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1.
Trials ; 24(1): 432, 2023 Jun 27.
Artículo en Inglés | MEDLINE | ID: mdl-37365665

RESUMEN

BACKGROUND: Stenosis is one of the most common complications in patients with Crohn's disease (CD). Endoscopic balloon dilation (EBD) is the treatment of choice for a short stenosis adjacent to the anastomosis from previous surgery. Self-expandable metal stents (SEMS) may be a suitable treatment option for longer stenoses. To date, however, there is no scientific evidence as to whether endoscopic (EBD/SEMS) or surgical treatment is the best approach for de novo or primary stenoses that are less than 10 cm in length. METHODS/DESIGN: Exploratory study as "proof-of-concept", multicentre, open-label, randomized trial of the treatment of de novo stenosis in the CD; endoscopic treatment (EBD/SEMS) vs surgical resection (SR). The type of endoscopic treatment will initially be with EDB; if a therapeutic failure occurs, then a SEMS will be placed. We estimate 2 years of recruitment and 1 year of follow-up for the assessment of quality of life, costs, complications, and clinical recurrence. After the end of the study, patients will be followed up for 3 years to re-evaluate the variables over the long term. Forty patients with de novo stenosis in CD will be recruited from 15 hospitals in Spain and will be randomly assigned to the endoscopic or surgical treatment groups. The primary aim will be the evaluation of the patient quality of life at 1 year follow-up (% of patients with an increase of 30 points in the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32). The secondary aim will be evaluation of the clinical recurrence rate, complications, and costs of both treatments at 1-year follow-up. DISCUSSION: The ENDOCIR trial has been designed to determine whether an endoscopic or surgical approach is therapeutically superior in the treatment of de novo stenosis in CD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04330846. Registered on 1 April 1 2020. https://clinicaltrials.gov/ct2/home.


Asunto(s)
Enfermedad de Crohn , Humanos , Enfermedad de Crohn/complicaciones , Enfermedad de Crohn/diagnóstico , Enfermedad de Crohn/cirugía , Constricción Patológica , Dilatación , Calidad de Vida , Resultado del Tratamiento , Stents/efectos adversos
3.
Immun Inflamm Dis ; 10(10): e710, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-36169258

RESUMEN

BACKGROUND: Previous studies suggested that Interleukin-10 (IL-10) depletion in Crohn's disease (CD) could predict outcome. AIM: To determine IL-10 in blood and at different intestinal locations in patients with active CD and to assess its potential prognostic capacity to identify aggressive CD. METHODS: Twenty-three patients with CD were included. Ulcerative colitis (UC), infectious colitis and healthy individuals acted as controls. Serum and mucosal samples were taken at baseline and 1 month after steroid initiation in CD patients. Patients were classified according to steroid response. Control samples were obtained from different intestinal locations. IL-10 expression was measured with real-time polymerase chain reaction, immunofluorescence (intestine) and ELISA (serum, biopsy cultures' supernatants and tissue homogenates). RESULTS: CD and UC showed an increase in IL-10 messenger RNA (mRNA) versus controls (p < .0001) in mucosa, whereas IL-10 protein secretion was increased in all types of intestinal inflammation (p < .001). No differences in IL-10 mRNA were found in CD at baseline regarding steroid response, but levels decreased in non-responders versus responders (p = .027) and were restored with rescue therapy. Serum IL-10 was increased in steroid-refractory CD at baseline and after treatment. CONCLUSIONS: Abnormal IL-10 levels in refractory patients in both mucosa and blood have physiopathological relevance and may have potential clinical applications.


Asunto(s)
Colitis Ulcerosa , Enfermedad de Crohn , Colitis Ulcerosa/metabolismo , Enfermedad de Crohn/tratamiento farmacológico , Enfermedad de Crohn/genética , Enfermedad de Crohn/metabolismo , Humanos , Interleucina-10/genética , Interleucina-10/metabolismo , Mucosa Intestinal/metabolismo , ARN Mensajero/genética , Esteroides/uso terapéutico
4.
Gastroenterol. hepatol. (Ed. impr.) ; 45(4): 315-334, Abr. 2022. tab, ilus, graf
Artículo en Español | IBECS | ID: ibc-204232

