Eliminating hepatitis C on the Balearic Islands, Spain: a protocol for an intervention study to test and link people who use drugs to treatment and care.

INTRODUCTION: The hepatitis C virus (HCV) is a highly infectious and deadly disease, affecting some 58 million people worldwide. Of the 1.13 million people living in the Balearic Islands, Spain, about 1350 individuals have untreated HCV. Of these, about 1120 (83%) are estimated to be people who use drugs (PWUD), who are one of the key at-risk groups for HCV infection globally. Carrying out micro-elimination approaches focused on this population is crucial to achieve the WHO goal of eliminating HCV by 2030. Thus, the primary objective of this study is to validate a model of care that simplifies the screening and linkage to HCV care pathways for PWUD on the Balearic Islands. METHODS AND ANALYSIS: This intervention study will be implemented across 17 sites, in 4 different settings: addiction service centres (n=12), non-governmental organisation centres (n=3), a mobile methadone unit and a prison, with an estimated 3725 participants. Together with the healthcare staff at each centre, the intervention protocols will be adapted, focusing on four phases: recruitment and testing; linkage to care; treatment for those who test positive; and monitoring of sustained virological response 12 weeks after treatment and reinfection. The primary outcomes will be the number of tested and treated individuals and the secondary outcomes will include individuals lost at each step in the cascade of care. Descriptive analysis and multivariable logistic regression of the data will be undertaken. ETHICS AND DISSEMINATION: The Hospital Clínic Barcelona, Spain, Ethics Committee approved this study on 18 February 2021 (HCB/2020/2018). Findings will be disseminated through peer-reviewed publications, conference presentations and social media. The results of this study could provide a model for targeting PWUD for HCV testing and treatment in the rest of Spain and in other settings, helping to achieve the WHO HCV elimination goal.

Formación básica en endoscopia digestiva para los médicos residentes de la especialidad de Aparato Digestivo. Recomendaciones de la Sociedad Española de Endoscopia Digestiva (SEED) / Basic training in digestive endoscopy for resident physicians in gastroenterology. Recommendations by the Sociedad Española de Endoscopia Digestiva (SEED)

La endoscopia digestiva es la herramienta más efectiva en el diagnóstico de muchas enfermedades del tracto digestivo y constituye una parte esencial en la formación de un médico interno residente (MIR) de Aparato Digestivo. La Sociedad Española de Endoscopia Digestiva (SEED), conocedora de todos los avances técnicos acontecidos en los últimos años, cree necesario definir un programa de competencias que deben adquirir los especialistas de aparato digestivo en formación durante su residencia. En este artículo se describen los objetivos de la formación en endoscopia, las técnicas que se deben conocer y las habilidades que se deben adquirir tanto en diagnóstico como en terapéutica. Finalmente, se propone un modelo para la evaluación de competencias

Digestive endoscopy is the most effective tool available for the diagnosis of multiple gastrointestinal (GI) tract conditions, and it represents a key aspect in the training of gastroenterology residents according to the Spanish MIR (médico interno residente) program. The Sociedad Española de Endoscopia Digestiva (SEED), aware of all the technical advances that have emerged during the past few years, deems it necessary to define a program of the skills specialists-in-training in gastroenterology should acquire during their residency. This paper describes the goals of endoscopy training, the techniques that should be mastered, and the diagnostic and therapeutic skills this specialty requires. Finally, a model is suggested for the assessment of competence

Basic training in digestive endoscopy for resident physicians in gastroenterology. Recommendations by the Sociedad Española de Endoscopia Digestiva (SEED).

Digestive endoscopy is the most effective tool available for the diagnosis of multiple gastrointestinal (GI) tract conditions, and it represents a key aspect in the training of gastroenterology residents according to the Spanish MIR (médico interno residente) program. The Sociedad Española de Endoscopia Digestiva (SEED), aware of all the technical advances that have emerged during the past few years, deems it necessary to define a program of the skills specialists-in-training in gastroenterology should acquire during their residency. This paper describes the goals of endoscopy training, the techniques that should be mastered, and the diagnostic and therapeutic skills this specialty requires. Finally, a model is suggested for the assessment of competence.

