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Background and Objectives: Biliary drainage (BD) in patients with surgically altered anatomy (SAA) could be obtained endoscopically with different techniques or with a percutaneous approach. Every endoscopic technique could be challenging and not clearly superior over another. The aim of this survey is to explore which is the standard BD approach in patients with SAA. Materials and Methods: A 34-question online survey was sent to different Italian tertiary and non-tertiary endoscopic centers performing interventional biliopancreatic endoscopy. The core of the survey was focused on the first-line and alternative BD approaches to SAA patients with benign or malignant obstruction. Results: Out of 70 centers, 39 answered the survey (response rate: 56%). Only 48.7% of them declared themselves to be reference centers for endoscopic BD in SAA. The total number of procedures performed per year is usually low, especially in non-tertiary centers; however, they have a low tendency to refer to more experienced centers. In the case of Billroth-II reconstruction, the majority of centers declared that they use a duodenoscope or forward-viewing scope in both benign and malignant diseases as a first approach. However, in the case of failure, the BD approach becomes extremely heterogeneous among centers without any technique prevailing over the others. Interestingly, in the case of Roux-en-Y, a significant proportion of centers declared that they choose the percutaneous approach in both benign (35.1%) and malignant obstruction (32.4%) as a first option. In the case of a previous failed attempt at BD in Roux-en-Y, the subsequent most used approach is the EUS-guided intervention in both benign and malignant indications. Conclusions: This survey shows that the endoscopic BD approach is extremely heterogeneous, especially in patients with Roux-en-Y reconstruction or after ERCP failure in Billroth-II reconstruction. Percutaneous BD is still taken into account by a significant proportion of centers in the case of Roux-en-Y anatomy. The total number of endoscopic BD procedures performed in non-tertiary centers is usually low, but this result does not correspond to an adequate rate of referral to more experienced centers.
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Colangiopancreatografia Retrógrada Endoscópica , Drenaje , Humanos , Colangiopancreatografia Retrógrada Endoscópica/métodos , Drenaje/métodos , ItaliaRESUMEN
Background and Objectives: Serum alpha-fetoprotein (AFP) is a recognized affordable oncological marker in patients with hepatocellular carcinoma (HCC). However, AFP's prognostic role has been assessed mainly after specific treatments, and no unanimously recognized cut-offs have been identified. The aim of this study is to investigate the prognostic role of different basal AFP cut-offs on survival and HCC course. Materials and Methods: In this single-center, retrospective study, all patients newly diagnosed with HCC between January 2009 and December 2021 were prospectively enrolled. Only patients suitable for curative HCC treatments were included in the analyses. Patients were stratified according to AFP cut-offs of 20, 200, 400, and 1000 ng/mL, which were correlated with survival outcomes and clinical parameters. Results: A total of 266 patients were analyzed, with a median follow-up time of 41.5 months. Median overall survival (OS) of all cohort was 43 months. At the multivariate Cox-regression analysis, AFP value ≥ 1000 ng/mL correlated with impaired OS (1-year OS: 67% vs. 88%, 5-year OS: 1% vs. 43%; p = 0.005); other risk factors were tumor dimension ≥ 5 cm (HR 1.73; p = 0.002), Child-Pugh class B-C (HR 1.72; p = 0.002), BCLC stage A (vs. 0) (HR 2.4; p = 0.011), and malignant portal vein thrombosis (HR 2.57; p = 0.007). AFP ≥ 1000 ng/mL was also associated with a reduced recurrence-free survival (HR 2.0; p = 0.038), while starting from AFP ≥ 20 ng/mL, a correlation with development of HCC metastases over time (HR 3.5; p = 0.002) was seen. AFP values ≥ 20 ng/mL significantly correlated with tumor size and higher histological grading; starting from AFP values ≥ 400 ng/mL, a significant correlation with Child-Pugh class B-C and female gender was also observed. Conclusions: Basal AFP correlates with relevant outcomes in patients with HCC. It could help identify patients at a higher risk of worse prognosis who might benefit from personalized surveillance and treatment programs. Prospective studies are needed to confirm these results.
