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1.
Scand J Gastroenterol ; 58(1): 20-24, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-35929993

RESUMO

BACKGROUND: Family history increases the risk for inflammatory bowel diseases (IBDs). However, data on differences in phenotypic characteristics among patients with a strong family history of IBD are scarce and controversial. The aim of the study was to compare the phenotypic features of IBD patients with four or more affected first-degree relatives with sporadic cases of IBD. METHODS: Patients with familial and sporadic IBD were identified from the institutional IBD database. IBD patients from families with at least four first-degree affected relatives were selected for analysis and were compared to non-matched sporadic cases with IBD chosen randomly. Comparison for type of IBD (Crohn's disease (CD) vs. ulcerative colitis (UC)), age at onset as well as for disease extent, behavior, extraintestinal manifestations and indicators of severe disease were analyzed. RESULTS: Thirty-five patients with familial IBD (28 CD, seven UC) were compared to 88 sporadic IBD patients (61 CD, 24 UC and three IBDU). Disease duration was 10.3 ± 8.2 in the familial and 8.0 ± 7.2 years in the sporadic cases, p=.13. The familial cases were younger at diagnosis (19.3 ± 8.6 vs. 25.7 ± 11.8, p=.004). Patients with familial compared to sporadic IBD were significantly more likely to require steroid treatment (80% vs. 54.5%, p=.009), biological treatment (94.3%, vs. 63.6%, p<.001) or surgery (25.7%, vs. 11.4%, p=.048). CONCLUSIONS: IBD with a very strong positive family history is associated with younger age at onset and a more adverse IBD phenotype compared to sporadic IBD.


Assuntos
Colite Ulcerativa , Doença de Crohn , Doenças Inflamatórias Intestinais , Humanos , Colite Ulcerativa/epidemiologia , Colite Ulcerativa/genética , Colite Ulcerativa/terapia , Doença de Crohn/terapia , Doenças Inflamatórias Intestinais/epidemiologia , Doenças Inflamatórias Intestinais/genética , Fenótipo
2.
Ann Hepatol ; 28(3): 100897, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36632976

RESUMO

INTRODUCTION AND OBJECTIVES: Novel predictors of prognosis in cirrhotic patients have been emerging in recent years and studies show that the lactate/albumin ratio can serve as an early prognostic marker in different patient groups. We aimed to uncover the clinical significance of the lactate/albumin ratio in hospitalized patients with acutely decompensated cirrhosis. MATERIALS AND METHODS: A retrospective single-center cohort study was conducted in a tertiary medical center. Subjects included had an established diagnosis of liver cirrhosis and were admitted to the ICU or the Internal Medicine department with a clinical picture of acute-on-chronic liver failure between the years 2010 and 2021. The primary outcome was to assess the utility of the lactate/albumin ratio as a prognostic marker to predict mortality in hospitalized cirrhotic patients with acute-on-chronic hepatic failure. RESULTS: Two hundred seventy-nine patients were included in this study. Univariate analysis revealed that mean WBC count, platelet/creatinine ratio, aspartate transaminase (AST), lactate, and MELD score were all significantly associated with the primary outcome. Multivariate analysis showed that the lactate/albumin ratio was the strongest statistically significant (p < 0.001) predictor of death during hospitalization - OR 13.196 (95% CI 3.6-48.3), followed by mean WBC count, MELD score, and serum lactate levels. A ROC curve was constructed, which resulted in an area under the curve (AUC) equal to 0.77. Crosstabs from the ROC showed a sensitivity of 66.7% and a specificity of 76.2% when the lactate/albumin ratio chosen as a cutoff was 0.9061 CONCLUSIONS: Elevated lactate/albumin ratio predicts in-hospital mortality in hospitalized cirrhotics with acute-on-chronic hepatic failure.


Assuntos
Insuficiência Hepática Crônica Agudizada , Ácido Láctico , Humanos , Estudos de Coortes , Estudos Retrospectivos , Mortalidade Hospitalar , Prognóstico , Cirrose Hepática/complicações , Albuminas , Insuficiência Hepática Crônica Agudizada/diagnóstico , Curva ROC
3.
Isr Med Assoc J ; 25(3): 191-195, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36946663