RESUMEN

A pesar de los avances farmacológicos, la estenosis en la Enfermedad de Crohn (EC) sigue siendo un problema importante que obliga en un alto porcentaje de pacientes a realizar tratamientos endoscópicos y/o quirúrgicos. No existen en la actualidad índices clínicos o herramientas diagnósticas que nos permitan predecir qué pacientes desarrollarán esta complicación, y actualmente cuando una estenosis se diagnostica, suele estar ya bien establecida y clínicamente relevante. El papel actual del tratamiento farmacológico se limita a tratar la inflamación y una vez que existe una fibrosis importante, las únicas opciones terapéuticas son las endoscópicas y/o quirúrgicas. Para poder establecer un correcto algoritmo terapéutico y con base en la evidencia científica disponible en este momento, el grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) ha decidido realizar este documento de posicionamiento sobre el tratamiento de la estenosis en la EC. Este documento abarca los tres abordajes terapéuticos mencionados, médico, endoscópico y quirúrgico. Se establecen recomendaciones y algoritmos terapéuticos que nos permitan ayudar a elegir la opción más adecuada en función de las características de la estenosis y del paciente.(AU)


Despite pharmacological advances, strictures in Crohn's disease (CD) continues to be an important problem that leads in a high percentage of patients to undergo endoscopic and/or surgical treatments. There are currently no clinical scores or diagnostic tools that allow predicting which patients will develop this complication, and when a stricture is diagnosed, it is usually already well established and clinically relevant. The current role of pharmacological treatment is limited to treat inflammation and once there is significant fibrosis, the only therapeutic options are endoscopic and/or surgical. To establish a correct therapeutic algorithm and based on the current scientific evidence available, the Spanish Group Working on Crohn's Disease and Ulcerative Colitis (GETECCU) has decided to conduct this position statement on the treatment of strictures in CD. This document embraces the three mentioned therapeutic approaches, medical, endoscopic and surgical. Recommendations and therapeutic algorithms are established to help us to choose the most appropriate option based on the characteristics of the stricture and the patient.(AU)


Asunto(s)
Humanos , Enfermedad de Crohn/complicaciones , Enfermedad de Crohn/diagnóstico , Enfermedad de Crohn/terapia , Colitis Ulcerosa/cirugía , Colitis Ulcerosa/terapia , Malformaciones Anorrectales , Terapéutica , Endoscopía , Cirugía General , Gastroenterología
7.
Trials ; 23(1): 181, 2022 Feb 25.
Artículo en Inglés | MEDLINE | ID: mdl-35216619

RESUMEN

BACKGROUND: It is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing meal stent (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency. The aim of this study is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (BD) for the management of distal malignant biliary obstruction. METHODS/DESIGN: This is a multicenter open-label, randomized controlled trial with two parallel groups. Eighty-four patients with malignant biliary obstruction will undergo EUS-BD (CDS type) using LAMS in 7 tertiary hospitals in Spain and will be randomized to the LAMS and LAMS plus DPS groups. The primary endpoint is the rate of recurrent biliary obstruction, as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin > 50% within 14 days of stent placement), safety, and others (number of reinterventions, time to biliary obstruction, prognostic factors, survival rate). DISCUSSION: The BAMPI trial has been designed to determine whether the addition of a coaxial axis-orienting DPS through LAMS is superior to LAMS alone to prevent stent dysfunction. TRIAL REGISTRATION: ClinicalTrials.gov NCT04595058 . Registered on October 14, 2020.


Asunto(s)
Colestasis , Endosonografía , Colestasis/diagnóstico por imagen , Colestasis/etiología , Colestasis/cirugía , Drenaje/métodos , Endosonografía/métodos , Humanos , Estudios Multicéntricos como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Stents , Ultrasonografía Intervencional/métodos
8.
Gastroenterol. hepatol. (Ed. impr.) ; 45(2): 91-98, Feb. 2022. tab, graf
Artículo en Inglés | IBECS | ID: ibc-204136