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Carcinoma Hepatocelular , Neoplasias Hepáticas , alfa-Fetoproteínas , Humanos , Carcinoma Hepatocelular/sangre , alfa-Fetoproteínas/análisis , Neoplasias Hepáticas/sangre , Masculino , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Pronóstico , Anciano , Biomarcadores de Tumor/sangre , Adulto , Modelos de Riesgos Proporcionales , Análisis de SupervivenciaRESUMEN
Background: Obesity is a chronic disease that impairs quality of life and leads to several comorbidities. When conservative therapies fail, bariatric surgical options such as Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are the most effective therapies to induce persistent weight loss. Over the last two decades, bariatric endoscopy has become a valid alternative to surgery in specific settings. Primary bariatric endoscopic therapies: Restrictive gastric procedures, such as intragastric balloons (IGBs) and endoscopic gastroplasty, have been shown to be effective in inducing weight loss compared to diet modifications alone. Endoscopic gastroplasty is usually superior to IGBs in maintaining weight loss in the long-term period, whereas IGBs have an established role as a bridge-to-surgery approach in severely obese patients. IGBs in a minority of patients could be poorly tolerated and require early removal. More recently, novel endoscopic systems have been developed with the combined purpose of inducing weight loss and improving metabolic conditions. Duodenal mucosal resurfacing demonstrated efficacy in this field in its early trials: significant reduction from baseline of HbA1c values and a modest reduction of body weight were observed. Other endoscopic malabsorptive have been developed but need more evidence. For example, a pivotal trial on duodenojejunal bypasses was stopped due to the high rate of severe adverse events (hepatic abscesses). Optimization of these more recent malabsorptive endoscopic procedures could expand the plethora of bariatric patients that could be treated with the intention of improving their metabolic conditions. Revisional bariatric therapies: Weight regain may occur in up to one third of patients after bariatric surgery. Different endoscopic procedures are currently performed after both RYGB and SG in order to modulate post-surgical anatomy. The application of argon plasma coagulation associated with endoscopic full-thickness suturing systems (APC-TORe) and Re-EndoSleeve have shown to be the most effective endoscopic treatments after RYGB and SG, respectively. Both procedures are usually well tolerated and have a very low risk of stricture. However, APC-TORe may sometimes require more than one session to obtain adequate final results. The aim of this review is to explore all the currently available primary and revisional endoscopic bariatric therapies focusing on their efficacy and safety and their potential application in clinical practice.
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Derivación Gástrica , Enfermedades Metabólicas , Obesidad Mórbida , Humanos , Obesidad Mórbida/cirugía , Calidad de Vida , Reoperación/métodos , Endoscopía/métodos , Derivación Gástrica/efectos adversos , Derivación Gástrica/métodos , Obesidad/cirugía , Obesidad/etiología , Resultado del Tratamiento , Pérdida de Peso , Estudios RetrospectivosRESUMEN
Safety of regorafenib in hepatocellular carcinoma (HCC) recurrence after liver transplantation (LT) has been recently demonstrated. We aimed to assess the survival benefit of regorafenib compared with best supportive care (BSC) in LT patients after sorafenib discontinuation. This observational multicenter retrospective study included LT patients with HCC recurrence who discontinued first-line sorafenib. Group 1 comprised regorafenib-treated patients, whereas the control group was selected among patients treated with BSC due to unavailability of second-line options at the time of sorafenib discontinuation and who were sorafenib-tolerant progressors (group 2). Primary endpoint was overall survival (OS) of group 1 compared with group 2. Secondary endpoints were safety and OS of sequential treatment with sorafenib + regorafenib/BSC. Among 132 LT patients who discontinued sorafenib included in the study, 81 were sorafenib tolerant: 36 received regorafenib (group 1) and 45 (group 2) received BSC. Overall, 24 (67%) patients died in group 1 and 40 (89%) in group 2: the median OS was significantly longer in group 1 than in group 2 (13.1 versus 5.5 months; P < 0.01). Regorafenib treatment was an independent predictor of reduced mortality (hazard ratio, 0.37; 95% confidence interval [CI], 0.16-0.89; P = 0.02). Median treatment duration with regorafenib was 7.0 (95% CI, 5.5-8.5) months; regorafenib dose was reduced in 22 (61%) patients for adverse events and discontinued for tumor progression in 93% (n = 28). The median OS calculated from sorafenib start was 28.8 months (95% CI, 17.6-40.1) in group 1 versus 15.3 months (95% CI, 8.8-21.7) in group 2 (P < 0.01). Regorafenib is an effective second-line treatment after sorafenib in patients with HCC recurrence after LT.
