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BACKGROUND AND AIMS: Telemonitoring is increasingly used in the management of IBD patients. We investigated the agreement between patients and physicians on scores of disease activity and burden. METHODS: Consecutive outpatients at one IBD clinic were recruited between February and December 2021. Enrolled patients completed a questionnaire for disease activity (Harvey-Bradshaw Index [HBI] for Crohn's disease or Simple Clinical Colitis Activity Index [SCCAI] for ulcerative colitis) and a test of disease burden (Pictorial Representation of Illness and Self Measure [PRISM]). They did the tests within 5 days of an outpatient visit, working independently on IBD Tool, a new web-based telemonitoring application. Concomitantly, the senior and junior physicians who examined them completed the same tests. The agreement was tested for every pair of scores. RESULTS: Five hundred and sixty patients (289 Crohn's disease; 271 ulcerative colitis) completed disease questionnaires on IBD Tool (in total, 742 times). By Spearman's correlation, the agreement was substantial both for HBI (rho 0.685-0.837) and SCCAI (rho 0.694-0.888) for comparisons between patients, junior and senior physicians. The agreement was moderate-to-substantial for PRISM (rho 0.406-0.725) for the same comparisons. The correlation between disease activity (HBI/SCCAI) and PRISM scores was substantial for senior (rho 0.757-0.788) or junior (rho 0.746-0.753) physicians and moderate for patients (rho 0.458-0.486). The median PRISM score difference was 2.3-1.6 points lower between patients and senior-junior physicians. CONCLUSION: Agreement between IBD patients and physicians was substantial for disease activity and moderate for disease impact. The inclusion of disease burden scoring in telemonitoring platforms provides important information for the management of IBD patients.Study highlightsWhat IS knownâ¢Continuous response to treatments and patient-reported outcomes became an essential goal for IBD patient management.â¢The use of tele-monitoring and eHealth technologies allows for regular disease assessments and for managing more efficiently IBD patients; disease questionnaires and tests are key to support eHealth tools.What is new hereâ¢Agreement between IBD patients and physicians was substantial for disease activity and moderate for disease burden, while agreement among junior and senior physicians was substantial for both.â¢PRISM performs as well for ulcerative colitis as for Crohn's patients.â¢The inclusion of disease burden tests might add to eHealth platforms valuable information, complemental to disease activity questionnaires.
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Colite Ulcerativa , Doença de Crohn , Doenças Inflamatórias Intestinais , Médicos , Humanos , Doença de Crohn/diagnóstico , Colite Ulcerativa/diagnóstico , Doenças Inflamatórias Intestinais/diagnóstico , Índice de Gravidade de Doença , Inquéritos e QuestionáriosRESUMO
BACKGROUND: The SARS-CoV-2 outbreak early in 2020 overwhelmed the Italian national health system, and hospitals were considered places at high risk of spreading the infection. We explored specific antibody seroprevalence of all employees at a single hospital in the epicentre of the outbreak, to identify areas of risk in nosocomial setting and to evaluate the usefulness of antibody testing. AIMS: Aim of this study was to explore SARS-CoV-2 seroprevalence in a single hospital workers cohort. METHODS: All hospital workers were invited to fill in a questionnaire and undergo a blood test for SARS-CoV-2 IgG, using two commercial tests (DiaSorin and Abbott). Seropositivity was determined overall and according to demographic and occupations characteristics, for both tests singly and combined. RESULTS: The study enrolled 1562 hospital workers (95% of the eligible population). Overall, 153 (9.8%) participants were positive for SARS-CoV-2 IgG on DiaSorin test, and 150 (9.6%) were positive on Abbott test; both tests were positive in 123 (7.9%) cases and at least one was positive in 180 (11.5%) cases. Factors associated with SARS-CoV-2 seropositivity included: being a smoker, working in emergency or medicine departments, being a healthcare practitioner, self-reporting a relative with COVID-19 or symptoms suggestive of COVID-19, and having undergone a nasopharyngeal swab test. The tests were accurate in discriminating infected cases, with an area under the receiver operating characteristic curve of 0.867 using manufacturer-suggested cut-offs and 0.929 using optimised cut-offs. For discriminating symptomatic subjects, this value was 0.915 using optimised cut-offs. CONCLUSIONS: Seroprevalence for SARS-CoV-2 in this population of hospital workers was overall about 10%, with an excess prevalence in roles and departments associated with contacts with COVID-19 patients.