RESUMO

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is one of the most prevalent chronic liver disorders. Acute cholangitis (AC) is a life-threatening illness. OBJECTIVES: To determine whether NAFLD is a risk factor for the severity of AC. METHODS: We retrospectively studied hospitalized patients with a diagnosis of AC over 5 years. Patients were divided into a NAFLD group and a non-NAFLD group. We compared the two groups with regard to demographic characteristics, co-morbidities, laboratory data, and severity of AC (including Charlson Comorbidity Index [CCI] and Tokyo Consensus meeting criteria). RESULTS: In all, 298 of 419 hospitalized patients diagnosed with AC met the inclusion criteria. Of these, 73/298 (24.5%) were in the NAFLD group. NAFLD group patients were younger and more likely to be diabetic and obese than the non-NAFLD group. Participants in the NAFLD presented with higher serum C-reactive protein and higher liver enzymes (P < 0.05, for each parameter) and with more events of organ dysfunction (P < 0.001) and bacteremia (P < 0.005). Regarding the severity of AC according to Tokyo Consensus, among the NAFLD group more patients presented with Grade II (39.7 vs. 33.3%, P < 0.001) and Grade III (23.3 vs. 18.3, P < 0.001) cholangitis. More Grade I cholangitis was found among the non-NAFLD group (48.4 vs. 37%, P < 0.001). Multivariate logistic regression analysis showed that NAFLD was independently associated with severe AC, Grade III (odds ratio 3.25, 95% confidence interval 1.65-6.45, P = 0.038). CONCLUSIONS: NAFLD is an independent risk factor for the severity of AC.


Assuntos
Colangite , Hepatopatia Gordurosa não Alcoólica , Humanos , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Estudos Retrospectivos , Fatores de Risco , Comorbidade , Colangite/epidemiologia , Índice de Gravidade de Doença , Fígado
4.
Surg Endosc ; 36(4): 2412-2417, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-33977375

RESUMO

BACKGROUND: Dominant stricture (DS) is a main cause of complication among patients with Primary Sclerosing Cholangitis (PSC). Endoscopic treatment options include dilation and plastic stenting, each with its own benefits and drawbacks. AIMS: The aim of the current study is to assess the safety and efficacy of fully-covered metal stent (FCMS) in these patients. METHODS: A retrospective study of PSC patients with refractory DS, defined as strictures resistance to conventional therapy (balloon dilatation, plastic biliary stent insertion or both) and who underwent FCMS insertion for 3 months were included. The primary outcome was defined as clinical and laboratory improvement, while secondary outcomes were DS resolution upon stent removal and cholangiographic DS recurrence at 12-months after FCMS extraction. RESULTS: Twenty patients were enrolled from January 2016 through January 2020. Improvement in weakness and pruritus were seen in 80% and 35%, 75% and 65%, 75% and 35% of patients at 1-3 and 6 months following FCMS removal, respectively. Similarly, consistent improvement in all liver enzymes and total bilirubin were seen in up to 6 month following stent removal. Only one patient (5%) needed premature FCMS removal due to cholangitis 1 week after stent placement and 2 cases (10%) of stent related pancreatitis were encountered. At 3-months all remaining stents were softly removed. Cholangiographic DS resolution was demonstrated in 13 patients (65%) after stent removal at 3-months, and DS recurred in 4 patients (4/13 = 30.7%) at 12-months following stent removal. Notably, only proximal biliary DS location showed a trend for DS recurrence (OR 28.6, P = 0.06). CONCLUSION: Temporary 3 months duration FCMS was feasible, safe and effective treatment option among patients with PSC related refractory DS.


Assuntos
Colangite Esclerosante , Colestase , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Colangite Esclerosante/complicações , Colangite Esclerosante/cirurgia , Colestase/etiologia , Constrição Patológica/etiologia , Constrição Patológica/cirurgia , Humanos , Fígado , Metais , Recidiva Local de Neoplasia/etiologia , Plásticos , Estudos Retrospectivos , Stents/efeitos adversos , Resultado do Tratamento
5.
Int Urogynecol J ; 33(10): 2859-2868, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-35039916

RESUMO

INTRODUCTION AND HYPOTHESIS: Fecal incontinence is a debilitating condition with a devastating impact on quality of life. Using a commercially available kinesiology band we developed an anal tape to be applied to the anus with the aim to determine its impact on symptom bother and quality of life. METHODS: Four-week prospective, self-controlled, pilot study of patients with FI. The primary outcome was improvement in any of the four domains (lifestyle, coping/behavior, depression/self-perception, embarrassment) evaluated by the "Fecal Incontinence Quality of Life Scale." Secondary outcomes included improvement in frequency of incontinence events and safety. Days 0-14 served as control period and days 15-28 as study period. Patients were asked to rate their satisfaction and willingness to use the device in the future using a 10-cm continuous visual analog scale. RESULTS: Twenty patients completed the study. Median age was 64 years; all patients were females. Significant improvements were observed in all domains of the Fecal Incontinence Quality of Life Scale from baseline to day 28 (p < 0.001 for all) and in three of four domains between day 15 and 28 (p < 0.04) but not between days 1 and 14. Five patients (25%) had a ≥ 50% improvement in incontinence events. Patients reported satisfaction and willingness to use the anal tape in the future. Other than mild difficulty to remove the anal tape, no adverse events were reported. CONCLUSIONS: In this small pilot study, the use of the anal tape was safe and effective. The primary outcome of significant improvement in quality of life was achieved ( ClinicalTrials.gov ID:NCT02989545). PUBLIC TRIAL REGISTRY: ClinicalTrials.gov identifier NCT02989545. https://clinicaltrials.gov/ct2/show/NCT02989545.