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Antineoplásicos , Carcinoma Hepatocelular , Neoplasias Hepáticas , Trasplante de Hígado , Antineoplásicos/efectos adversos , Carcinoma Hepatocelular/tratamiento farmacológico , Carcinoma Hepatocelular/cirugía , Humanos , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Hepáticas/cirugía , Trasplante de Hígado/efectos adversos , Compuestos de Fenilurea/efectos adversos , Piridinas , Estudios Retrospectivos , Sorafenib/uso terapéuticoRESUMEN
BACKGROUND AND AIM: Since the outbreak of COVID-19, concerns have been raised as to whether inflammatory bowel disease (IBD) patients under biologic therapy may be more susceptible to the disease. This study aimed to determine the incidence and outcomes of COVID-19 in a large cohort of IBD patients on biologic therapy. METHODS: This observational retrospective multicenter study collected data about COVID-19 in IBD patients on biologic therapy in Italy, between February and May 2020. The main end-points were (i) to assess both the cumulative incidence and clinical outcome of COVID-19, according to different biologic agents and (ii) to compare them with the general population and a cohort IBD patients undergoing non-biologic therapies. RESULTS: Among 1816 IBD patients, the cumulative incidence of COVID-19 was 3.9 per 1000 (7/1816) with a 57% hospitalization rate and a 29% case-fatality rate. The class of biologic agents was the only risk factor of developing COVID-19 (P = 0.01). Non-gut selective agents were associated with a lower incidence of COVID-19 cases, related symptoms, and hospitalization (P < 0.05). Compared with the general population of Lombardy, an overall lower incidence of COVID-19 was observed (3.9 vs 8.5 per 1000, P = 0.03). Compared with 565 IBD patients on non-biologic therapies, a lower rate of COVID-19 symptoms was observed in our cohort (7.5% vs 18%, P < 0.001). CONCLUSIONS: Compared with the general population, IBD patients on biologic therapy are not exposed to a higher risk of COVID-19. Non-gut selective agents are associated with a lower incidence of symptomatic disease, supporting the decision of maintaining the ongoing treatment.
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Factores Biológicos/administración & dosificación , Terapia Biológica/efectos adversos , COVID-19/epidemiología , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Adolescente , Adulto , Anciano , Niño , Preescolar , Colitis , Femenino , Humanos , Incidencia , Lactante , Recién Nacido , Enfermedades Inflamatorias del Intestino/epidemiología , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , SARS-CoV-2 , Adulto JovenRESUMEN
PURPOSE: To evaluate the treatment-induced toxicity (as primary endpoint) and the efficacy (as secondary endpoint) of stereotactic body radiation therapy (SBRT) in the treatment of mediastinal lymph nodes (LNs) in the so-called no-fly zone (NFZ) in cancers with various histology. MATERIAL AND METHODS: Forty-two patients were retrospectively analyzed. Institutional dose/volume constraints for organs at risk (OARs) derived by published data were strictly respected. The correlation between treatment-related variables and toxicity was investigated by logistic regression, Chi-squared test or Fisher's exact test. Overall survival (OS), cause-specific survival (CSS), progression-free survival (PFS) and local control (LC) were collected from the follow-up reports. The impact of potential predictive factors on LC, PFS and OS were estimated by Cox proportional-hazard regression. RESULTS: Median follow-up time was 16 months (range 1-41). Four patients had esophageal G1 toxicity. Ten and six patients had G1 and G2 pulmonary toxicity, respectively. Treatment site and irradiation technique were significantly correlated with G ≥ 2 and G ≥ 1 toxicity, respectively. OS probability at 19 months was 88.3% and corresponded to CSS. LC probability at 16 months was 66.3% (median LC duration: 22 months, range 1-41). Fifteen patients (35.7%) were disease-free at 25 months (median time, range 1-41). The biologically effective dose (BED) and the target dose coverage indexes were significantly correlated with LC. CONCLUSIONS: SBRT can be considered as a safe treatment option for selected patients with oligo-metastases/recurrences in the NFZ, if strict dose/volume constraints are applied.