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COVID-19 , SARS-CoV-2 , Anticorpos Antivirais , Pessoal de Saúde , Hospitais , Humanos , Itália/epidemiologia , Fatores de Risco , Estudos SoroepidemiológicosRESUMO
The difficulties involved in detecting and enumerating Mycobacterium avium subsp. paratuberculosis (MAP) as a pathogen potentially involved in Crohn's disease (CD) are well known. This study aimed to improve this situation through the application of multiple laboratory diagnostic tests to detect and isolate this bacterium from different specimens collected from CD-patients and non-CD subjects as controls. A total of 120 samples (terminal ileum and colon biopsies, blood and stool) were obtained from 19 CD-patients and from 11 individuals who did not have a clinicopathological diagnosis of CD (non-CD controls) attending for ileocolonoscopy. All samples were processed by staining techniques, culture on both solid and liquid media, and Insertion Sequence 900/F57 real-time PCR. The MAP frequency in CD-patients was found in a significantly greater proportion than in non-CD subjects; the most positive samples were biopsies from CD-patients tested by real-time PCR. MAP detection in biopsies, and in the other samples, by applying multiple and validated laboratory diagnostic tests, could be a marker of active infection, supporting MAP involvement in CD.
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Doença de Crohn/microbiologia , Mycobacterium avium subsp. paratuberculosis/isolamento & purificação , Paratuberculose/microbiologia , Adulto , Idoso , Doença de Crohn/diagnóstico , DNA Bacteriano/genética , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Mycobacterium avium subsp. paratuberculosis/genética , Paratuberculose/diagnóstico , Reação em Cadeia da Polimerase em Tempo Real , Adulto JovemRESUMO
Endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) are both crucial for the endoscopic management of biliopancreatic diseases: the combination of their diagnostic and therapeutic potential is useful in many clinical scenarios, such as indeterminate biliary stenosis, biliary stones, chronic pancreatitis and biliary and pancreatic malignancies. This natural and evident convergence between EUS and ERCP, which by 2006 we were calling the "Endoscopic ultrasonography retrograde colangiopancreatography (EURCP) concept", has become a hot topic in the last years, together with the implementation of the therapeutic possibilities of EUS (from EUS-guided necrosectomy to gastro-entero anastomoses) and with the return of ERCP to its original diagnostic purpose thanks to ancillary techniques (extraductal ultrasound (EDUS), intraductal ultrasound (IDUS), cholangiopancreatoscopy with biopsies and probe-based confocal laser endomicroscopy (pCLE)). In this literary review, we retraced the recent history of EUS and ERCP, reported examples of the clinical applicability of the EURCP concept and explored the option of performing the two procedures in only one endoscopic session, with its positive implications for the patient, the endoscopist and the health care system. In the last few years, we also evaluated the possibility of combining EUS and ERCP into a single endoscopic instrument in a single step, but certain obstacles surrounding this approach remain.
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Emergency subtotal colectomy is the standard treatment for acute severe ulcerative colitis (ASUC) unresponsive to medical treatment. No guidelines are available about surgical technique. The aim of the current survey was to identify the attitudes of Inflammatory Bowel Disease (IBD) surgeons concerning colectomy in patients with ASUC by means of a nationwide survey, with specific focus on intraoperative technical details. A survey was developed with focus on number of procedures performed, approach to vascular ligation, technique of bowel dissection, treatment of the omentum and of the rectal stump. Twenty Centres completed the survey. Seventy percent of responders started the colectomy laparoscopically. No significant differences were observed about vessels and mesocolic dissection as well as on the choice of the starting colon side and management of the omentum. Ileocolic vessels were ligated distally by 70% and at the origin by 30% and those who transect mesenteric vessels distally are significatively more likely to perform the dissection from lateral to medial and to cut the middle colic vessels distally and 100% of the ones linking left vessels at mesenteric axis transect middle colic vessels at the origin. No differences were observed in the treatment of rectal stump; however, all surgeons who performed a transrectal drainage (45%) left the rectal stump intraperitoneal (p < 0.05). No consensus exists about the technique of dissection, vascular ligation, treatment of the omentum and management of rectal stump. Further studies are needed to evaluate the impact of the different surgical techniques on patients' outcomes.