Assuntos
Incontinência Fecal , Canal Anal , Incontinência Fecal/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Estudos Prospectivos , Qualidade de Vida , Resultado do Tratamento
6.
Gastrointest Endosc ; 94(6): 1099-1109.e10, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34216598

RESUMO

BACKGROUND AND AIMS: Colorectal cancer is a leading cause of death. Colonoscopy is the criterion standard for detection and removal of precancerous lesions and has been shown to reduce mortality. The polyp miss rate during colonoscopies is 22% to 28%. DEEP DEtection of Elusive Polyps (DEEP2) is a new polyp detection system based on deep learning that alerts the operator in real time to the presence and location of polyps. The primary outcome was the performance of DEEP2 on the detection of elusive polyps. METHODS: The DEEP2 system was trained on 3611 hours of colonoscopy videos derived from 2 sources and was validated on a set comprising 1393 hours from a third unrelated source. Ground truth labeling was provided by offline gastroenterologist annotators who were able to watch the video in slow motion and pause and rewind as required. To assess applicability, stability, and user experience and to obtain some preliminary data on performance in a real-life scenario, a preliminary prospective clinical validation study was performed comprising 100 procedures. RESULTS: DEEP2 achieved a sensitivity of 97.1% at 4.6 false alarms per video for all polyps and of 88.5% and 84.9% for polyps in the field of view for less than 5 and 2 seconds, respectively. DEEP2 was able to detect polyps not seen by live real-time endoscopists or offline annotators in an average of .22 polyps per sequence. In the clinical validation study, the system detected an average of .89 additional polyps per procedure. No adverse events occurred. CONCLUSIONS: DEEP2 has a high sensitivity for polyp detection and was effective in increasing the detection of polyps both in colonoscopy videos and in real procedures with a low number of false alarms. (Clinical trial registration number: NCT04693078.).


Assuntos
Pólipos Adenomatosos , Pólipos do Colo , Neoplasias Colorretais , Inteligência Artificial , Pólipos do Colo/diagnóstico , Colonoscopia , Neoplasias Colorretais/diagnóstico , Humanos , Estudos Prospectivos
7.
Scand J Gastroenterol ; 56(3): 369-373, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33460351

RESUMO

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) has been identified as risk factor for several diseases; however, its association with post endoscopic retrograde cholangiopancreatography pancreatitis (PEP) has not been studied. AIMS: To assess whether NAFLD is a risk factor for the development of PEP. METHODS: We performed a retrospective multicenter study. All patients who underwent ERCP during 2013-2016 at either the Shaare Zedek Medical Center in Jerusalem or EMMS Nazareth hospital and who had a diagnosis of NAFLD by abdominal imaging were eligible for inclusion. Four hundred and one patients were included, among them, 38 (9.5%) were diagnosed with PEP according to clinical, laboratory and radiological criteria. RESULTS: In univariate analysis, the following risk factors were associated with increased risk for PEP; Fatty liver (OR 2.363, p = .01), elevated levels of aspartate transaminase (OR 1.008, p = .04), ALT (OR 0.979, p = .0007), alkaline phosphatase (OR 1.008, p = .01), gamma-glutamyl transferase (OR 1.014, p = .0005) and total bilirubin (OR 1.141, p = .005). In multivariate logistic regression analysis, only NAFLD showed statistically significant association with PEP (OR 3.224, 95% CI 1.548-6.713, p = .001) with receiver operator characteristics (ROC) area under the curve (AUC) of 0.8156. CONCLUSION: NAFLD was shown to be a risk factor for PEP. Therefore, we suggest considering prophylactic pancreatic stenting and/or NSAID's suppositories among these patients.


Assuntos
Hepatopatia Gordurosa não Alcoólica , Pancreatite , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Humanos , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Hepatopatia Gordurosa não Alcoólica/etiologia , Pâncreas , Pancreatite/epidemiologia , Pancreatite/etiologia , Estudos Retrospectivos , Fatores de Risco
8.
Dig Dis ; 39(5): 502-507, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33503640