RESUMEN

Introduction: Endoscopic ultrasound (EUS) is a more sensitive technique than transabdominal ultrasound for the diagnosis of gallstones. This greater sensitivity, especially in the diagnosis of microlithiasis/biliary sludge, facilitates the indication of cholecystectomy in patients with symptoms of probable biliary origin but may result in over-indication of this surgery.Objectives: Evaluate the role of EUS in the diagnosis of minilithiasis/biliary sludge in patients with digestive symptoms of probable biliary origin by resolving the symptoms after cholecystectomy. Analyse factors related to the remission of symptoms following cholecystectomy.Patients and methods: Retrospective, longitudinal, single-centre study based on a prospective database of 1.121 patients undergoing EUS. Seventy-four patients were identified as meeting inclusion-exclusion criteria (diagnosed with minilithiasis/sludge by EUS after presenting digestive symptoms of probable biliary origin without a history of complicated cholelithiasis). A telephone questionnaire for symptoms was conducted with cholecystectomized patients. Factors related to a good response were analysed with logistic regression analysis.Results: Of the 74 patients, 50 were cholecystectomized (67.5%), mean age 49 years (SEM 2.26) (41 women). Seventy percent of patients (35/50) presented remission of symptoms with median follow-up 353.5 days (95% CI, 270–632.2). The only variable associated with remission of symptoms was the presence of typical biliary colic with an OR of 7.8 (95% CI, 1.8–34; p=0.006). No complications associated with EUS were recorded. One patient (2%) suffered haemoperitoneum and 18% (9/50) suffered diarrhoea following cholecystectomy.Conclusions: EUS is a very useful technique for the indication of cholecystectomy in patients with minilithiasis/sludge and typical symptoms of biliary colic.


Introducción: La ecoendoscopia (USE) presenta mayor sensibilidad que la ecografía abdominal para el diagnóstico de litiasis biliar. Esta mayor sensibilidad, sobre todo en diagnóstico de microlitiasis/barro biliar, facilitaría una colecistectomía en pacientes con clínica digestiva de probable origen biliar, aunque podría inducir su sobre indicación.ObjetivosEvaluar el papel de la USE en el diagnóstico de minilitiasis-barro biliar en pacientes con clínica digestiva de probable origen biliar y ecografía normal mediante la resolución de los síntomas después de colecistectomía. Analizar los factores relacionados con la remisión de la sintomatología tras colecistectomía.Pacientes y método: Estudio retrospectivo, longitudinal, en un centro, sobre base de datos prospectiva de 1.121 pacientes sometidos a USE. Setenta y cuatro pacientes cumplían criterios inclusión-exclusión (realización USE para estudio de minilitiasis/barro por síntomas digestivos de probable origen biliar, sin historia de colelitiasis complicada). Se realizó cuestionario telefónico de síntomas a los pacientes colecistectomizados. Los factores relacionados con buena evolución se analizaron con análisis de regresión logística.Resultados: De los 74 pacientes, 50 fueron colecistectomizados (67,5%), edad media 49 años (ESM 2,26) (41 mujeres). El 70% de pacientes (35/50) presentó remisión de la sintomatología (mediana de seguimiento 353,5 días) (IC 95%, 270-632,2). La única variable asociada con una remisión de la sintomatología fue la presencia de cólico biliar típico con una OR de 7,8 (IC 95%, 1,8-34; p=0,006). No se registró ninguna complicación asociada a la USE. Un paciente (2%) sufrió hemoperitoneo y un 18% (9/50) presentaron diarrea post-colecistectomía.Conclusiones: La USE es de gran utilidad para la indicación de colecistectomía en los pacientes con minilitiasis-barro biliar y clínica típica de cólico biliar.


Asunto(s)
Humanos , Adulto , Endosonografía , Colecistectomía , Colelitiasis , Bilis/diagnóstico por imagen , Colecistectomía/efectos adversos , Colecistectomía/estadística & datos numéricos , Diarrea , Complicaciones Posoperatorias , Estudios Retrospectivos , Gastroenterología , Estudios Longitudinales , Encuestas y Cuestionarios
9.
Lancet Gastroenterol Hepatol ; 7(4): 332-341, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-35065738

