group, his/her ASA classification, the size and degree of differentiation of the neoplasia and its TNM clinical stage.

Resumen Introduccion Publicaciones recientes han reactivado la discusion sobre el valor pronostico de la elevacion pretratamiento del antigeno carcinoembrionario (CEA) en el cancer colorrectal. Debido a los resultados discordantes comunicados, pretendemos analizar en nuestro medio esta posible capacidad predictiva, globalmente y en los diferentes estadios tumorales. Pacientes y metodos Estudiamos retrospectivamente 303 canceres colorrectales resecados consecutivamente con intencion curativa, analizando la mortalidad debida al tumor. Determinamos la frecuencia de casos con CEA pretratamiento patologico (>5 mg/l). Comparamos mediante analisis univariante y multivariante las curvas de supervivencia entre los casos con CEA normal y patologico, tanto en el global de la serie como en los diferentes estadios pTNM. Resultados La frecuencia de pacientes con CEA > 5 mg/l fue del 31%. La mediana de seguimiento clinico alcanzo los 83 meses. En el analisis multivariante de la serie global, la supervivencia fue desfavorable para los casos con CEA elevado: hazard ratio (HR) = 1,89; intervalo de confianza al 95% (IC 95%) = (1,15-3,10); p = 0,012. Al efectuar el analisis de supervivencia en los diversos estadios, unicamente se mantiene el valor predictivo en el estadio II (n = 104): HR = 3,02; IC 95% = (1,22-7,45); p = 0,017. Conclusiones Antes del inicio del tratamiento, un 31% de nuestros canceres colorrectales resecados con intencion curativa presentaron unos valores patologicos de CEA. Considerando la serie globalmente, la elevacion del CEA pretratamiento presenta, de modo independiente, un valor pronostico desfavorable sobre la supervivencia, pero al analizar su valor predictivo segun los diferentes estadios, solo mantiene su significacion en el estadio pTNM II.

BACKGROUND AND OBJECTIVE: The management of branch-duct intraductal papillary mucinous neoplasms (BD-IPMNs) is determined by a number of guidelines. The current weight of risk factors by EUS predicting invasive cancer is unknown. The aim of this study is to develop a risk score for early prediction of invasive cancer according to morphological characterization by EUS in a surgical cohort. MATERIALS AND METHODS: This is an observational, multicenter retrospective study. All consecutive patients with a histologically proven BD-IPMN who underwent previous EUS between 2005 and 2017 were included. Morphological features by EUS were evaluated. A score using a logistic regression model was performed to assess the risk of invasive cancer. RESULTS: Of 335 patients who underwent pancreatic surgery, 131 (median age: 66 years, 50.4% - male) were included. By multivariable analysis, lymph nodes (odds ratio [OR]: 17.7 [confidence interval (CI) 95%: 2.8-112.6], P = 0.002, 4 points), main pancreatic duct ≥10 mm (OR: 8.6 [CI 95%: 1.9-39.5], P = 0.006, 2 points), abrupt change of pancreatic duct (OR: 5.5 [CI 95%: 1.4-22.2], P = 0.016, 1.5 points), and solid component (OR: 4.2 [CI 95%: 1.3-13.6], P = 0.017, 1 point) were independent factors associated with invasive cancer and included in the model. The following categories of the score (0-8.5 points) - A (0-1), B (1.5-3), C (3.5-5), and D (5.5-8.5 points) - presented a positive predictive value of 8.5%, 38.9%, 62.5%, and 100%, respectively. The area under the curve was 0.857 (P < 0.001), with an overall sensitivity and specificity of 84% and 70% in the internal validation of the score. CONCLUSION: This EUS predictive score for invasive cancer in BD-IPMN has a high accuracy and could be an additional tool to consider in patient management.