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Metástasis Linfática/radioterapia , Neoplasias/patología , Traumatismos por Radiación/etiología , Radiocirugia/efectos adversos , Radiocirugia/métodos , Adulto , Anciano , Anciano de 80 o más Años , Supervivencia sin Enfermedad , Enfermedades del Esófago/etiología , Estudios de Factibilidad , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/mortalidad , Estudios Retrospectivos , Resultado del TratamientoAsunto(s)
Betacoronavirus , Colitis Ulcerosa/complicaciones , Infecciones por Coronavirus/complicaciones , Neumonía Viral/complicaciones , Anciano de 80 o más Años , Antiinflamatorios no Esteroideos/uso terapéutico , Antivirales/uso terapéutico , COVID-19 , Prueba de COVID-19 , Técnicas de Laboratorio Clínico , Colitis Ulcerosa/tratamiento farmacológico , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/tratamiento farmacológico , Resultado Fatal , Femenino , Humanos , Mesalamina/uso terapéutico , Pandemias , Neumonía Viral/diagnóstico , Neumonía Viral/tratamiento farmacológico , SARS-CoV-2 , Tratamiento Farmacológico de COVID-19RESUMEN
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.
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Endosonografía , Ultrasonografía Intervencional , Humanos , Endosonografía/efectos adversos , Endosonografía/instrumentación , Endosonografía/normas , Endosonografía/métodos , Ultrasonografía Intervencional/efectos adversosRESUMEN
Patients presenting with acute colonic obstruction are usually evaluated in the emergency department and multiple specialties are involved in the patients' management. Pre-treatment evaluation is essential in order to establish the correct endoscopic indication for stent implantation. Contrast-enhanced imaging could allow the exclusion of benign causes of colonic obstruction and evaluation of the length of malignant stricture. Endoscopic stenting is the gold standard of treatment for palliative indications whereas there are still concerns about its use as a bridge to surgery. Different meta-analyses showed that stenting as a bridge to surgery improves short-term surgical outcomes but has no role in improving long-term outcomes. Multidisciplinary evaluation is also essential in patients that may be started on or are currently receiving antiangiogenic agents because endoscopic stenting may increase the risk of perforation. Evidence in the literature is weak and based on retrospective data. Here we report on how to correctly evaluate a patient with acute colonic malignant obstruction in collaboration with other essential specialists including a radiologist, surgeon and oncologist, and how to optimize the technique of endoscopic stenting.
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BACKGROUND: Several randomized clinical trials comparing different bowel preparations (BP) have shown similar efficacy; however, there is a lack of real-world studies on this topic. AIMS: This study aims to identify the most effective BP regimen in a real-world setting and any predictors of inadequate BP. METHODS: A retrospective single-center study was conducted over 14 months at an academic hospital including outpatient colonoscopies in which adult patients did not teach on how to perform BP before colonoscopy. Colonoscopies with 1L-PEG, 2L-PEG and picosulphate mixtures were considered. A multivariable analysis for factors associated to poor BP was fitted. RESULTS: Overall, 1779 patients (51 %F, 60±14) years were included. The 1L-PEG regimen provided a higher rate of BP adequacy at multivariate analysis (adjusted OR 2.30, 95 %CI 1.67-3.16,p < 0.001) and was associated with higher median Boston Bowel Preparation Scale score (p < 0.001), higher rate of right-colon cleansing (p < 0.001) and exam completion (p = 0.04). Furthermore, we identified male sex, history of constipation, active smoking, previous pelvic surgery, concomitant psychiatric/neurological or chronic kidney diseases as predictors of inadequate BP. CONCLUSIONS: This is the largest real-world study comparing 1L-PEG to other BP regimens. Our results suggest 1L-PEG provides better BP in a non-controlled setting, improving clinical practice quality and minimizing the need for repeated colonoscopies and saving healthcare resources.
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Endoscopy plays a central role in diagnostic and therapeutic approaches to biliary disease in both benign and malignant conditions. A cholangioscope is an endoscopic instrument that allows for the direct exploration of the biliary tree. Over the years, technology has improved endoscopic image quality and allowed for the development of an operative procedure that can be performed during cholangioscopy. Different types of instruments are available in this context, and they can be used in different anatomical access points according to the most appropriate clinical indication. The direct visualization of biliary mucosa is essential in the presence of biliary strictures of unknown significance, allowing for the appropriate allocation of patients to surgery or conservative treatments. Cholangioscopy has demonstrated excellent performance in discriminating malignant conditions (such as colangiocarcinoma) from benign inflammatory strictures, and more recent advances (e.g., artificial intelligence and confocal laser endomicroscopy) could further increase its diagnostic accuracy. Cholangioscopy also plays a primary role in the treatment of benign conditions such as difficult bile stones (DBSs). In this case, it may not be possible to achieve complete biliary drainage using standard ERCP. Therapeutic cholangioscopy-guided lithotripsy allows for stone fragmentation and complete biliary drainage. Indeed, other complex clinical situations, such as patients with intra-hepatic lithiasis and patients with an altered anatomy, could benefit from the therapeutic role of cholangioscopy. The aim of the present review is to explore the most recent diagnostic and therapeutic advances in the roles of cholangioscopy in the management of biliary diseases.