RESUMEN

BACKGROUND: Endoscopic balloon dilation (EBD) is the established endoscopic treatment for short strictures in Crohn's disease. Fully covered self-expandable metal stents (FCSEMS) have been used for endoscopic treatment of patients for whom EBD was unsuccessful. We aimed to determine the efficacy and safety of the two endoscopic treatments in patients with Crohn's disease with stenosis and compare the mean cost of both treatments. METHODS: This multicentre, open-label, randomised trial was done in 19 tertiary and secondary hospitals in Spain. Patients with Crohn's disease with obstructive symptoms and predominantly fibrotic strictures of less than 10 cm in length were eligible for inclusion. We excluded patients with stenosis treated with SEMS or EBD in the previous year and stenosis not accessible to a colonoscope. Patients were randomly assigned (1:1) to receive either EBD (EBD group) or FCSEMS (FCSEMS group) using a digital en-block randomisation system (block size of four). In the EBD group, dilation was done with a CRE Boston Scientific (Marlborough, MA, USA) pneumatic balloon with the diameter set at the discretion of the endoscopist; a maximum of two sessions of dilation were allowed with a minimum interval of 15-30 days between them. In the FCSEMS group, a 20 mm diameter Taewoong (Gimpo-si, South Korea) fully covered metal stent was placed; stent length was set at the discretion of the endoscopist. The primary outcome was to assess the efficacy of the endoscopic treatment, defined by the proportion of patients free of a new therapeutic intervention (EBD, FCSEMS, or surgery) due to symptomatic recurrence at 1 year of follow-up. Patients were analysed according to the intention-to-treat principle. Adverse events were recorded for all the patients; events were considered associated to be with the procedure when a causal association was possible, probable, or definite. This trial is registered with ClinicalTrials.gov, NCT02395354. FINDINGS: From Aug 28, 2013, to Oct 9, 2017, we assessed the eligibility of 99 patients, of whom 19 (19%) patients were excluded. Thus, 80 (81%) patients were randomly assigned to treatment: 39 (49%) patients to the FCSEMS group and 41 (51%) patients to the EBD group. 33 (80%) of 41 patients in the EBD group and 20 (51%) of 39 patients in the FCSEMS group were free of a new therapeutic intervention at 1 year (odds ratio [OR] 3·9 [95% CI 1·4-10·6]; p=0·0061). Two (3%) of 80 patients had severe adverse events (one [2%] patient in the EBD group and one [3%] patient in the FCSEMS group); both patients had perforations. INTERPRETATION: EBD is more effective than FCSEMS for Crohn's disease strictures, with a good safety profile for both treatments. FUNDING: Spanish National Institute of Health, Foundation of Spanish Society of Digestive Endoscopy, Catalan Society of Gastroenterology, and Taweoong.


Asunto(s)
Enfermedad de Crohn , Constricción Patológica/etiología , Constricción Patológica/terapia , Enfermedad de Crohn/complicaciones , Enfermedad de Crohn/terapia , Dilatación/efectos adversos , Dilatación/métodos , Endoscopía Gastrointestinal/métodos , Humanos , Stents/efectos adversos , Resultado del Tratamiento
10.
Gastroenterol Hepatol ; 45(2): 91-98, 2022 Feb.
Artículo en Inglés, Español | MEDLINE | ID: mdl-34023476

RESUMEN

INTRODUCTION: Endoscopic ultrasound (EUS) is a more sensitive technique than transabdominal ultrasound for the diagnosis of gallstones. This greater sensitivity, especially in the diagnosis of microlithiasis/biliary sludge, facilitates the indication of cholecystectomy in patients with symptoms of probable biliary origin but may result in over-indication of this surgery. OBJECTIVES: Evaluate the role of EUS in the diagnosis of minilithiasis/biliary sludge in patients with digestive symptoms of probable biliary origin by resolving the symptoms after cholecystectomy. Analyse factors related to the remission of symptoms following cholecystectomy. PATIENTS AND METHODS: Retrospective, longitudinal, single-centre study based on a prospective database of 1.121 patients undergoing EUS. Seventy-four patients were identified as meeting inclusion-exclusion criteria (diagnosed with minilithiasis/sludge by EUS after presenting digestive symptoms of probable biliary origin without a history of complicated cholelithiasis). A telephone questionnaire for symptoms was conducted with cholecystectomized patients. Factors related to a good response were analysed with logistic regression analysis. RESULTS: Of the 74 patients, 50 were cholecystectomized (67.5%), mean age 49 years (SEM 2.26) (41 women). Seventy percent of patients (35/50) presented remission of symptoms with median follow-up 353.5 days (95% CI, 270-632.2). The only variable associated with remission of symptoms was the presence of typical biliary colic with an OR of 7.8 (95% CI, 1.8-34; p=0.006). No complications associated with EUS were recorded. One patient (2%) suffered haemoperitoneum and 18% (9/50) suffered diarrhoea following cholecystectomy. CONCLUSIONS: EUS is a very useful technique for the indication of cholecystectomy in patients with minilithiasis/sludge and typical symptoms of biliary colic.


