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Introduction: the presence of donor-specific antibodies (DSA) is thought to affect survival of the allograft and patient after liver transplantation (LT). However, their significance is not well understood. Patients and methods: a prospective study was performed of 32 adult patients who underwent LT in 2011 to analyze the existence of DSA, associated risk factors and medium-term impact. Immunological determinations were performed immediately before LT and at three, six, 12 months and five years after LT. Results: eight patients (24.2 %) presented pre-formed DSA. However, titers were negative in all patients five years after LT and there were no associated events. Eight out of 24 patients (33.3 %) developed de novo DSA. After five years, only two remained positive; both were class II with high mean fluorescence intensity (MFI) values at diagnosis (over 15,000). No association was found between the development of DSA and the risk of rejection, graft loss or death. However, an increase in liver stiffness values was observed in patients with persistent DSA, and focal sinusoidal deposition of C4d and moderate liver fibrosis were reported. Conclusion: the incidence of DSA is high after LT. In addition, the persistence of de novo DSA could be associated with silent liver fibrosis with a potential impact on graft outcomes.

Narrow band imaging (NBI) allows identification of abnormal areas of Barrett’s esophagus (BE) and could facilitate targeted biopsies. We evaluated the diagnostic accuracy for dysplasia prediction using non-magnifying NBI in Evis Exera III processors and high-definition endoscopes using the Barrett International NBI Group (BING) classification, as well as inter/intraobserver agreement for dysplasia prediction and mucosal/vascular patterns. Eight observers (4 staff endoscopists and 4 trainee endoscopists) evaluated 100 images selected from an anonymized bank of 470 photographs using the BING classification. Observers were to assign their individual assessment of the mucosal and vascular pattern, and prediction for dysplasia. Accuracy for dysplasia prediction and intra/interobserver agreement was calculated. Dysplasia prediction had an accuracy of 81.1%, sensitivity of 48.4%, and a specificity of 91%. Positive predictive value and negative predictive value (NPV) were 61.4 and 85.5%, respectively. Dysplasia prediction done with a high degree of confidence (vs. low degree of confidence) had better diagnostic accuracy (85.8 vs. 70.7%). Interobserver concordance for dysplasia was weak: Κ = 0.40. Agreement for mucosal and vascular patterns was 0.39 and 0.30, respectively. Intraobserver concordance (assessed 6 months after initial test) for mucosal pattern, vascular pattern, and dysplasia prediction was moderate: Κ = 0.56, Κ = 0.47 and Κ = 0.60, respectively. Our results showed that NBI had a significant accuracy in BE assessment for dysplasia prediction, high specificity (>90%), and NPV (>85%), with suboptimal sensitivity. NBI could be a useful additional tool for BE inspection and targeted biopsies, but cannot avoid the need for biopsies following the Seattle protocol.

We present the case of a 42-year-old female under study due to dyspepsia without response to empirical treatment, with perioral mucocutaneous pigmentation. A gastroscopy revealed a 5 cm gastric tumor in the antrum, as well as multiple sessile gastric and duodenal polyps smaller than 1 cm. Large-capacity forceps biopsies were obtained and a well-differentiated adenocarcinoma with gastric origin was diagnosed, with over expression of the HER2/neu without microsatellite instability in the context of a hamartomatous polyposis. The genomic study confirmed an alteration in the STK11 gene translated to a truncated protein product, compatible with a Peutz-Jeghers syndrome (PJS).

Background: post-sphyncterotomy endoscopic retrograde cholangiopancreatography (ERCP) bleeding is an adverse event with an estimated incidence rate of 1.34%. There is no established consensus about how to treat this particular type of gastrointestinal bleed. Placement of fully covered self-expandable biliary metal stents (FCSEBMS) has been evaluated as an alternative treatment with positive outcomes and a low complication rate. Aim: to report the results of a cohort of patients with post-sphyncterotomy bleeding treated in a tertiary care referral hospital with FCSEBMS. Methods: a retrospective cases series study was performed including all post-ERCP bleeds treated with FCSEBMS (immediate or delayed) from January 2015 to June 2017. Clinical data, laboratory results and endoscopic reports were collected in order to evaluate the rebleeding rate after endoscopic treatment. Two different scenarios were considered: a) prophylactic stent placement after effective endoscopic treatment; and b) stents placed for the treatment of an active postsphyncterotomy bleed, refractory to standard endoscopic therapy. Results: twenty-two patients (14 male, eight women) diagnosed with postsphyncterotomy bleeding were treated with FCSEBMS placement. The stents were placed prophylactically in 15 patients, while the stents were placed as a treatment for a refractory bleed in seven patients. No differences were found between both groups except for a higher anticoagulation rate in the treatment group. Clinical success was achieved in all but one patient, with no complications in relation to stent placement. Distal migration was described in two of the 22 patients included in the study. Conclusions: temporary placement of FCSEBMS seems to be a technically feasible treatment option for post-ERCP bleeding with a high clinical success rate. The complication rate was low, although randomized studies are needed.