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BACKGROUND: Hepatocellular carcinoma (HCC) is a leading cause of cancer-related death. Abdominal ultrasound (US) is by far the most widely used first-level exam for the diagnosis of HCC. We aimed to assess whether different ultrasound patterns were related to tumor prognosis. METHODS: We retrospectively reviewed all patients with a new diagnosis of HCC (single nodule) and undergoing radiofrequency thermal ablation (RFTA) at our clinic between January 2009 and December 2021. Patients were classified according to four HCC ultrasound patterns: 1A, single capsulated nodule; 1B, well capsulated intra-node nodule; 1C, cluster consisting of capsulated nodules; and 2, non-capsulated nodule. RESULTS: 149 patients were analysed; median follow-up time was 43 months. US patterns 1A (32.9%) and 1B (61.1%) were the most commonly seen. Median overall survival (OS) and recurrence-free survival (RFS) from RFTA were 54 months (95% CI, 42-66) and 22 months (95% CI, 12-32), respectively. Pattern 1A showed the best OS. Compared to pattern 1A, 1B was independently associated with worse OS (51 months (95% CI, 34-68) vs. 46 months (95% CI, 18-62)) and RFS (34 months (95% CI, 27-41) vs. 18 months (95% CI, 12-24)). Patterns 1C and 2 were associated with worse RFS compared to 1A, while no difference was seen for OS. Among baseline clinical variables, pattern 1B exhibited higher histological grade (p = 0.048) and tumor dimension (p = 0.034) compared to pattern 1A. CONCLUSIONS: Our findings demonstrate that different US patterns correlate with different survival outcomes and tumor behavior in patients with HCC. Prospective studies are needed to confirm these results.
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BACKGROUND: About 10%-30% of acute pancreatitis remain idiopathic (IAP) even after clinical and imaging tests, including abdominal ultrasound (US), contrast-enhanced computed tomography (CECT) and magnetic resonance cholangiopancreatography (MRCP). This is a relevant issue, as up to 20% of patients with IAP have recurrent episodes and 26% of them develop chronic pancreatitis. Few data are available on the role of EUS in clarifying the etiology of IAP after failure of one or more cross-sectional techniques. AIM: To evaluate the diagnostic gain after failure of one or more previous cross-sectional exams. METHODS: We retrospectively collected data about consecutive patients with AP and at least one negative test between US, CECT and MRCP, who underwent linear EUS between January 2017 and December 2020. We investigated the EUS diagnostic yield and the EUS diagnostic gain over different combinations of these cross-sectional imaging techniques for the etiologic diagnosis of AP. Types and frequency of EUS diagnosis were also analyzed, and EUS diagnosis was compared with the clinical parameters. After EUS, patients were followed-up for a median of 31.5 mo to detect cases of pancreatitis recurrence. RESULTS: We enrolled 81 patients (63% males, mean age 61 ± 18, 23% with previous cholecystectomy, 17% with recurrent pancreatitis). Overall EUS diagnostic yield for AP etiological diagnosis was 79% (20% lithiasis, 31% acute on chronic pancreatitis, 14% pancreatic solid or cystic lesions, 5% pancreas divisum, 5% autoimmune pancreatitis, 5% ductal abnormalities), while 21% remained idiopathic. US, CECT and MRCP, taken alone or in combination, led to AP etiological diagnosis in 16 (20%) patients; among the remaining 65 patients, 49 (75%) obtained a diagnosis at EUS, with an overall EUS diagnostic gain of 61%. Sixty-eight patients had negative US; among them, EUS allowed etiological diagnosis in 59 (87%). Sixty-three patients had a negative CECT; among them, 47 (74%) obtained diagnosis with EUS. Twenty-four had a negative MRCP; among them, 20 (83%) had EUS diagnosis. Twenty-one had negative CT + MRCP, of which 17 (81%) had EUS diagnosis, with a EUS diagnostic gain of 63%. Patients with biliary etiology and without previous cholecystectomy had higher median values of alanine aminotransferase (154 vs 25, P = 0.010), aspartate aminotransferase (95 vs 29, P = 0.018), direct bilirubin (1.2 vs 0.6, P = 0.015), gamma-glutamyl transpeptidase (180 vs 48, P = 0.006) and alkaline phosphatase (150 vs 72, P = 0.015) Chronic pancreatitis diagnosis was more frequent in patients with recurrent pancreatitis at baseline (82% vs 21%, P < 0.001). During the follow-up, AP recurred in 3 patients, one of which remained idiopathic. CONCLUSION: EUS is a good test to define AP etiology. It showed a 63% diagnostic gain over CECT + MRCP. In suitable patients, EUS should always be performed in cases of IAP. Further prospective studies are needed.