Asunto(s)
Bilis/diagnóstico por imagen , Colecistectomía/estadística & datos numéricos , Endosonografía , Cálculos Biliares/diagnóstico por imagen , Colecistectomía/efectos adversos , Cólico/epidemiología , Diarrea/epidemiología , Femenino , Cálculos Biliares/cirugía , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Inducción de Remisión , Estudios Retrospectivos , Evaluación de Síntomas
11.
Gastroenterol Hepatol ; 45(4): 315-334, 2022 Apr.
Artículo en Inglés, Español | MEDLINE | ID: mdl-34274357

RESUMEN

Despite pharmacological advances, strictures in Crohn's disease (CD) continues to be an important problem that leads in a high percentage of patients to undergo endoscopic and/or surgical treatments. There are currently no clinical scores or diagnostic tools that allow predicting which patients will develop this complication, and when a stricture is diagnosed, it is usually already well established and clinically relevant. The current role of pharmacological treatment is limited to treat inflammation and once there is significant fibrosis, the only therapeutic options are endoscopic and/or surgical. To establish a correct therapeutic algorithm and based on the current scientific evidence available, the Spanish Group Working on Crohn's Disease and Ulcerative Colitis (GETECCU) has decided to conduct this position statement on the treatment of strictures in CD. This document embraces the three mentioned therapeutic approaches, medical, endoscopic and surgical. Recommendations and therapeutic algorithms are established to help us to choose the most appropriate option based on the characteristics of the stricture and the patient.


Asunto(s)
Colitis Ulcerosa , Enfermedad de Crohn , Colitis Ulcerosa/cirugía , Colitis Ulcerosa/terapia , Constricción Patológica/complicaciones , Constricción Patológica/terapia , Enfermedad de Crohn/complicaciones , Enfermedad de Crohn/diagnóstico , Enfermedad de Crohn/terapia , Endoscopía/efectos adversos , Humanos , Inflamación/complicaciones
12.
BMC Gastroenterol ; 21(1): 334, 2021 Aug 26.
Artículo en Inglés | MEDLINE | ID: mdl-34445965

RESUMEN

BACKGROUND: SARS-CoV-2 may produce intestinal symptoms that are generally mild, with a small percentage of patients developing more severe symptoms. The involvement of SARS-CoV-2 in the physiopathology of bowel damage is poorly known. Transmission electron microscopy (TEM) is a useful tool that provides an understanding of SARS-CoV-2 invasiveness, replication and dissemination in body cells but information outside the respiratory tract is very limited. We report two cases of severe intestinal complications (intestinal lymphoma and ischaemic colitis) in which the presence of SARS-CoV-2 in intestinal tissue was confirmed by TEM. These are the first two cases reported in the literature of persistence of SARS-CoV-2 demonstrated by TEM in intestinal tissue after COVID 19 recovery and SARS-CoV-2 nasopharyngeal clearance. CASE PRESENTATION: During the first pandemic peak (1st March-30th April 2020) 932 patients were admitted in Hospital Universitari Mútua Terrassa due to COVID-19, 41 (4.4%) required cross-sectional imaging techniques to assess severe abdominal pain and six of them (0.64%) required surgical resection. SARS-CoV-2 in bowel tissue was demonstrated by TEM in two of these patients. The first case presented as an ileocaecal inflammatory mass which turned to be a B-cell lymphoma. Viral particles were found in the cytoplasm of endothelial cells of damaged mucosa. In situ hybridization was negative in tumour cells, thus ruling out an oncogenic role for the virus. SARS-CoV-2 remained in intestinal tissue 6 months after nasopharyngeal clearance, suggesting latent infection. The second patient had a severe ischaemic colitis with perforation and SARS-CoV-2 was also identified in endothelial cells. CONCLUSIONS: Severe intestinal complications associated with COVID-19 are uncommon. SARS-CoV-2 was identified by TEM in two cases, suggesting a causal role in bowel damage.


Asunto(s)
COVID-19 , SARS-CoV-2 , Dolor Abdominal , Células Endoteliales , Humanos , Microscopía Electrónica de Transmisión
13.
Nutrients ; 13(5)2021 May 15.
Artículo en Inglés | MEDLINE | ID: mdl-34063411