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Cólica , Colite Ulcerativa , Cirurgia Colorretal , Mesocolo , Colectomia/métodos , Cólica/cirurgia , Colite Ulcerativa/cirurgia , Humanos , Mesocolo/cirurgiaRESUMO
Aortoesophageal fistula is rare but fatal if untreated. Open thoracic surgery is associated with high operative mortality and morbidity. We report a case of a 77-year-old man who, treated with thoracic endovascular aortic repair (TEVAR) for descending thoracic aneurysm in another center, after an acute episode of hematemesis and melena was referred to our center. The total body computed tomography scan showed the presence of reperfusion of the descending thoracic aneurysm sac (8.8 cm in diameter) in the proximal and distal TEVAR landing zone (endoleak type I) without clear signs of fistulous tract with the esophageal lumen. The patient underwent new TEVAR inside previous implantation with proximal landing very close to left subclavian artery and distal landing just above celiac trunk. For the presence of a tracheoesophageal fistula, an esophageal endoprosthesis was implanted few days later, and a jejunostomy was performed. At 30 days, patient was in good general condition, but he died at 3 months' follow-up. Aortoesophageal fistula is a rare and usually fatal condition; early recognition and TEVAR treatment prevent immediate exsanguination in patients, but after deployment of the endograft, most patients are at risk for infectious complications. Cessation of bleeding and restoration of circulation is of paramount urgency, but infectious diseases and esophageal repair remain open problems.
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Aneurisma da Aorta Torácica/cirurgia , Doenças da Aorta/cirurgia , Implante de Prótese Vascular/efeitos adversos , Erros de Diagnóstico , Procedimentos Endovasculares , Fístula Esofágica/cirurgia , Neoplasias Esofágicas/diagnóstico , Fístula Traqueoesofágica/cirurgia , Fístula Vascular/cirurgia , Idoso , Doenças da Aorta/diagnóstico , Doenças da Aorta/etiologia , Aortografia/métodos , Procedimentos Endovasculares/instrumentação , Fístula Esofágica/diagnóstico , Fístula Esofágica/etiologia , Evolução Fatal , Humanos , Jejunostomia , Masculino , Desenho de Prótese , Reoperação , Tomografia Computadorizada por Raios X , Fístula Traqueoesofágica/diagnóstico , Fístula Traqueoesofágica/etiologia , Resultado do Tratamento , Fístula Vascular/diagnóstico , Fístula Vascular/etiologiaRESUMO
Intestinal involvement in ulcerative colitis is generally limited to the colon and rectum. We describe a life-threatening case of ulcerative enteritis occurring after colectomy. Other 53 similar cases are reported in the literature. The aim of this narrative review was to focus on ulcerative enteritis characteristics and diagnostic workup. A 25-year-old boy affected by ulcerative colitis underwent a total colectomy in an urgent setting for septic shock. Postoperative course was characterized by elevated ileostomy output, raised up to 10 L/day. Critical clinical conditions required resuscitation therapy. After exclusion of surgical complications, intestinal infections, and histologic specimen revision, the patient underwent endoscopic examination. Ileal biopsies revealed ileal localization of ulcerative colitis. Steroid treatment was finally effective. After literature revision, we classified all cases of ulcerative enteritis in three groups, according to intestinal involvement pattern and timing of clinical manifestation after operation. Out of 54 cases, 18 occurred within 1 month since colectomy (early ileitis), 10 later on (late ileitis) and 26 do not involve ileus (nonileitis). Clinical manifestation is generally severe in the first group and mild and chronic in the others. Differential diagnoses of ulcerative enteritis are represented by infectious, immunological, toxic, and ischemic disorders. Those conditions excluded, ulcerative enteritis can be easily detected by endoscopic biopsies and treated with immunosuppressive agents. Long term surveillance seems important since recurrences are described. In conclusion, clinicians should suspect ulcerative enteritis in all patients with previous colectomy history that develop unexplained gastrointestinal syndromes, in order to avoid therapeutic delay.