RESUMO

BACKGROUND: The use of medical cannabis (MC) for inflammatory bowel diseases (IBDs) is expanding. Current evidence does not support the efficacy of MC for reducing inflammation in IBD patients. Even so, many gastroenterologists encounter the issue of recommending use of MC to IBD patients. METHODS: A Web-based survey was completed by 84 (34%) gastroenterologists in Israel. RESULTS: Out of 84 physicians whom completed the questionnaire, 59 (70%) were male, 34 (40%) were under age 50 years, 71 (85%) were adult gastroenterologists, and 53 (63%) work mainly in a hospital. Of them, 15, 41, and 44% of physicians think that MC is very effective, mildly effective, and not effective at all, respectively. Physicians will commonly, rarely, and never recommend MC in 31, 47, and 22%, respectively. Older physicians (above age 50 years) were significantly more likely to have a positive attitude towards MC in both questions. When presented with a clinical scenario of a patient in deep remission, requesting to increase the dose, 32% would increase, 49% would maintain, and only 18% would stop prescribing MC altogether; 48% of physicians did not know the recommended initial dose for MC. Only 2 (2.5%) physicians initiated the use of MC to all patients. Female gastroenterologists were significantly more likely to initiate MC, p = 0.048. CONCLUSION: The use of MC for IBD patients is commonly encountered. Completely different attitudes regarding this treatment were seen. Age above 50 years and female physicians generally had a more positive attitude towards the use of MC. Guidelines and clear recommendations are needed.


Assuntos
Gastroenterologistas , Doenças Inflamatórias Intestinais , Maconha Medicinal , Adulto , Atitude do Pessoal de Saúde , Feminino , Humanos , Doenças Inflamatórias Intestinais/tratamento farmacológico , Israel/epidemiologia , Masculino , Maconha Medicinal/uso terapêutico , Pessoa de Meia-Idade
9.
Age Ageing ; 50(5): 1840-1844, 2021 09 11.
Artigo em Inglês | MEDLINE | ID: mdl-34120168

RESUMO

BACKGROUND: invasive gastrointestinal (GI) procedures are increasingly performed on much older patients but data regarding oesophagogastroduodenoscopy (OGD) in this population are limited. We compared the indications, safety and benefits of OGD for nonagenarians compared to octogenarians. METHODS: an observational retrospective review of patients who underwent OGD between 2013 and 2018 at a gastroenterology institute in one large hospital. Patients aged 90 and above 'nonagenarians' were compared to those aged 80-89 'octogenarians'. RESULTS: 472 patients (231 nonagenarians and 241 octogenarians), median age of 91 for nonagenarians (201 aged 90-94, 30 aged 95 and older) and 82 (174 aged 80-84, 67 aged 85-89) for octogenarians. GI bleeding was a more common and dyspepsia, a less common, indication for nonagenarians compared to octogenarians (55 and 7%, versus 43 and 18%). Significant findings and need for endoscopic treatments were both more commonly found in nonagenarians compared to octogenarians (25 and 24% versus 15 and 8%, respectively). General anaesthesia was more commonly given to nonagenarians (35 versus 10%). Immediate complications and 30-day mortality rate were similar between the groups: (2.6% of nonagenarians versus 1.6% of octogenarians). Of 30 patients aged 95 and older, 13% had late adverse events, compared to 1% of the overall cohort. CONCLUSIONS: OGD appears safe in nonagenarians. Pathological findings and endoscopic interventions are more common. Decisions regarding OGD should not be based on age alone.


Assuntos
Endoscopia do Sistema Digestório , Fatores Etários , Idoso de 80 Anos ou mais , Estudos de Coortes , Humanos , Estudos Retrospectivos , Resultado do Tratamento
10.
World J Surg Oncol ; 19(1): 341, 2021 Dec 08.
Artigo em Inglês | MEDLINE | ID: mdl-34876136

RESUMO

BACKGROUND: Early detection of colorectal cancer (CRC) improves prognosis, yet many CRCs are diagnosed following symptoms. The aim of this study was to determine which CRC-related symptoms or signs can predict an advanced CRC in the pre-operative stage. METHODS: Retrospective analysis of 300 patients who underwent surgery for CRC between the years 2008 and 2019. Patients' symptoms prior to CRC diagnosis were documented. Primary endpoint was the association of signs or/and symptoms with CRC diagnosis at TNM stages of 2-4 (i.e., highly advanced), compared to TNM score of 0-1 (i.e., locally advanced). RESULTS: Three hundred patients, 91 with locally advanced and 209 with highly advanced CRC, were enrolled. There was a significant correlation between highly advanced CRC, compared to locally advanced, regarding tumor size (4.8 vs. 2.6 cm, p<0.001), presentation of any symptom prior to diagnosis (77% vs. 54%, p<0.001), anemia (46% vs. 29%, p=0.004), and severe anemia (17% vs. 4%, p=0.002). Mean hemoglobin was 12.2 ± 2.2 and 13.1 ± 1.8 in the highly advanced compared to locally advanced CRC, respectively, p<0.001. Anemia correlated with the T stage of the tumor: 21% of patients diagnosed at stages 0-1 had anemia, 39% at stage 2, 44% at stage 3, and 66% at stage 4 (p=0.001). CONCLUSIONS: Anemia is the only finding that correlates with highly advanced CRC, in the pre-operative stage. When CRC has been diagnosed, the presence of anemia, at any level, may be considered in determining prognosis at the pre-operative stage. Physicians should be aware that when anemia is present, the risk for highly advanced CRC increases, and therefore should pursue with CRC detection.