Introduction: the incidence of cystic pancreatic lesions (CPL) in the asymptomatic population is increasing. Achieving a preoperative diagnosis of CPL still remains a challenge. Objectives: to evaluate the diagnostic accuracy of the cytological diagnosis of CPL from samples obtained by cytology brush versus standard endoscopic ultrasound fine needle aspiration (EUS-FNA). Methods: a multicenter, randomized, open-label trial was performed of EUS-cytology brush (EUS-EB) versus EUS-FNA for the cytological diagnosis of CPL. Patients that underwent EUS-FNA with a CPL > 15 mm were included and randomized into two groups: group I, EUS-EB; group II, EUS-FNA. The final diagnosis was based on the histological evaluation of surgical specimens and clinical parameters, imaging and a five year follow-up in non-operated patients. The main outcome was the diagnostic accuracy of both methods. Secondary outcomes were the diagnostic adequacy of specimens and the rate of adverse events. Data were compared using the Chi-squared test. An intention to treat (ITT) and per-protocol (PP) analysis were performed. Results: sixty-five patients were included in the study, 31 in group I and 34 in group II. Three patients initially randomized to group I were changed to group II as it was impossible to obtain a sample using the brush. The mean size of the CPL was 28.2 mm (range 16-60 mm). The diagnostic accuracy of EUS-EB was not superior to EUS-FNA, neither in the ITT nor the PP analysis (44.8% vs 41.1%, p = 0.77 and 38.4% vs 45.9%, p = 0.55). Conclusions: EUS-EB does not improve the diagnostic accuracy of CPL in comparison with EUS-FNA.

OBJECTIVES: The objective of guideline was to provide clear and relevant consensus statements to form a practical guideline for clinicians on the indications, optimal technique, safety and efficacy of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN).METHODS: Six important clinical questions were determined regarding EUS-CPN. Following a detailed literature review, 6 statements were proposed attempting to answer those questions. A group of expert endosonographers convened in Chicago, United States (May 2016), where the statements were presented and feedback provided. Subsequently a consensus group of 35 expert endosonographers voted based on their individual level of agreement. A strong recommendation required 80% voter agreement. The modified GRADE (Grading of Recommendations Assessment, Development, and Evaluation) criteria were used to rate the strength of recommendations and the quality of evidence.RESULTS: Eighty percent agreement was reached on 5 of 6 consensus statements, 79.4% agreement was reached on the remaining one.CONCLUSIONS: EUS-CPN is efficacious, should be integrated into the management of pancreas cancer pain, and can be considered early at the time of diagnosis of inoperable disease. Techniques may still vary based on operator experience. Serious complications exist, but are rare.

Introduction Peroral endoscopic myotomy (POEM) has been performed since 2008 on more than 5,000 patients. It has proven to be highly effective in the treatment of achalasia and has shown promising outcomes for other esophageal motility spastic disorders. Methods A literature review of the efficacy of POEM compared to the previous invasive treatments for different esophageal motility disorders was performed. The application in the pediatric and elderly populations and its role as a rescue therapy after other procedures are also outlined. Results Short-term outcomes are similar to laparoscopic Heller myotomy (LHM) and pneumatic endoscopic dilation (PD) (clinical success > 90%) for achalasia subtypes I and II. Mid-term outcomes are comparable to LHM and overcome the results obtained after PD (> 90% vs ~50%). With regard to type III achalasia, POEM efficacy is 98% compared to 80.8% for LHM and the PD success remains at 40%. With regard to spastic esophageal disorders (SED), POEM has an effectiveness of 88% and 70% for distal esophageal spasm (DES) and jackhammer esophagus (JE) respectively. A response of 95% in patients with sigmoid esophagus has been reported. POEM has been performed in pediatric and elderly populations and has obtained a higher efficacy than PD in pediatric series (100% vs 33%) without greater adverse events. Previous treatments do not seem to hinder POEM results with excellent response rates, including 97% in post LHM and 100% in a re-POEM series. Final considerations: POEM has shown excellent short and mid-term results for all subtypes of achalasia but long-term results are not yet available. The promising results in SED may make POEM the first-line treatment for SED. A high-safety profile and efficacy have been shown in elderly and pediatric populations. Previous treatments do not seem to diminish the success rate of POEM. Core tip: POEM has emerged as an efficient treatment option for all subtypes of achalasia and other scenarios (including previous treatments and elderly and pediatric populations). Short and mid-term results are comparable to LHM and are better than PD data. The clinical response rate of DES and JE may make POEM the first-line treatment for SED.