Resumen Introduccion Los ensayos clinicos aleatorizados proporcionan la mejor evidencia cientifica de la eficacia de los farmacos biologicos en la enfermedad inflamatoria intestinal (EII). Sin embargo, los resultados pueden no ser reproducibles en la practica clinica. Los objetivos de este estudio son analizar el porcentaje de pacientes con EII tratados con farmacos biologicos que habrian podido ser elegidos para un ensayo clinico aleatorizado y comparar la eficacia teorica de los farmacos biologicos con su efectividad en la practica clinica. Metodos Realizamos un estudio retrospectivo multicentrico en 375 pacientes con EII tratados con anti-TNF con un seguimiento de un ano. Los criterios de elegibilidad para la condicion de ensayo clinico fueron extraidos de los estudios pivotales ACCENT, SONIC, ACT, CLASSIC y CHARM. Los pacientes elegibles fueron incluidos en un segundo analisis para comparar los resultados en la practica clinica con los obtenidos tras realizar una estimacion teorica si el paciente hubiese sido incluido en un estudio pivotal. Resultados Solo el 45,6% de los 375 pacientes cumplian los criterios de seleccion para un estudio pivotal. El beneficio clinico al ano fue similar entre los pacientes elegibles y no elegibles (68,4% vs 68,6%). El beneficio clinico en los pacientes elegibles fue mayor en la practica clinica que en la condicion hipotetica de un ensayo clinico (68,4% vs 44,4%, p Conclusion Mas de la mitad de los pacientes con EII tratados con farmacos biologicos no estarian representados en los ensayos pivotales. La efectividad de los farmacos anti-TNF en la practica clinica es superior a su eficacia teorica.

Background and aims: The aims of this study were to evaluate the frequency of entero-urinary fistulas in a cohort of Crohn’s disease (CD) patients and to analyse the outcomes of medical and surgical therapy. Methods: This multicentre retrospective study included all CD patients with entero-urinary fistulas diagnosed by the presence of clinical symptoms and confirmed at surgery or by radiological or endoscopic techniques. We evaluated outcomes of medical and surgical therapy. We defined remission as absence of clinical symptoms with a radiological confirmation of fistula closure. Cox regression analysis was performed to evaluate factors predictive of achieving remission without need for surgery. Results: Of 6081 CD patients screened, 97 had entero-urinary fistulas (frequency 1.6%). Seventy-five percent of fistulas occurred in men. After a median follow-up of 91 months, 96% of patients were in sustained remission. Thirty-three patients (35%) received anti-tumour necrosis factor (TNF) therapy. Of these, 45% achieved sustained remission (median follow-up 35 months) without needing surgery. More than 80% of patients required surgery, which induced remission (median follow-up 101 months) in 99% of them. Only the use of anti-TNF agents was associated with an increased rate of remission without need for surgery (hazard ratio 0.23, 95% confidence interval 0.12–0.44; p < 0.001). Conclusion: In this large cohort of CD patients, the frequency of entero-urinary fistulas was lower than previously described. More than 80% of patients required surgery, and in all but one of them surgery induced sustained remission. In a selected subgroup of patients, anti-TNF may induce long-term fistula remission and radiographic closure, making it possible to avoid surgery.