RESUMEN

INTRODUCTION: The study of intraepithelial lymphocytes (IEL) by flow cytometry is a useful tool in the diagnosis of coeliac disease (CD). Previous data showed that an increase in %TCRγδ+ and decrease of %CD3- IEL constitute a typical CD cytometric pattern with a specificity of 100%. However, there are no data regarding whether there are differences in the %TCRγδ+ related to sex, age, titers of serology, and degree of histological lesion. STUDY AIMS: To confirm the high diagnostic accuracy of the coeliac cytometric patterns. To determine if there are differences between sex, age, serology titers, and histological lesion grade. RESULTS: We selected all patients who fulfilled "4 of 5" rule for CD diagnosis (n = 169). There were no differences in %TCRγδ+ between sexes (p = 0.909), age groups (p = 0.986), serology titers (p = 0.53) and histological lesion grades (p = 0.41). The diagnostic accuracy of complete CD cytometric pattern was: specificity 100%, sensitivity 82%, PPV 100%, NPV 47%. CONCLUSION: We confirmed, in a validation cohort, the high diagnostic accuracy of complete CD pattern irrespective of sex, age, serology titers, and grade of mucosal lesion.


Asunto(s)
Enfermedad Celíaca/diagnóstico , Enfermedad Celíaca/inmunología , Linfocitos Intraepiteliales/inmunología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Biopsia , Niño , Preescolar , Estudios de Cohortes , Femenino , Citometría de Flujo , Humanos , Inmunoglobulina A/sangre , Masculino , Persona de Mediana Edad , Receptores de Antígenos de Linfocitos T gamma-delta , Adulto Joven
14.
Surg Endosc ; 35(8): 4873-4881, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-33721090

RESUMEN

BACKGROUND: There are uncertainties concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within lumen-apposing metal stents (LAMS) in EUS-guided choledochoduodenostomy (CDS). The aim of this study was to determine whether a DPS within a biliary LAMS offers a potential benefit in EUS-guided CDS for the palliative management of malignant biliary obstruction. METHODS: This was a multicentre retrospective study at three tertiary institutions. PERIOD: May 2015 to August 2020. Two interventional strategies (LAMS alone and LAMS plus DPS) were compared. The choice was the endoscopist's discretion. Inclusion: unresectable/inoperable biliopancreatic tumours with previous failed ERCP. Clinical success: bilirubin decrease > 30% at 4 weeks. RESULTS: Forty-one consecutive cases of EUS-CDS using biliary LAMS were treated (22 women; mean age, 72.3 years) during the study period. The procedure was technically successful in 39 (95.1%), who were managed using the two strategies (22 LAMS alone; 17 LAMS plus DPS). No differences between the groups, in terms of clinical success (77.3 vs 87.5%, p = 0.67), adverse events (AEs, 13.6 vs 11.8%, p = 0.99), recurrent biliary obstruction (RBO, 13.6 vs 23.5%, p = 0.67), or survival rate (p = 0.67) were encountered. The LAMS alone group had a shorter length of procedure (50 min vs 66 min, p = 0.102). No risk factors related to clinical success, AEs, RBO, or survival were detected. CONCLUSIONS: The technical variant of adding a coaxial DPS within LAMS in EUS-CDS seems not to be enough to prevent biliary morbidities, and it is a time-consuming strategy. Although prospective studies are needed, these results do not support its routine use.


Asunto(s)
Colestasis , Neoplasias , Anciano , Colestasis/etiología , Colestasis/cirugía , Drenaje , Endosonografía , Femenino , Humanos , Masculino , Plásticos , Estudios Retrospectivos , Stents
15.
Gastroenterology ; 158(6): 1642-1649.e1, 2020 05.
Artículo en Inglés | MEDLINE | ID: mdl-31972236

RESUMEN

BACKGROUND & AIMS: Guidelines recommend routine antibiotic prophylaxis for patients undergoing endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) of pancreatic cysts, but there is conflicting evidence for its necessity. We investigated whether performing the procedure without antimicrobial prophylaxis increases the incidence of infection. METHODS: We performed a multicenter, randomized, noninferiority trial to compare prophylaxis with ciprofloxacin vs placebo in patients with a pancreatic cyst requiring EUS-FNA at multiple centers in Spain. From September 2014 to June 2018, patients were randomly assigned to groups that received the prophylaxis with ciprofloxacin (n = 112) or saline solution (n = 114, placebo). We recorded patients' demographic data, lesion characteristics, and procedure data and followed patients for 21 days. A total of 205 patients completed the trial (90.7%), receiving ciprofloxacin or the control, with no statistically significant differences in demographics, baseline data, or procedure characteristics between groups. The primary outcome was FNA-related infection. Secondary outcomes were incidence of fever, procedure complications, and medication-related adverse events. RESULTS: The only case of FNA-related infection (0.44%) occurred in a patient in the placebo group (0.87%); this patient developed acute pancreatitis and bacteremia after the procedure. Prevention of infection was not inferior in the control group; the difference between proportions was 0.87% (95% confidence interval, -0.84% to 2.59%). There were no differences between groups in fever (2 patients in each group: 1.78% vs 1.76%; P = 1.00) or other adverse events. CONCLUSIONS: In a randomized trial of patients undergoing EUS-FNA for pancreatic cyst evaluation, we found the risk of infection to be low. The incidence of infections did not differ significantly with vs without ciprofloxacin prophylaxis. (ClinicalTrials.gov, Number: NCT02261896).