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Gastrointestinal tract is an uncommon site of breast cancer metastasis. Rectal linitis plastica (RLP) is a rare presentation of rectal neoplasia, both primary and secondary, and refers to a diffuse infiltration of the wall by an infiltrating carcinoma. Diagnostic assessment of RLP may be challenging since cross-sectional imaging and endoscopic findings may be nonspecific, and endoscopic biopsies are frequently non-diagnostic due to the submucosal disease localization. Endoscopic ultrasound (EUS) with fine needle biopsy (FNB) is widely used for the diagnostic assessment of sub-epithelial lesions of upper and lower gastrointestinal tract. However, data about the use of EUS in case of rectal linitis plastica are very poor. We present a case of rectal metastasis as the first presentation of lobular breast cancer, presenting as rectal linitis plastica and diagnosed with EUS-FNB.
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Neoplasias de la Mama , Carcinoma Lobular , Linitis Plástica , Neoplasias del Recto , Neoplasias Gástricas , Humanos , Femenino , Linitis Plástica/diagnóstico por imagen , Linitis Plástica/patología , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/patología , Carcinoma Lobular/diagnóstico por imagen , Carcinoma Lobular/secundario , Neoplasias del Recto/diagnóstico por imagen , Neoplasias del Recto/patología , Biopsia con Aguja Fina , Neoplasias Gástricas/patologíaRESUMEN
Gastroparesis is a chronic disease of the stomach that causes a delayed gastric emptying, without the presence of a stenosis. For 30 years the authors identified pylorospasm as one of the most important pathophysiological mechanisms determining gastroparesis. Studies with EndoFLIP, a device that assesses pyloric distensibility, increased the knowledge about pylorospasm. Based on this data, several pyloric-targeted therapies were developed to treat refractory gastroparesis: Surgical pyloroplasty and endoscopic approach, such as pyloric injection of botulinum and pyloric stenting. Notwithstanding, the success of most of these techniques is still not complete. In 2013, the first human gastric per-oral endoscopic myotomy (GPOEM) was performed. It was inspired by the POEM technique, with a similar dissection method, that allows pyloromyotomy. Therapeutical results of GPOEM are similar to surgical approach in term of clinical success, adverse events and post-surgical pain. In the last 8 years GPOEM has gained the attention of the scientific community, as a minimally invasive technique with high rate of clinical success, quickly prevailing as a promising therapy for gastroparesis. Not surprisingly, in referral centers, its technical success rate is 100%. One of the main goals of recent studies is to identify those patients that will respond better to the therapies targeted on pylorus and to choose the better approach for each patient.
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BACKGROUND: the assessment of fibrosis in Crohn's disease (CD) bowel lesions helps to guide therapeutic decisions. Real-time elastography (RTE) and delayed-enhancement magnetic resonance enterography (DE-MRE) have demonstrated good accuracy in quantifying CD-related ileal fibrosis as compared with histological examination. To date no study has compared DE-MRE and RTE. AIMS: we aimed to evaluate the agreement between RTE and DE-MRE on quantifying CD-related ileal fibrosis. METHODS: consecutive patients with ileal or ileocolonic CD underwent RTE and DE-MRE. Ileal fibrosis was quantified by calculating the strain ratio (SR) at RTE and the 70s-7 min percentage of enhancement gain (%EG) of both mucosa and submucosa at DE-MRE. A SR ≥2 was applied to define severe fibrosis. Clinically relevant outcomes occurring at follow-up were recorded. RESULTS: 40 CD patients were enrolled. A significant linear correlation was observed between SR and submucosal %EG (r = 0.594, p < 0.001). Patients with severe fibrosis (SR ≥2) had significantly higher submucosal %EG values than patients with low/moderate fibrosis (median values 26.4% vs. 9.5%, p < 0.001). During a median 43.8-month follow-up relevant disease outcomes occurred more frequently in the severe-fibrosis group (75% vs. 36%, HR 5.4, 95% CI 1.2-24.6, p = 0.029). CONCLUSIONS: the study demonstrates an excellent agreement between RTE and DE-MRE in assessing ileal fibrosis in CD.