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Colite Ulcerativa , Enterite , Adulto , Colectomia , Colite Ulcerativa/diagnóstico , Colite Ulcerativa/cirurgia , Enterite/diagnóstico , Enterite/etiologia , Humanos , Ileostomia/efeitos adversos , Masculino , Complicações Pós-Operatórias , Reto/cirurgiaRESUMO
BACKGROUND AND AIMS: Post-surgical recurrence of Crohn's disease (CD) after ileocolonic resection is common. Early identification of features associated with recurrence is a standard procedure of postoperative management, but the prognostic role of such features when detected at later time points is unclear. We compared the predictivity for Crohn's disease recurrence of common clinical-instrumental variables when assessed early (<12 months) or late (>36 months) after surgery. METHODS: This retrospective study considered CD patients who had ileocolonic resection and were followed for a median of 7.6 years. Clinical characteristics, post-surgical therapy, endoscopy recurrence (Rutgeerts' score ≥i2) and ultrasound features were compared between subgroups who had a early or late post-surgical assessment. Univariate and multivariate analyses were done to identify variables associated with recurrence (clinical and surgical). RESULTS: Of 201 patients, 70 (32%) had a early and 39 (19%) had a late post-surgical assessment. The Early and Late subgroups had similar clinical characteristics. Overall, clinical relapse was observed in 131 patients (66%), surgical relapse in 31 (16%), endoscopic recurrence in 149 (75%) and ultrasonographic recurrence in 132 (66%), without significant differences in frequencies between subgroups. By Cox proportional hazard regression, endoscopic recurrence was a significant predictor of clinical recurrence overall (HR=2.31, Pâ¯=â¯0.002) and in the Early (HR=3.85, Pâ¯=â¯0.002) but not Late subgroup. DISCUSSION: The most informative postoperative CD assessment is the one done within the first year of surgery. Later endoscopic evaluations have no prognostic value and should be done only for clinical needs or for research purposes.
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Colectomia , Colonoscopia/estatística & dados numéricos , Doença de Crohn/diagnóstico , Fatores de Tempo , Ultrassonografia/estatística & dados numéricos , Adolescente , Adulto , Colo/cirurgia , Doença de Crohn/cirurgia , Feminino , Humanos , Íleo/cirurgia , Masculino , Período Pós-Operatório , Valor Preditivo dos Testes , Prognóstico , Recidiva , Estudos Retrospectivos , Medição de Risco , Adulto JovemRESUMO
Background and study aims COVID-19 has dramatically impacted endoscopy practice because upper endoscopy procedures can be aerosol-generating. Most elective procedures have been rescheduled. Endoscopic retrograde cholangiopancreatography (ERCP) is frequently performed in emergency or urgent settings in which rescheduling is not possible. We evaluated the impact of the COVID-19 pandemic on ERCP in Italy during the SARS-CoV-2 lockdown, in areas with high incidence of COVID-19. Patients and methods We performed a retrospective survey of centers performing ERCP in high COVID-19 prevalence areas in Italy to collect information regarding clinical data from patients undergoing ERCP, staff, case-volume and organization of endoscopy units from March 8, 2020 to April 30, 2020. Results We collected data from 31 centers and 804 patients. All centers adopted a triage and/or screening protocol for SARS-CoV-2 and performed follow-up of patients 2 weeks after the procedure. ERCP case-volume was reduced by 44.1â% compared to the respective 2019 timeframe. Of the 804 patients undergoing ERCP, 22 (2.7â%) were positive for COVID-19.âAdverse events occurred at a similar rate to previously published data. Of the patients, endoscopists, and nurses, 1.6â%, 11.7â%, and 4.9â%, respectively, tested positive for SARS-CoV-2âat follow up.âOnly 38.7â% of centers had access to a negative-pressure room for ERCP. Conclusion The case-volume reduction for ERCP during lockdown was lower than for other gastrointestinal endoscopy procedures. No definitive conclusions can be drawn about the percentage of SARS-CoV-2-positive patients and healthcare workers observed after ERCP. Appropriate triage and screening of patients and adherence to society recommendations are paramount.