Hepatocellular carcinoma rarely invades the biliary tree. Clots or tumor embolus passing though the bile duct can cause pancreatitis by a mechanism similar to gallstone pancreatitis. We present the case of a patient with recurrent acute pancreatitis, initially suspicious of biliary origin. Despite cholecystectomy he had new episodes of acute pancreatitis. Hepatocellular carcinoma was diagnosed after the third episode. ERCP findings suggested the presence of a fistula connecting the tumor and the biliary tree. The patient was operated and the hepatocellular carcinoma was resected. Its pathological analysis confirmed the communication between the tumor and the biliary duct.

Los inmunosupresores se encuentran entre los grupos farmacológicos con mayor potencial teórico de inducir reacciones adversas, entre ellas las hepáticas. Presentamos el caso de un paciente de 35 años con enfermedad de Crohn en tratamiento con azatioprina por corticodependencia al que se le diagnosticó tras realización de una biopsia hepática de hiperplasia nodular regenerativa secundaria a este tratamiento.

Background EUS-guided cholangiopancreatography (ESCP) allows transmural access to biliopancreatic ducts when ERCP fails. Data regarding technical details, safety, and outcomes of ESCP are still unknown. Objective To evaluate outcomes of ESCP in community and referral centers at the initial development phase of this procedure, to identify the ESCP stages with higher risk of failure, and to evaluate the influence on outcomes of factors related to the endoscopist. Design Multicenter retrospective study. Setting Public health system hospitals with experience in ESCP in Spain. Patients A total of 125 patients underwent ESCP in 19 hospitals, with an experience of Intervention ESCP. Main Outcome Measurements Technical success and complication rates in the initial phase of implantation of ESCP are described. The influence of technical characteristics and endoscopist features on outcomes was analyzed. Results A total of 125 patients from 19 hospitals were included. Biliary ESCP was performed in 106 patients and pancreatic ESCP was performed in 19. Technical success was achieved in 84 patients (67.2%) followed by clinical success in 79 (63.2%). Complications occurred in 29 patients (23.2%). Unsuccessful manipulation of the guidewire was responsible for 68.2% of technical failures, and 58.6% of complications were related to problems with the transmural fistula. Limitations Retrospective study. Conclusion Outcomes of ESCP during its implantation stage reached a technical success rate of 67.2%, with a complication rate of 23.2%. Intraductal manipulation of the guidewire seems to be the most difficult stage of the procedure.

Cholecystocolic fistula is an uncommon biliary-enteric fistula with a variable clinical presentation that usually appears as a rare complication of gallstone disease. It can present with abdominal pain, nausea, weight loss, diarrea with or without associated steatorrhea, and dyspeptic symptoms. Rare cases have been reported with lower gastrointestinal hemorrage and even with a gallstone illeous. The most useful techniques for diagnosis are CT, barium studies, and ERCP. Although a diagnosis of cholecystocolic fistula is rarely suspected clinically, it should be considered in elderly patients with unexplained pneumobilia or unexplained persistent diarrhea. The standard treatment for these fistulas is cholecystectomy and excision of the fistula. Endoscopic sphincterotomy is an option in the treatment of elderly unfit patients as it can cause spontaneous healing of the fistula by reducing increased biliary pressure. Also, spontaneous resolution of the fistula has been described, although it is not very common. We report a case of a cholecistocolic fistula in an eldery woman with multiple medical comorbidities that presented as a lower gastrointestinal bleeding. She was explored with colonoscopy, abdominal CT and barium enema. She required a total of 4 units of whole blood and because of her comorbidities a decision was made not to proceed with invasive treatment. She had a good evolution and was asintomatic two months later.