Assuntos
Anemia , Neoplasias Colorretais , Anemia/diagnóstico , Anemia/etiologia , Colonoscopia , Neoplasias Colorretais/complicações , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/cirurgia , Detecção Precoce de Câncer , Humanos , Estadiamento de Neoplasias , Prognóstico , Estudos Retrospectivos
11.
Scand J Gastroenterol ; 55(7): 819-823, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32568557

RESUMO

Introduction: Iron deficiency anemia (IDA) is a risk factor for gastrointestinal (GI) malignancies. Little is known regarding the correlation between the depth of anemia and the risk for GI malignancy. The aim of this study was to test the hypothesis that very low hemoglobin levels pose an additional risk compared to low hemoglobin levels.Methods: Patients 40-70 years old, presenting to the ER with IDA during years 2016-2017 were retrospectively analyzed. Comparison was performed between two groups, one with a very low hemoglobin level (below 8 g/dL) and the other a low hemoglobin level (between 8-10 g/dL).Results: 1020 patients were analyzed, and 107 fulfilled the inclusion criteria. Seventy-five patients (70%) were in the very low hemoglobin group and 21 patients (19.6%) were diagnosed with a new GI malignancy. Mean age was 56, 49 (45%) were females, and 68 (63%) underwent esophagogastroduodenoscopy (EGD) or/and colonoscopy during the index hospitalization. The median hemoglobin and MCV were 7.3 G/dL, and 73 fL, respectively. New malignancies were found in 15/75 (20%) and 6/32 (19%) of patients with very low and low hemoglobin levels, respectively (p = .88). GI malignancies were more commonly found in females compared to males, 14 (29%) vs. 7 (12%), p = .032, respectively. The right colon was the most common site for malignancy. Active GI bleeding was not a risk factor for GI malignancy.Conclusions: Very low hemoglobin levels and overt GI bleeding do not pose an additional risk factor for GI malignancy, compared to low hemoglobin levels and no overt GI bleeding.


Assuntos
Anemia Ferropriva/sangue , Anemia Ferropriva/epidemiologia , Neoplasias Gastrointestinais/epidemiologia , Hemoglobinas/análise , Adulto , Idoso , Anemia Ferropriva/complicações , Colonoscopia/efeitos adversos , Endoscopia do Sistema Digestório , Feminino , Hemorragia Gastrointestinal/complicações , Neoplasias Gastrointestinais/complicações , Humanos , Israel/epidemiologia , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estudos Retrospectivos
12.
Arch Gynecol Obstet ; 301(6): 1449-1454, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32377786

RESUMO

PURPOSE: Disease flare throughout gestation are not uncommon among women with inflammatory bowel diseases (IBD), and can substantially affect pregnancy outcomes. We aimed to evaluate the effect of prior pregnancy outcome on the risk of disease flare at subsequent pregnancy in women with IBD. METHODS: Women with IBD attending a multidisciplinary clinic for the preconception, antenatal and postnatal treatment were prospectively recruited during 2011-2018. RESULTS: Overall, 476 IBD women were followed during the study period. Of them, 69 (14.5%) had two pregnancies throughout follow-up period and constituted the study cohort. Among these 69 women, 48 (69.6%) had Crohn's disease and 21 (30.4%) ulcerative colitis. The median interpregnancy interval was 20 [11-32] months. Overall, 34 (49.3%) women experienced disease flare at the subsequent pregnancy. In multivariate analysis, active disease at conception (odds ratio [95% CI]: 25.65 (3.05, 25.52), P < 0.001) and history of disease flare at the previous pregnancy (odds ratio [95% CI]: 4.21 (1.10, 16.58), P < 0.001) were the only independent predictors of disease relapse in current gestation. Rates of hospitalization during pregnancy (14.7% vs. 0, P = 0.02) and preterm delivery (32.4% vs. 5.7%, P = 0.006) were higher, and neonatal birth weight was lower (median 3039 vs. 3300 g, P = 0.03), in those with disease flare as compared to those with maintained remission. CONCLUSION: History of disease relapse at previous gestation and periconception disease activity were found as important predictors of disease flare among IBD women. These data would facilitate adequate counseling and informed management decisions among reproductive-aged IBD women and their treating physicians.