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Enfermedad de Crohn/diagnóstico por imagen , Diagnóstico por Imagen de Elasticidad/estadística & datos numéricos , Íleon/patología , Mucosa Intestinal/patología , Imagen por Resonancia Magnética/estadística & datos numéricos , Adulto , Enfermedad de Crohn/patología , Estudios Transversales , Femenino , Fibrosis , Humanos , Íleon/diagnóstico por imagen , Mucosa Intestinal/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Reproducibilidad de los ResultadosRESUMEN
Introduction: Patients with inflammatory bowel disease (IBD) have a high risk of developing extra-intestinal manifestations (EIMs). We aimed to assess the cumulative incidence and clinical course of EIMs in patients treated with Vedolizumab (VDZ) and non-gut selective biologic drugs. Materials and methods: In this multicenter observational study, we enrolled 1,182 patients with IBD under biologic treatment in tertiary care centers, collecting the rate of new-onset EIMs and the clinical course of new and pre-existing EIMs since the introduction of the ongoing biologic drug (259 VDZ vs. 923 non-gut selective agents, median time 3 vs. 4 years). Results: Among 1,182 patients with IBD (median age of 46 years; 55% men) on biologics, the overall cumulative incidence of new onset EIMs was 4.1% (49/1,182), in particular 6.6% (17/259) on VDZ vs. 3.5% (32/923) on non-gut selective biologics (p = 0.02). Among 224 patients reporting new or pre-existing EIMs, those on VDZ showed a higher rate of clinical worsening compared with non-gut selective therapies (15.5 vs. 7.3%, p = 0.08). However, both showed a similar rate of modification of the therapeutic regimen. Female gender [hazard ratio (HR) 2.18], a longer course of ongoing biologic therapy (HR 1.18), ulcerative colitis (UC) (HR 1.83), and VDZ therapy (HR 1.85) were significant risk factors for developing new EIMs. Discussion: Our study suggests that the type of biologic treatment might affect the risk of developing EIMs, with a slightly higher risk in patients on gut-selective therapies. However, a similar clinical course is observed in the two groups.
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Data regarding double switching from originator infliximab (IFX) to IFX biosimilars in inflammatory bowel diseases (IBDs) are lacking. The purpose of this study was to evaluate the safety and efficacy of switching from originator IFX to CT-P13 and subsequently to SB2 (double switch) in patients with IBD. Patients undergoing IFX-double switch in eight Centers in Lombardy (Italy) from November 2018 to May 2019 were retrospectively analyzed. The IFX discontinuation rate, incidence and type of adverse events (AEs), and clinical remission rate were recorded. A comparison with a control group of patients with IBD single-switched from originator IFX to CT-P13 was performed, before and after an inverse probability of treatment weighting (IPTW)-based propensity score analysis. Fifty-two double-switched patients with IBD were enrolled. The 24- and 52-week proportions of patients continuing on IFX therapy following the second switch (CTP13 â SB2) were 98% (95% confidence interval [CI] 94%-100%) and 90% (95% CI 81%-99%), respectively. Four patients experienced a total of five AEs, all graded 1-3 according to Common Terminology Criteria for Adverse Events (CTCAE). No infusion reactions were observed. The 24-week and follow-up end clinical remission rates following the second switch were 94% and 88%, respectively. No differences were observed in the safety and efficacy outcomes by comparing the double-switch group with a single-switch group of 66 patients with IBD; all these results were confirmed by IPTW-adjusted analysis. The study suggests both the safety and efficacy of the double switch from originator IFX to CT-P13 and SB2 in patients with IBD is maintained. This strategy may be associated with potential cost implications.