Asunto(s)
Antibacterianos/administración & dosificación , Profilaxis Antibiótica/normas , Biopsia por Aspiración con Aguja Fina Guiada por Ultrasonido Endoscópico/efectos adversos , Quiste Pancreático/diagnóstico , Complicaciones Posoperatorias/prevención & control , Cuidados Preoperatorios/normas , Anciano , Ciprofloxacina/administración & dosificación , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Páncreas/diagnóstico por imagen , Páncreas/patología , Quiste Pancreático/patología , Placebos/administración & dosificación , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/microbiología , Guías de Práctica Clínica como Asunto , Cuidados Preoperatorios/métodos , España
16.
Surg Endosc ; 34(3): 1112-1122, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-31144122

RESUMEN

BACKGROUND: There is no information regarding the outcome of Crohn's disease (CD) patients treated with endoscopic balloon dilation (EBD) in non-referral hospitals, nor on the efficacy of EBD in ulcerative colitis (UC). We report herein the results of the largest series published to date. AIM: To assess the efficacy and safety of EBD for inflammatory bowel disease (IBD) stenosis performed in 19 hospitals with different levels of complexity and to determine factors related to therapeutic success. METHODS: We identified IBD patients undergoing EBD in the ENEIDA database. Efficacy of EBD was compared between CD and UC and between secondary and tertiary hospitals. Predictive factors of therapeutic success were assessed with multivariate analysis. RESULTS: Four-hundred dilations (41.2% anastomotic) were performed in 187 IBD patients (13 UC/Indeterminate colitis). Technical and therapeutic success per dilation was achieved in 79.5% and 55.3%, respectively. Therapeutic success per patient was achieved in 78.1% of cases (median follow-up: 40 months) with 49.7% requiring more than one dilation. No differences related to either diagnosis or hospital complexity was found. Technical success [OR 4.12 (95%CI 2.4-7.1)] and not receiving anti-TNF at the time of dilation [OR 1.7 (95% CI 1.1-2.6)] were independently related to therapeutic success per dilation. A stricture length ≤ 2 cm [HR 2.43 (95% CI 1.11-5.31)] was a predictive factor of long-term success per patient. The rate of major complications was 1.3%. CONCLUSIONS: EBD can be performed with similar efficacy and safety in hospitals with differing levels of complexity and it might be a suitable treatment for UC with short stenosis. To achieve a technical success and the short length of the stenosis seem to be critical for long-term therapeutic success.


Asunto(s)
Colitis Ulcerosa/cirugía , Enfermedad de Crohn/cirugía , Endoscopía Gastrointestinal/efectos adversos , Sistema de Registros , Colitis Ulcerosa/complicaciones , Constricción Patológica/etiología , Enfermedad de Crohn/complicaciones , Dilatación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Probabilidad , Centros de Atención Terciaria , Resultado del Tratamiento
18.
Dig Liver Dis ; 51(12): 1646-1651, 2019 12.
Artículo en Inglés | MEDLINE | ID: mdl-31383457