Assuntos
Doenças Inflamatórias Intestinais/complicações , Complicações na Gravidez/etiologia , Adulto , Feminino , Humanos , Gravidez , Complicações na Gravidez/patologia , Resultado da Gravidez , Estudos Prospectivos , Recidiva , Exacerbação dos Sintomas
13.
Gastroenterology ; 154(5): 1334-1342.e4, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29277560

RESUMO

BACKGROUND & AIMS: Therapies for perianal fistulas in patients with Crohn's disease are often ineffective in producing long-term healing. We performed a randomized placebo-controlled trial to determine the long-term efficacy and safety of a single local administration of allogeneic expanded adipose-derived stem cells (Cx601) in patients with Crohn's disease and perianal fistulas. METHODS: We performed a double-blind study at 49 hospitals in Europe and Israel, comprising 212 patients with Crohn's disease and treatment-refractory, draining, complex perianal fistulas. Patients were randomly assigned (1:1) to groups given a single local injection of 120 million Cx601 cells or placebo (control), in addition to the standard of care. Efficacy endpoints evaluated in the modified intention-to-treat population (randomly assigned, treated, and with 1 or more post-baseline efficacy assessment) at week 52 included combined remission (closure of all treated external openings draining at baseline with absence of collections >2 cm, confirmed by magnetic resonance imaging) and clinical remission (absence of draining fistulas). RESULTS: The study's primary endpoint, at week 24, was previously reported (combined remission in 51.5% of patients given Cx601 vs 35.6% of controls, for a difference of 15.8 percentage points; 97.5% confidence interval [CI] 0.5-31.2; P = .021). At week 52, a significantly greater proportion of patients given Cx601 achieved combined remission (56.3%) vs controls (38.6%) (a difference of 17.7 percentage points; 95% CI 4.2-31.2; P = .010), and clinical remission (59.2% vs 41.6% of controls, for a difference of 17.6 percentage points; 95% CI 4.1-31.1; P = .013). Safety was maintained throughout week 52; adverse events occurred in 76.7% of patients in the Cx601 group and 72.5% of patients in the control group. CONCLUSION: In a phase 3 trial of patients with Crohn's disease and treatment-refractory complex perianal fistulas, we found Cx601 to be safe and effective in closing external openings, compared with placebo, after 1 year. ClinicalTrials.gov no: NCT01541579.


Assuntos
Tecido Adiposo/citologia , Doença de Crohn/complicações , Fístula Retal/cirurgia , Transplante de Células-Tronco , Adulto , Doença de Crohn/diagnóstico , Método Duplo-Cego , Europa (Continente) , Feminino , Humanos , Análise de Intenção de Tratamento , Israel , Imageamento por Ressonância Magnética , Masculino , Fístula Retal/diagnóstico por imagem , Fístula Retal/etiologia , Indução de Remissão , Fatores de Risco , Transplante de Células-Tronco/efeitos adversos , Fatores de Tempo , Transplante Homólogo , Resultado do Tratamento
14.
Am J Gastroenterol ; 114(7): 1172-1175, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30920987

RESUMO

OBJECTIVES: Despite encouraging data gathered in inflammatory bowel diseases (IBD) patients, Vedolizumabs' (VDZ) safety profile in pregnancy is not established. DESIGN: Data of 330 consecutive pregnancies with IBD was prospectively collected. RESULTS: Women with IBD were treated with: VDZ (n = 24), anti-tumor necrosis factors (n = 82) or conventional therapy (n = 224). Gravidity and parity were similar among the 3 groups. The VDZ group was comprised mostly of Crohn's disease patients who were all not naïve to biological treatment. They had significantly higher conception rates during active disease (P < 0.05), with fewer flares during pregnancy. DISCUSSION: Although further study is needed, VDZ appears of low risk during pregnancy.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Segurança do Paciente , Resultado da Gravidez , Fator de Necrose Tumoral alfa/uso terapêutico , Adulto , Anticorpos Monoclonais Humanizados/efeitos adversos , Estudos de Coortes , Doença de Crohn/diagnóstico , Doença de Crohn/tratamento farmacológico , Feminino , Fármacos Gastrointestinais/administração & dosagem , Fármacos Gastrointestinais/efeitos adversos , Humanos , Recém-Nascido , Doenças Inflamatórias Intestinais/diagnóstico , Gravidez , Gravidez de Alto Risco , Prognóstico , Estudos Prospectivos , Medição de Risco
15.
Dig Dis Sci ; 64(8): 2286-2290, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30815823