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BACKGROUND: Chronic atrophic gastritis (CAG) is a precursor of the intestinal type of gastric cancer, the second leading cause of cancer-related death worldwide. GastroPanel is a recently marketed serological kit for the non-invasive diagnosis of CAG, defined by some authors "even more reliable than biopsy histology". The goal of this study was 1) to evaluate the agreement between the serum gastric profile provided by GastroPanel (PGI, PGII, G-17, AbHp) and histology over CAG diagnosis, and 2) to evaluate the prevalence of CAG by means of GastroPanel in a Northern Italian dyspeptic population. METHODS: Basal blood samples for GastroPanel parameters evaluation (Biohit Plc, Finland) were collected after an overnight fast from 1387 dyspeptic patients (age range: 18-80 years; F 704). Gastroscopy with two biopsies each of the antrum and corpus was offered to a group of the first 400 consecutive patients (age 18-80 years, F 214) to compare the results of histology and GastroPanel in CAG. RESULTS: Agreement between GastroPanel and histology for corpus-prevalent CAG was 94%, with a sensitivity and specificity of 80% and 96%, respectively. In our series of 1387 dyspeptic patients, the prevalence of corpus-prevalent CAG, of antral-prevalent CAG and of multifocal CAG (antrum+ corpus) was 10.7%, 3.6% and 2.4%, respectively. Out of the 34 patients with multifocal atrophic gastritis, 12% were under 30 years of age. CONCLUSIONS: GastroPanel is a reliable non-invasive test for diagnosis of CAG and deserves consideration for current use in clinical practice as a valuable diagnostic tool.
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Coleta de Dados , Dispepsia/complicações , Gastrite Atrófica/complicações , Gastrite Atrófica/epidemiologia , Testes Sorológicos/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Endoscopia do Sistema Digestório , Feminino , Gastrite Atrófica/diagnóstico , Gastrite Atrófica/patologia , Trato Gastrointestinal/imunologia , Trato Gastrointestinal/microbiologia , Helicobacter pylori/imunologia , Helicobacter pylori/fisiologia , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Sensibilidade e Especificidade , Adulto JovemRESUMO
BACKGROUND: Enhanced Recovery After Surgery (ERAS) offers many benefits for patients with colorectal cancer. However, its application to patients with Crohn's disease (CD) is questioned. AIM: The aim of this propensity-matched study was to validate the results of ERAS protocol on CD patients. METHODS: Patients undergoing ileocolic resection for primary or relapsed CD from 2007 to 2018 were retrospectively analyzed and propensity-matched into two equal groups (ERAS vs standard of care). Demographic characteristics, length of stay, bowel function, oral intake, and perioperative morbidity were analyzed. RESULTS: Ninety four out of 299 patients were selected for analysis. No significant difference was observed for age, gender, American Society of Anesthesiologists score, body mass index, previous surgery and therapy, operative time and laparoscopy. The median length of stay in ERAS and non-ERAS groups was 6 and 8 days (pâ¯<â¯0.001). Median postoperative days of first bowel movement and solid oral intake were day 1 and day 2 pâ¯<â¯0,001, and day 2 and day 4.5 pâ¯<â¯0,001 in ERAS and non-ERAS group, respectively. No statistically differences in other postoperative outcomes were shown. CONCLUSIONS: ERAS implementation showed decreased length of stay, faster bowel function restoration and earlier solid oral intake in patients who underwent laparoscopic or open ileocolic resection for primary or relapsing CD.
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Doença de Crohn/cirurgia , Recuperação Pós-Cirúrgica Melhorada/normas , Tempo de Internação/estatística & dados numéricos , Adulto , Protocolos Clínicos , Colectomia/métodos , Ingestão de Alimentos , Feminino , Humanos , Laparoscopia/métodos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Período Pós-Operatório , Pontuação de Propensão , Recuperação de Função Fisiológica , Estudos RetrospectivosRESUMO
OBJECTIVE: Abdominal bowel ultrasound (US) is widely used in the management of Crohn's disease (CD). The aim of this study was to evaluate the prognostic role of bowel-wall US morphology on the short-term risk of surgery. MATERIAL AND METHODS: The 147 CD patients recruited in a case-control study comprised 49 cases operated on within 30 days after US examination and 98 matched non-operated controls. Clinical and US characteristics were analysed. Bowel-wall thickness was recorded, bowel-wall patterns were grouped into five types, but for final analysis they were grouped as "preserved" or "disrupted stratification". RESULTS: Wall thickness and US patterns were significantly different between cases and controls (p<0.0001). A wall thickness >4.5 mm was observed in 45/49 cases and 47/98 controls (OR = 12.21), while "disrupted stratification" was observed in 34/49 cases and 12/98 controls (OR = 16.24). Among the clinical and US characteristics recorded, only 4 US variables were independently associated with surgery (pattern, thickness, presence of fistulae/abscesses and stenoses) and considered for the US score=(2.5*US pattern)+(1.5*Bowel thickness)+(3*Presence of fistulae/abscesses)+(1.5*Presence of stenoses). Based on this score, up to 84% of patients were correctly classified according to actual status (operated/non-operated). CONCLUSIONS: Although it needs further prospective validation, the score we propose seems to be a reliable prognostic marker for the short-term risk of surgery in CD. In particular, the score points out those patients with an impending risk of surgery who need careful and frequent control in order to decide on the right time for surgery.