Evaluation of the short- and long-term effectiveness and safety of fully covered self-expandable metal stents for drainage of pancreatic fluid collections: results of a Spanish nationwide registry.

BACKGROUND AND AIMS: Initial reports suggest that fully covered self-expandable metal stents (FCSEMSs) may be better suited for drainage of dense pancreatic fluid collections (PFCs), such as walled-off pancreatic necrosis. The primary aim was to analyze the effectiveness and safety of FCSEMSs for drainage of different types of PFCs in a large cohort. The secondary aim was to investigate which type of FCSEMS is superior. METHODS: This was a retrospective, noncomparative review of a nationwide database involving all hospitals in Spain performing EUS-guided PFC drainage. From April 2008 to August 2013, all patients undergoing PFC drainage with an FCSEMS were included in a database. The main outcome measurements were technical success, short-term (2 weeks) and long-term (6 months) effectiveness, adverse events, and need for surgery. RESULTS: The study included 211 patients (pseudocyst/walled-off pancreatic necrosis, 53%/47%). The FCSEMSs used were straight biliary (66%) or lumen-apposing (34%). Technical success was achieved in 97% of patients (95% confidence interval [CI], 93%-99%). Short-term- and long-term clinical success was obtained in 94% (95% CI, 89%-97%) and 85% (95% CI, 79%-89%) of patients, respectively. Adverse events occurred in 21% of patients (95% CI, 16%-27%): infection (11%), bleeding (7%), and stent migration and/or perforation (3%). By multivariate analysis, patient age (>58 years) and previous failed drainage were the most important factors associated with negative outcome. CONCLUSIONS: An FCSEMS is effective and safe for PFC drainage. Older patients with a history of unsuccessful drainage are more likely to fail EUS-guided drainage. The type of FCSEMS does not seem to influence patient outcome.

Transoral endoluminal approach to Zenker's diverticulum using Ligasure™. Early clinical experience.

The development of minimally invasive procedures has rekindled interest in endoluminal techniques for the management of Zenker's diverticulum. Tissue sealers as employed in laparoscopic surgery have not been previously used for Zenker's diverticulum septotomy.Supported by the established safety of linear cutters, bipolar forceps, and ultrasonic scalpels, we have started a procedure using the Ligasure 5™ tissue sealer. Safety and efficacy results in our early clinical experience are shown for a prospective series of 5 consecutive Zenker's diverticulum cases that were perorally managed with tissue sealing.The procedure was quickly and safely performed in the endoscopy room under sedation. Mean number of seals per patient was 2, and mean procedure duration was 33 minutes. No complications developed during or after the procedure, and patients were discharged with immediate dysphagia relief and adequate oral tolerance. No diverticular relapses occurred after a mean follow-up of 21 months (range 18-30). This procedure may be repeated as often as desired with no need for hospital admission. Safety should be prospectively assessed by further studies using a higher number of procedures.

Tratamiento endoluminal transoral del divertículo de Zenker con LigasureTM. Experiencia clínica inicial / Transoral endoluminal approach to Zenker's diverticulum using LigasureTM. Early clinical experience

El desarrollo de los procedimientos mínimamente invasivos ha reavivado el interés por las técnicas endoluminales para el tratamiento del divertículo de Zenker. Los selladores titulares empleados en cirugía laparoscópica no han sido empleados previamente en la septotomía del divertículo de Zenker. Avalados por la seguridad previa del empleo de las cortadoras lineales, de las pinzas bipolares y de los bisturís por ultrasonidos, hemos iniciado dicho procedimiento mediante el empleo del sellador tisular Ligasure 5TM. Se muestran los resultados de seguridad y eficacia en la experiencia clínica inicial de una serie prospectiva de 5 casos consecutivos de divertículo de Zenker tratados por vía peroral con el sellador tisular. El procedimiento se realizó en la sala de endoscopia, con sedación, de manera rápida y segura. La media de sellados por paciente fue de 2 y la duración media del procedimiento de 33 minutos. No se presentaron complicaciones durante el procedimiento ni derivadas del mismo, siendo dados de alta los pacientes con desaparición inmediata de la disfagia y correcta tolerancia oral. Con un seguimiento medio de 21 meses (rango 18-30), no existió recidiva del divertículo en ningún caso. Este procedimiento puede ser repetido tantas veces como se desee y ser realizado sin ingreso hospitalario. La seguridad mostrada deberá ser evaluada prospectivamente en estudios posteriores con mayor número de procedimientos (AU)