Background and Aims TC-325 (Hemospray, Cook Medical, Winston-Salem, NC) is an inorganic hemostatic powder recently approved by the U.S. Food and Drug Administration. This study aimed to examine the effectiveness, safety, and predictors of TC-325 failure in a large real-life cohort. Methods This was a retrospective study conducted at 21 Spanish centers. All patients treated with TC-325 until September 2018 were included. The primary outcome was treatment failure, defined as failed intraprocedural hemostasis or recurrent bleeding within the first 30 postprocedural days. Secondary outcomes included safety and survival. Risk and predictors of failure were assessed via competing-risk models. Results The cohort comprised 261 patients, of whom 219 (83.9%) presented with upper gastrointestinal bleeding (GIB). The most common causes were peptic ulcer (28%), malignancy (18.4%), and therapeutic endoscopy-related GIB (17.6%). TC-325 was used as rescue therapy in 191 (73.2%) patients. The rate of intraprocedural hemostasis was 93.5% (95% confidence interval [CI], 90%-96%). Risks of TC-325 failure at postprocedural days 3, 7, and 30 were 21.1%, 24.6%, and 27.4%, respectively. On multivariate analysis, spurting bleeding (P = .004), use of vasoactive drugs (P = .02), and hypotension (P = .008) were independent predictors of failure. Overall 30-day survival was 81.9% (95% CI, 76%-86%) and intraprocedural hemostasis was associated with a better prognosis (adjusted hazard ratio, 0.29; P = .006). Two severe adverse events were noted. Conclusion TC-325 was safe and effective for intraprocedural hemostasis in more than 90% of patients, regardless of the cause or site of bleeding and its use as rescue therapy. In this high-risk cohort treated with TC-325, the 30-day failure rate exceeded 25% and was highest with spurting bleeding or hemodynamic instability.

Introduction: Benign esophageal strictures are relatively frequent and can severely affect the quality of life of a patient. Stenting has been proposed for the treatment of refractory cases. Lesions affecting the cervical esophagus are more difficult to treat, and the placement of stents in this location has traditionally been restricted due to potential adverse events. The aim of this study was to describe the efficacy and safety of endoscopic stenting in the management of refractory benign cervical esophageal strictures (RBCES) in a single-center cohort study. Methods: We analyzed 12 patients with RBCES (Kochman’s criteria) and severe dysphagia. We recorded previous endoscopic treatments, stricture characteristics and demographic data. The two types of stents used were fully covered self-expandable metallic stents (FCSEMS) and uncovered biodegradable stents (BDS). FCSEMS were removed eight weeks after placement, and BDS were followed-up until degradation. We assessed technical and clinical success, rate of stricture recurrence and adverse events. Results: The mean age of participants was 64 years (range 30-85). A total of 23 stents (13 FCSEMS and 10 BDS) were placed in 12 patients (median 1.92, range 1-4). The technical success rate was 96% (22/23 stents). Eight patients (66.6%) maintained adequate oral intake at the end of follow-up (median 33.3 months, range 3-84 months). Migration was recorded in 7/23 stents (30.4%) and epithelial hyperplasia in 4/23 stents (17.4%). No severe adverse events were noted. All patients complained of minor cervical pain after placement that was well controlled with mild analgesia. Conclusions: Endoscopic stent therapy seems to be effective and safe in the management of RBCES.

Introduction Randomised controlled trials provide the best scientific evidence for the efficacy of biological drugs in inflammatory bowel disease (IBD). However, findings obtained from these trials might not be reproducible in clinical practice. This study aimed to estimate the percentage of patients with IBD treated with biologics who would have been eligible for randomised controlled trials, and to compare the theoretical efficacy of biological drugs with their effectiveness in clinical practice. Methods We performed a retrospective multicentre study in 375 patients with IBD treated with anti-TNF agents and followed-up for 1 year. The eligibility criteria for the trial were taken from the ACCENT, SONIC, ACT, CLASSIC and CHARM trials. Eligible patients were included in a second analysis to compare results in clinical practice versus those hypothetically obtained if the patient had been included in a trial. Results Only 45.6% of 375 patients would have been eligible for pivotal trials. One-year clinical benefit (remission or response) was similar for eligible and non-eligible cohorts (68.4% vs. 68.6%, p = 0.608). The clinical benefit was greater for current clinical practice than for a hypothetical trial situation (68.4% vs. 44.4%, p Conclusion More than half of patients with IBD treated with biologic drugs would not be represented in pivotal trials. The effectiveness of anti-TNF drugs in clinical practice exceeds their theoretical efficacy.