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Doença de Crohn/diagnóstico por imagem , Doença de Crohn/cirurgia , Intestinos/diagnóstico por imagem , Ultrassonografia Doppler/métodos , Adulto , Análise de Variância , Área Sob a Curva , Estudos de Casos e Controles , Colectomia/métodos , Colectomia/estatística & dados numéricos , Doença de Crohn/patologia , Progressão da Doença , Feminino , Seguimentos , Humanos , Imuno-Histoquímica , Intestinos/patologia , Modelos Logísticos , Masculino , Razão de Chances , Valor Preditivo dos Testes , Probabilidade , Recidiva , Medição de Risco , Sensibilidade e Especificidade , Índice de Gravidade de DoençaRESUMO
Percutaneous ultrasonography (perc-US) and magnetic resonance enterography (e-MR) are the present standards for staging patients with Crohn's disease (CD). However, intraoperative data still have some discrepancies with preoperative ones. The contribution of intraoperative ultrasonography (IOUS) has never been evaluated. Sixty-five consecutive patients scheduled for ileal/colonic resection for CD between 2010 and 2014 were prospectively enrolled. All patients had perc-US, e-MR and IOUS. Data from different imaging modalities were compared. The reference standard was the final pathology. Surgery was scheduled because of intestinal obstruction (n = 31 patients), inflammatory mass (n = 21), fistula (n = 10), or abdominal pain/sepsis (n = 3). Fourteen (21.5%) patients had a major discrepancy between preoperative and intraoperative data that required a modification of the surgical planning (five additional ileal lesions, three unknown ileo-sigmoid fistulas, and six not confirmed CD sites). IOUS correctly staged CD in all but one patients (missed ileo-colonic fistula). Pathology data differed from Perc-US data in 13 (20%) patients, from e-MR data in 14 (21.5%), and from IOUS data in one (1.5%). The sensitivity of Perc-US, e-MR and IOUS was: for the identification of CD sites 84.2%, 86.1%, and 100%; for the identification of stenoses 86.8%, 86.8%, and 100%; for the identification of fistulas 75.0%, 81.3%, and 93.8%, respectively. IOUS contributed to the surgical planning in 8 (12.3%) patients. IOUS is a safe, feasible and easy-to-perform procedure that optimizes staging of CD and, in some patients, helps to better define the treatment strategy. It could be helpful to face complex disease presentations on the basis of objective and reproducible data.