The development of minimally invasive procedures has rekindled interest in endoluminal techniques for the management of Zenker’s diverticulum. Tissue sealers as employed in laparoscopic surgery have not been previously used for Zenker’s diverticulum septotomy. Supported by the established safety of linear cutters, bipolar forceps, and ultrasonic scalpels, we have started a procedure using the Ligasure 5TM tissue sealer. Safety and efficacy results in our early clinical experience are shown for a prospective series of 5 consecutive Zenker’s diverticulum cases that were perorally managed with tissue sealing. The procedure was quickly and safely performed in the endoscopy room under sedation. Mean number of seals per patient was 2, and mean procedure duration was 33 minutes. No complications developed during or after the procedure, and patients were discharged with immediate dysphagia relief and adequate oral tolerance. No diverticular relapses occurred after a mean follow-up of 21 months (range 18-30). This procedure may be repeated as often as desired with no need for hospital admission. Safety should be prospectively assessed by further studies using a higher number of procedures (AU)

Hepatitis C treatment and erotomania.

The emergence of psychosis during antiviral therapy for hepatitis C is a rare side effect poorly understood in terms of etiopathogenesis, clinical features and prognosis. Erotomania is a rare psychotic syndrome characterized by the presence of a delusion: the patient (usually a female) is loved by a specific man. We present a patient who began a clinical picture of erotomania that involved his doctor a few days after treatment of interferon and ribavirin was started. He stalked his doctor, forcing the police and the court to intervene. Nevertheless, once antipsychotic treatment was established, symptoms remitted, and the patient continued antiviral treatment successfully.

Antral localization worsens the efficacy of enteral stents in malignant digestive tumors.

BACKGROUND AND AIMS: Malignant gastric outlet obstruction can be treated by means of enteral stenting or surgical gastrojejunalanatomosis. We evaluated in a prospective and multicentre study the efficacy of the enteral stent on food intake, the quality of life impact, and the relationship between efficacy and determined clinical and technical parameters. PATIENTS AND METHODS: Seventy one patients affected by symptoms arising from gastroduodenal obstruction due to malignant tumors, with criteria of irresecability, metastatic disease or very high surgical risk, were treated by means of self expanding metal stents. We used the GOOSS index to evaluate efficacy, and the Euro Qol-5D index to evaluate quality of life. RESULTS: Before stenting patients with GOOSS 0 and 1 were 68 (98.5%). After stenting patients with GOOSS 2 and 3 (semisolid and solid food) were 58 (84,1%) (P<.0001). The Euro Qol-5D index measured before and a month after stenting were 10.17 and 10.04 respectively (P=.6). The median survival was 91 days (9-552). The enteral stents for localised tumors in the duodenum and the gastrojejunalanastomosis were effective in 26 patients (70.2%) and 13 patients respectively (86.6%), while the enteral stents of tumors in the antrum were effective in only 5 patients (29.4%). CONCLUSIONS: The palliative treatment of malignant gastric outlet obstruction with a uncovered metal stent produces a significant improvement of oral food intake and maintains the overall quality of life index. The antral localization is associated with a lower efficacy of the procedure.

Antral localization worsens the efficacy of enteral stents in malignant digestive tumors