Introduccion: La pancreaticogastrostomia (PG) y pancreaticoduodenostomia (PD) guiadas por ecoendoscopia permiten el drenaje transparietal del conducto pancreatico cuando no es posible por via transpapilar. Objetivo: evaluar resultados tecnicos y clinicos obtenidos con la PG/PD en nuestro medio. Identificar variantes tecnicas asociadas al exito tecnico y clinico. Metodo: Analisis retrospectivo incluyendo la experiencia en PG/PD de 6 anos en 5 hospitales terciarios. Variables: epidemiologicas, indicacion, evolucion clinica posterior, complicaciones precoces (primer mes) y tardias (tras el primer mes). En el seguimiento distinguimos un grupo al que se hizo recambio programado de las protesis (Grupo A), y otro con recambio segun clinica (Grupo B). Resultados: 27 PG/PD (edad media: 53,6 anos). La indicacion fue: estenosis (23); desconexion ductal (3), fistula pancreaticocutanea (1). El 92% presentaban dolor de semiologia pancreatica. Exito tecnico en 85% realizando 20 PG y 3 PD. Complicaciones precoces (15%): dolor (2), pancreatitis (1) y coleccion (1). Complicaciones tardias (19%): obstruccion de protesis (1), pancreatolitiasis (1), migracion de protesis (2), neumatosis cistoide (1). Hubo complicaciones tardias en 100% de PD vs. 10% de PG. Exito clinico en 95% de pacientes con exito tecnico, resolviendose el dolor en el 95%. Seguimiento medio: 21,8 meses. El 39% de los pacientes pertenecian al Grupo A, en todos se hizo recambio programado de la protesis mientras el 14% del Grupo B lo requirio (p 0,05), ni evolucion clinica (Exito clinico: 89%vs100%, p > 0,05) entre ambos grupos. Conclusiones: El exito tecnico de la PG/PD ecoendoscopica alcanza el 85% con exito clinico del 95%, destacando una excelente respuesta del dolor. Nuestros datos orientan a que no es necesario programar recambios de las protesis y a un mayor indice de complicaciones en relacion a la PD.

The presence of subdiaphragmatic thyroid tissue is a very rare finding. We reviewed the literature and found only 15 published cases. The most appropriate management of this entity has not been established, but surgical removal is common to exclude malignancy. We present the case of a 76-year-old woman with an ectopic mesenteric thyroid gland forming a retroperitoneal mass that was surgically removed. Outcome was favorable.

Background and Objectives: EUS-guided biliary drainage (EUS-BD) was shown to be useful for malignant biliary obstruction (MBO). However, there is lack of consensus on how EUS-BD should be performed. Methods: This was a worldwide multi-institutional survey among members of the International Society of EUS conducted in February 2018. The survey consisted of 10 questions related to the practice of EUS-BD. Results: Forty-six endoscopists of them completed the survey. The majority of endoscopists felt that EUS-BD could replace percutaneous transhepatic biliary drainage after failure of ERCP. Among all EUS-BD methods, the rendezvous stenting technique should be the First choice. Self-expandable metal stents (SEMSs) were recommended by most endoscopists. For EUS-guided hepaticogastrostomy (HGS), superiority of partially-covered SEMS over fully-covered SEMS was not in agreement. 6-Fr cystotomes were recommended for fistula creation. During the HGS approach, longer SEMS (8 or 10 cm) was recommended. During the choledochoduodenostomy approach, 6-cm SEMS was recommended. During the intrahepatic (IH) approach, the IH segment 3 was recommended. Conclusion: This is the first worldwide survey on the practice of EUS-BD for MBO. There were wide variations in practice, and randomized studies are urgently needed to establish the best approach for the management of this condition.