RESUMO

INTRODUCTION: Thiopurine exposure throughout pregnancy in patients with inflammatory bowel diseases (IBD) is common and teratogenically safe. Late consequences of in utero exposure to thiopurines and its metabolite, 6-thioguanine nucleotides (6-TGN), such as neonatal and infant anemia are still disputed. AIM: To evaluate whether 6-TGN exposure during pregnancy influences anemia in infants at 1 year of life. METHODS: A comparative observational study was performed between 2009 and 2015 at a multidisciplinary IBD clinic dedicated to pregnant women. The hemoglobin level and signs of anemia between 9 and 15 months after birth of infants born to women exposed to thiopurines throughout the entire pregnancy was compared to infants of women with no thiopurine exposure during pregnancy. RESULTS: Altogether, 34 patients, 21 in the study group and 13 in the control group, were included. The median duration of maternal thiopurine exposure prior to pregnancy was 24 months (range 12-72 months), and median dosage was 100 mg (range 50-175 mg). Maternal IBD activity, infants' iron supplementation, and iron deficiency diagnoses were similar between both groups. The infants' mean hemoglobin level (gr/dL) in the thiopurine-exposed women versus the control group was 11.48 ± 0.8 versus 11.54 ± 0.6, respectively, p = 0.81. The composite risk of any sign of infant anemia was numerically higher in the thiopurine-exposed women, 10 (47%), compared to non-exposed women, 3 (23%), p = 0.17. The mean corpuscular volume, red cell distribution width, white blood cell, and platelet counts were similar among groups. CONCLUSIONS: Thiopurine therapy during pregnancy in women with IBD is safe for long-term neonatal outcomes; still large-scale confirmatory studies are required.


Assuntos
Anemia/induzido quimicamente , Imunossupressores/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Mercaptopurina/uso terapêutico , Complicações na Gravidez/tratamento farmacológico , Adulto , Anemia Neonatal/induzido quimicamente , Feminino , Humanos , Imunossupressores/administração & dosagem , Lactente , Recém-Nascido , Mercaptopurina/administração & dosagem , Gravidez , Resultado da Gravidez
16.
Gastroenterology ; 152(8): 1876-1880.e1, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-28242209

RESUMO

Hereditary mixed polyposis syndrome is a rare colon cancer predisposition syndrome caused by a duplication of a noncoding sequence near the gremlin 1, DAN family BMP antagonist gene (GREM1) originally described in Ashkenazi Jews. Few families with GREM1 duplications have been described, so there are many questions about detection and management. We report 4 extended families with the duplication near GREM1 previously found in Ashkenazi Jews; 3 families were identified at cancer genetic clinics in Israel and 1 family was identified in a cohort of patients with familial colorectal cancer. Their clinical features include extracolonic tumors, onset of polyps in adolescence, and rapid progression of some polyps to advanced adenomas. One family met diagnostic criteria for Lynch syndrome. Expansion of the hereditary mixed polyposis syndrome phenotype can inform surveillance strategies for carriers of GREM1 duplications.


Assuntos
Polipose Adenomatosa do Colo/diagnóstico , Polipose Adenomatosa do Colo/genética , Biomarcadores Tumorais/genética , Colo/patologia , Neoplasias Colorretais Hereditárias sem Polipose/diagnóstico , Neoplasias Colorretais Hereditárias sem Polipose/genética , Detecção Precoce de Câncer/métodos , Duplicação Gênica , Peptídeos e Proteínas de Sinalização Intercelular/genética , Polipose Adenomatosa do Colo/etnologia , Polipose Adenomatosa do Colo/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Colonoscopia , Neoplasias Colorretais Hereditárias sem Polipose/etnologia , Neoplasias Colorretais Hereditárias sem Polipose/patologia , Análise Mutacional de DNA , Progressão da Doença , Feminino , Predisposição Genética para Doença , Hereditariedade , Humanos , Israel , Judeus/genética , Masculino , Pessoa de Meia-Idade , Técnicas de Diagnóstico Molecular , Mutação , Linhagem , Fenótipo , Fatores de Tempo , Adulto Jovem
17.
Dig Dis Sci ; 63(11): 2992-2997, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30027514

RESUMO

BACKGROUND: Poor sleep quality is associated with adverse health consequences. Sleep disturbances can impact the immune function and inflammatory processes. Little is known about sleep disturbances in patients with inflammatory bowel disease (IBD), while not in flare, i.e., inactive. AIMS: To prospectively explore the sleep quality of patients with an inactive IBD. METHODS: This pilot study included 36 consecutive patients with IBD and 27 healthy volunteers. All IBD patients had an inactive disease. Participants underwent an overnight ambulatory polysomnography. Data on disease duration, medications, complications, and treatment were collected from the medical records. RESULTS: The mean age of the IBD and the control groups was 39 ± 15 and 34.6 ± 9.6 years. A significantly less rapid eye movement (REM) sleep was noted in the IBD group vs. control (23.7 vs. 27.8%, p = 0.047); light sleep percentage and REM latency were also longer in the IBD group. Moreover, oxygen desaturation below 90% was more common in the IBD group. All other sleep parameters including respiratory disturbance index, apnea-hypopnea index, number of wakes, sleep latency, and snoring strength were similar in both groups. CONCLUSIONS: Inactive IBD is associated with sleep disturbances. A larger prospective study should be conducted to confirm these findings.