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Doença de Crohn/diagnóstico por imagem , Doença de Crohn/cirurgia , Ultrassonografia/métodos , Dor Abdominal/diagnóstico por imagem , Dor Abdominal/etiologia , Dor Abdominal/cirurgia , Adolescente , Adulto , Idoso , Doença de Crohn/complicações , Feminino , Humanos , Doenças Inflamatórias Intestinais/diagnóstico por imagem , Doenças Inflamatórias Intestinais/etiologia , Doenças Inflamatórias Intestinais/cirurgia , Fístula Intestinal/diagnóstico por imagem , Fístula Intestinal/etiologia , Fístula Intestinal/cirurgia , Obstrução Intestinal/etiologia , Obstrução Intestinal/cirurgia , Período Intraoperatório , Masculino , Pessoa de Meia-Idade , Adulto JovemRESUMO
BACKGROUND: Inflammatory bowel disease is treated with anti-TNF agents such as infliximab and its biosimilars, but use of biosimilars is limited due to perceived risks of adverse events. AIM: To explore safety and effectiveness of switching from the infliximab originator to a first biosimilar. PATIENTS AND METHODS: Clinical and biological outcomes were compared between 53 patients who switched from the infliximab originator to the biosimilar CT-P13 (Switched group) and 13 patients treated with CT-P13 from the beginning (Naïve group). Infliximab trough levels and antidrug antibodies were measured. RESULTS: At enrolment, patients in the Switched group had a longer median duration of infliximab treatment than Naïve (4.0 vs. 0.6 years, pâ¯<â¯0.0001) but similar proportions of patients were in remission (77% and 62%, respectively). Infliximab discontinuation due to adverse events or loss of efficacy was less common in the Switched (26%) than Naïve group (62%, pâ¯=â¯0.017). Variables independently associated with time to discontinuation were disease activity (pâ¯<â¯0.0001) and immunomodulating treatment (pâ¯=â¯0.019) at enrolment. Trough levels and antidrug antibodies were similar between groups during observation. CONCLUSION: This study confirms that switching from infliximab originator to a first biosimilar is safe and effective. Patients at highest risk of losing treatment efficacy are those with active disease, irrespective of the therapeutic switch.
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Anticorpos Monoclonais/uso terapêutico , Substituição de Medicamentos , Fármacos Gastrointestinais/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Infliximab/sangue , Infliximab/uso terapêutico , Anticorpos Monoclonais/efeitos adversos , Estudos de Casos e Controles , Criança , Pré-Escolar , Feminino , Fármacos Gastrointestinais/sangue , Fármacos Gastrointestinais/farmacocinética , Humanos , Doenças Inflamatórias Intestinais/sangue , Infliximab/farmacocinética , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Análise Multivariada , Estudos Prospectivos , Indução de Remissão , Fatores de TempoRESUMO
Perivascular epithelioid cell tumors (PEComas) are rare mesenchymal tumors that can affect any part of the body. They can be sporadic or arise in the setting of tuberous sclerosis (TSC). In this article, we report a series of three hepatic and two pancreatic PEComas diagnosed preoperatively with ultrasound-guided fine needle aspiration (FNA). All patients were female (age range 28-70), had no personal history of TSC and presented with a single, localized painless mass. Rapid on-site evaluation (ROSE) of cytologic samples was performed for all cases to evaluate for cellular content and adequacy of specimens. Direct smears and cell block preparations revealed a proliferation of medium to large polygonal epithelioid cells, with abundant eosinophilic and vacuolated cytoplasm, arranged in sheets and nests. On immunohistochemistry (IHC), neoplastic cells showed co-expression of melanocytic and smooth muscle markers and a diagnosis of PEComa was rendered. PEComas of the pancreas and liver are rare neoplasms, but should always be considered when examining "clear cell" neoplasms, especially in young female patients. If good quality cytologic samples are obtained by FNA, a correct diagnosis can be achieved with the help of IHC. This is of particular importance in order to plan adequate surgical strategy and to avoid overtreatment.
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Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico/normas , Neoplasias Hepáticas/patologia , Neoplasias Pancreáticas/patologia , Neoplasias de Células Epitelioides Perivasculares/patologia , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos TestesRESUMO
OBJECTIVES: From an Italian Registry of patients with upper gastrointestinal hemorrhage (UGIH), we assessed the clinical outcomes and explored the roles of clinical, endoscopic, and therapeutic factors on 30-day mortality in a real life setting. METHODS: Prospective analysis of consecutive patients endoscoped for UGIH at 23 community and tertiary care institutions from 2003 to 2004. Covariates and outcomes were defined a priori and 30-day follow-up obtained. Logistic regression analysis identified predictors of mortality. RESULTS: One thousand and twenty patients were included. A total of 46 patients died for an overall 4.5% mortality rate. In all, 85% of deaths were associated with one or more major comorbidity. Sixteen of 46 patients (35%) died within the first 24 h of the onset of bleeding. Of these, eight had been categorized as ASA class 1 or 2 and none of them was operated upon, despite a failure of endoscopic intention to treatment in four. Regression analysis showed advanced age, presence of severe comorbidity, low hemoglobin levels at presentation, and worsening health status as the only independent predictors of 30-day mortality (P < 0.001). The acute use of a PPI exerted a protective effect (OR 0.23, 95% CI 0.09-0.73). Recurrent bleeding was low (3.2%). Rebleeders accounted for only 11% of the total patients deceased (OR 3.27, 95% CI 1.5-11.2). CONCLUSIONS: These results indicate that 30-day mortality for nonvariceal bleeding is low. Deaths occurred predominantly in elderly patients with severe comorbidities or those with failure of endoscopic intention to treatment.