RESUMEN

BACKGROUND: Information on the use of fecal markers in microscopic colitis screening is limited. AIM: To evaluate the risk variables associated with a diagnosis of microscopic colitis including fecal calprotectin. METHODS: Patients submitted for a colonoscopy due to chronic watery diarrhea fulfilling criteria of functional disease were evaluated. Colonic mucosa was normal but mild erythema and edema was allowed. Fecal calprotectin was analyzed. A logistic regression was used to evaluate variables associated with both raised fecal calprotectin and a diagnosis of microscopic colitis. RESULTS: 94 patients were included, 30 were diagnosed with microscopic colitis and 64 made up the control group. Median calprotectin levels were 175 (IQR, 59-325) for the microscopic colitis and 28 (IQR, 16-111) for the control group (p < 0.001). The optimal cut-off for fecal calprotectin was >100 µg/g (AUC, 0.73), with 67% sensitivity and 75% specificity. The number of drugs used ≥3 (OR, 3.9; CI, 1.4-10.4) and microscopic colitis diagnosis (OR, 6; CI, 2.2-16.3) were associated with raised calprotectin levels. Age >60 years (OR, 3.8; CI, 1.4-10.1) and calprotectin levels (OR, 5.3; CI, 2-14.1) were associated with a risk of microscopic colitis. CONCLUSIONS: Elevated fecal calprotectin concentrations are often seen in microscopic colitis, and may be helpful in the diagnosis of women over 60 with chronic watery diarrhea.


Asunto(s)
Colitis Microscópica , Colonoscopía , Diarrea , Heces , Mucosa Intestinal , Complejo de Antígeno L1 de Leucocito/análisis , Factores de Edad , Biomarcadores/análisis , Biopsia/métodos , Estudios de Cohortes , Colitis Microscópica/diagnóstico , Colitis Microscópica/epidemiología , Colitis Microscópica/patología , Colonoscopía/métodos , Colonoscopía/estadística & datos numéricos , Diarrea/diagnóstico , Diarrea/epidemiología , Diarrea/etiología , Diarrea/fisiopatología , Femenino , Humanos , Mucosa Intestinal/metabolismo , Mucosa Intestinal/patología , Masculino , Persona de Mediana Edad , Factores Sexuales , España/epidemiología
20.
J Crohns Colitis ; 10(9): 1042-54, 2016 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-26995182

RESUMEN

BACKGROUND AND AIMS: There is very limited information regarding region-specific immunological response in human intestine. We aimed to determine differences in immune compartmentalisation between ileum and colon in healthy and inflamed mucosa. METHODS: T cell profile and its apoptosis were measured by flow cytometry, Th1, Th17, Treg [CD4(+)CD25(+)FOXP3(+)], double positive [DP, CD3(+)CD4(+)CD8(+)] and double negative T cells [DN, CD3(+)CD4(-)CD8(-)], immunohistochemistry [FOXP3, caspase-3], and real-time polymerase chain reaction [PCR] [IFN-γ, IL-17-A, and FOXP3] on biopsies from different regions of healthy intestine and of intestine in inflammatory bowel diseases. RESULTS: Healthy colon showed higher percentages of Treg, Th17, and DN, and lower numbers of DP T cells compared with ileum [p < 0.05]. Some but not all region-specific differences were lost in inflammatory conditions. Disease-specific patterns were found: a Th1/Th17 pattern and a Th17 pattern in Crohn's disease and ulcerative colitis respectively, whereas a reduction in Th1/Th17 was found in microscopic colitis. In colonic Crohn's disease and microscopic colitis, DN T cells had a pattern inverse to that of Th1/Th17 (increase in microscopic colitis [p < 0.05] and decrease in Crohn's disease [p < 0.005]). Higher levels of lymphocyte apoptosis were found in healthy colon compared with the ileal counterparts [p = 0.001]. All forms of colonic inflammation presented a dramatic decrease in apoptosis compared with healthy colon. By contrast ileal Crohn's disease showed higher levels of cleaved-Caspase(+) CD3(+) cells. CONCLUSIONS: Immunological differences exist in healthy gastrointestinal tract. Inflammatory processes overwhelm some location-specific differences, whereas others are maintained. Care has to be taken when analysing immune response in intestinal inflammation, as location-specific differences may be relevant.


Asunto(s)
Apoptosis/inmunología , Colon/inmunología , Íleon/inmunología , Enfermedades Inflamatorias del Intestino/inmunología , Mucosa Intestinal/inmunología , Subgrupos de Linfocitos T/metabolismo , Adulto , Anciano , Biomarcadores/metabolismo , Estudios de Casos y Controles , Colon/metabolismo , Colon/patología , Femenino , Citometría de Flujo , Humanos , Íleon/metabolismo , Íleon/patología , Inmunohistoquímica , Enfermedades Inflamatorias del Intestino/metabolismo , Enfermedades Inflamatorias del Intestino/patología , Mucosa Intestinal/metabolismo , Mucosa Intestinal/patología , Masculino , Persona de Mediana Edad , Reacción en Cadena en Tiempo Real de la Polimerasa
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