Assuntos
Doenças Inflamatórias Intestinais/complicações , Transtornos do Sono-Vigília/complicações , Adulto , Estudos de Casos e Controles , Feminino , Humanos , Doenças Inflamatórias Intestinais/fisiopatologia , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Estudos Prospectivos , Sono
18.
Dig Dis Sci ; 63(1): 198-203, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29134299

RESUMO

BACKGROUND: Fecal microbiota transplantation (FMT) is a new technique recently introduced to treat recurrent Clostridium difficile infection (CDI). Little is known about the efficacy and risks of FMT in elderly and ill patients. AIM: To investigate FMT efficacy in ill and elderly patients compared to conventional treatment. METHODS: The study comprised two groups of patients between 2012 and 2016 with recurrent CDI at two medical centers in Israel. The study group received FMT and the controls conventional therapy. The primary end points were CDI recurrence, length of hospitalization, and short-term survival. RESULTS: Thirty-four patients altogether, (21 females, mean age 82 years) participated, 11 received FMT and 23 controls. Demographics and clinical characteristics were similar between the two groups. Comorbidity indexes, i.e., Charlson index was high in both groups. In the FMT group, 10/11 (90%) patients showed clinical improvement 3 days after initiating treatment compared to 9/23 (39%) in the control group, p = 0.02. Survival at 2 months did not differ between the groups (FMT 54%, Control 50%, p = 0.816), but mean survival in the FMT group was higher than in the control (12 vs. 4 months, respectively, p = 0.015). Two significant adverse events from the FMT group included suspected aspirations, both occurring during gastroscopy route of administration. CONCLUSIONS: FMT is effective for elderly and very ill patients. Safety is a concern, but is rare even in patients with much comorbidity. Colonoscopy may be the preferred route of FMT infusion.


Assuntos
Clostridioides difficile , Infecções por Clostridium/terapia , Transplante de Microbiota Fecal/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
19.
Dig Dis Sci ; 63(9): 2485, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29704140

RESUMO

The original version of the article unfortunately contained tagging error in first and family name of authors Ariella Bar-Gil Shitrit and Ami Ben Ya'acov. This has been corrected with this erratum.

20.
Dig Dis Sci ; 63(7): 1774-1781, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29626275

RESUMO

BACKGROUND: Inflammatory bowel disease affects women during their reproductive years and thus pregnancy outcomes. IBD MOM is a multidisciplinary, single-center clinic established to benefit women with IBD and their neonates. AIM: The aim of this study was to evaluate the perinatal outcomes of the IBD MOM clinic patients compared to patients who attended antenatal and gastrointestinal disease community clinics (IBD CC). METHODS: This single-center, prospective study was conducted from 2011 to 2015. The primary outcome was cesarean delivery; secondary was adverse perinatal outcomes. In parallel, a new pregnancy-oriented, disease severity score was evaluated for its association with perinatal risk (score low = 0 to severe = 5). RESULTS: We identified 90 women in the IBD MOM clinic and 206 in the IBD CC. Maternal age, smoking habits, pregnancy complications, and type of IBD (CD/UC) were similar between groups. Rates of labor induction and birth weight were also similar between IBD MOM and IBD GI. The IBD MOM overall preterm delivery (PTD) rate (< 37 weeks) was significantly higher 18.9 versus 9.7% (P = 0.028). The IBD MOM group had a significantly higher IBD MOM disease severity score that correlated with a higher rate of PTD. The overall IBD MOM score and scores > 3 were significantly associated with PTD risk in both groups (P = 0.013 and P = 0.004, respectively). CONCLUSION: Women with moderate and severe IBD who attended a multidisciplinary clinic may benefit from this unique center. Healthcare planning policies can assume that costly, multidisciplinary clinics for women with IBD should be reserved for those with moderate and severe disease.


Assuntos
Instituições de Assistência Ambulatorial , Doenças Inflamatórias Intestinais/terapia , Parto , Cuidado Pré-Natal , Adulto , Peso ao Nascer , Estudos de Casos e Controles , Cesárea , Feminino , Idade Gestacional , Humanos , Recém-Nascido de Baixo Peso , Recém-Nascido , Doenças Inflamatórias Intestinais/complicações , Doenças Inflamatórias Intestinais/diagnóstico , Doenças Inflamatórias Intestinais/fisiopatologia , Israel , Trabalho de Parto Induzido , Nascido Vivo , Gravidez , Nascimento Prematuro/etiologia , Estudos Prospectivos , Índice de Gravidade de Doença , Resultado do Tratamento , Adulto Jovem
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