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Hemorragia Gastrointestinal/mortalidade , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Endoscopia do Sistema Digestório , Feminino , Nível de Saúde , Hemoglobinas/análise , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Análise de RegressãoRESUMO
The medical management of inflammatory bowel disease has considerably changed thanks to the biologic agents coming. In this review a critical evaluation of controlled studies with biologic agents for the management of both Crohn's disease and ulcerative colitis is presented. The efficacy of these agents in moderate to severe ulcerative colitis and Crohn's disease has been one of the most important advances in the past decades.
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Anticorpos Monoclonais/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Terapia Biológica , HumanosRESUMO
Helicobacter pylori (H. pylori) is a Gram-negative bacterium, usually acquired during childhood, whose natural habitat is the gastric lumen. H. pylori is accepted as the most important cause of gastritis and peptic ulcer in humans. Nevertheless, its important role in the pathogenesis of gastric cancer as well as in several extra-gastroduodenal diseases has been confirmed. The aim of this work is to discuss, for the first time in a single article, all publications concerning H. pylori infection arising from Piedmont region, Italy, where in 1893 Giulio Bizzozero was the first who observed and described spiral organisms in the stomach of animal models. A systematic review of all publications on the management of H. pylori in adults in Piedmont, based on a PubMed and a Scopus research from 1965 to 2017 was performed. The discussed aspects are the epidemiology, the study on gastric and extragastric diseases related to H. pylori, the diagnostic methods, the treatment of H. pylori infection, and the possibility of reinfection. In conclusions, with almost 70 publications, Piedmont has proudly maintained the tradition of the father of the H. pylori.
Assuntos
Infecções por Helicobacter , Helicobacter pylori , Gastroenteropatias/microbiologia , Cardiopatias/microbiologia , Infecções por Helicobacter/complicações , Infecções por Helicobacter/diagnóstico , Infecções por Helicobacter/tratamento farmacológico , Humanos , Itália , Lesões Pré-Cancerosas/microbiologiaRESUMO
BACKGROUND: Infliximab is used for refractory Crohn's disease but there are concerns regarding long-term safety. Recently, JC-polyomavirus (JCV) was studied after 3 cases of progressive multifocal leukoencephalopathy (PML) were found after treatment with natalizumab. The aim of this study was to investigate the short-term effect of infliximab on reactivation of several harmful latent viruses. METHODS: Sixty consecutive patients scheduled for infliximab induction course were prospectively enrolled. Blood samples were taken before each infliximab infusion at 0, 2, 6, and 14 weeks. Specific polymerase chain reaction (PCR) analyses were performed to detect JCV, Epstein-Barr virus (EBV), human herpes virus-6, (HHV-6), -7, -8, and cytomegalovirus (CMV). RESULTS: Indications to infliximab were luminal and fistulizing disease in 49 and 15 cases, respectively. Clinical improvement and remission were achieved in 54 (90%) and 39 (65%) of patients, respectively, at 6 weeks. No patient was JCV-positive at any timepoint. EBV serology was positive for 59/60 patients (98%); EBV-PCR tests were transiently positive (>40 copies/10(5) Peripheral blood mononuclear cells, PBMC) in 4 (7%) patients after infliximab, but in each case were negative at subsequent timepoints. All patients were negative for HHV-6, -7, and -8 at all timepoints. CMV serology was positive in 42 patients (70%), but no CMV-PCR-positive patient was observed. There was no association between concomitant treatments or clinical characteristics and viral status. CONCLUSIONS: Our results support the safety of short-term infliximab treatment with respect to latent virus reactivation. The long-term effects of infliximab, particularly for the issue of lymphoproliferative disorders, warrants further studies with larger populations, but so far data are reassuring.