Background and aims Malignant gastric outlet obstruction can be treated by means of enteral stenting or surgical gastrojejunalanatomosis. We evaluated in a prospective and multicentre study the efficacy of the enteral stent on food intake, the quality of life impact, and the relationship between efficacy and determined clinical and technical parameters. Patients and methods Seventy one patients affected by symptoms arising from gastroduodenal obstruction due to malignant tumors, with criteria of irresecability, metastatic disease or very high surgical risk, were treated by means of self expanding metal stents. We used the GOOSS index to evaluate efficacy, and the Euro Qol-5D index to evaluate quality of life. Results Before stenting patients with GOOSS 0 and 1 were 68 (98.5%). After stenting patients with GOOSS 2 and 3 (semisolid and solid food) were 58 (84,1%) (P<.0001). The Euro Qol-5D index measured before and a month after stenting were 10.17 and 10.04 respectively (P=.6). The median survival was 91 days (9-552). The enteral stents for localised tumors in the duodenum and the gastrojejunalanastomosis were effective in 26 patients (70.2%) and 13 patients respectively (86.6%), while the enteral stents of tumors in the antrum were effective in only 5 patients (29.4%). Conclusions The palliative treatment of malignant gastric outlet obstruction with a uncovered metal stent produces a significant improvement of oral food intake and maintains the overall quality of life index. The antral localization is associated with a lower efficacy of the procedure (AU)

Antecedentes y objetivos La obstrucción maligna del tracto de salida gástrico puede tratarse mediante el implante de una prótesis enteral o mediante anastomosis yeyunogástrica. Mediante un estudio multicéntrico y prospectivo, evaluamos la eficacia de las prótesis enterales en la ingesta de alimentos, su repercusión en la calidad de vida y la relación entre eficacia y parámetros clínicos y técnicos determinados. Pacientes y métodos Un total de 71 pacientes afectados por síntomas derivados de una obstrucción gastroduodenal ocasionada por neoplasia, con criterios de irresecabilidad, metástasis o riesgo quirúrgico muy elevado, fueron tratados con prótesis metálicas autoexpandibles. Utilizamos el índice GOOSS para evaluar la eficacia, y el Euro Qol-5D para evaluar la calidad de vida. Resultados Antes de implantar la prótesis, 68 (98,5%) pacientes puntuaban GOOSS 0 y 1. Después del implante, el número de pacientes con GOOSS 2 y 3 (alimentos semisólidos y sólidos) era 58 (84,1%) (p<0,0001). El valor del índice Euro Qol-5D antes y un mes después del implante fue 10,17 y 10,04, respectivamente (p=0,6). La mediana de supervivencia fue 91 días (9-552). Las prótesis enterales colocadas para tumores en el duodeno y la anastomosis yeyunogástrica resultaron eficaces en 26 (70,2%) y 13 pacientes, respectivamente (86,6%), mientras que las prótesis colocadas en el antro solo resultaron eficaces en 5 pacientes (29,4%). Conclusiones El tratamiento paliativo de la obstrucción por neoplasia del tracto de salida gástrico con una prótesis metálica sin recubrir produce una mejora significativa de la ingesta oral de alimentos y mantiene la calidad de vida general. La localización antral se asocia con una eficacia inferior del procedimiento (AU)

Susceptibility genetic variants associated with colorectal cancer risk correlate with cancer phenotype.

BACKGROUND & AIMS: Ten common low-penetrant genetic variants have been consistently associated with colorectal cancer (CRC) risk; little is known about the correlation between these variants and CRC phenotype. Characterization of such a correlation would improve CRC management and prevention programs. We assessed the association between these genetic variants and CRC phenotype in patients and modeled pairwise combinations to detect epistasis. METHODS: The validation population corresponded to a prospective, multicenter, population-based cohort (EPICOLON I) of 1096 patients with newly diagnosed CRC. The replication set was an independent, prospective, multicenter Spanish cohort (EPICOLON II) of 895 patients with newly diagnosed CRC. For individual single nucleotide polymorphism (SNP) association analyses, a multivariate method using logistic regression was applied in EPICOLON I and subsequently prospectively validated in EPICOLON II. Interactions between SNPs were assessed using the likelihood ratio test. RESULTS: Validated results confirmed that the C allele on 8q23.3 (rs16892766) was significantly associated with advanced-stage tumors (odds ratio [OR], 1.48; 95% confidence interval [CI], 1.15-1.90; P value = 4.9 x 10(-3)). The G allele on 8q24.21 (rs6983267) was more common in patients with a familial history of CRC (OR, 2.02; 95% CI, 1.35-3.03; P value = 3.9 x 10(-4)). The combination of rs6983267 on 8q24.21 and rs9929218 on 16q22.2 was associated with a history of colorectal adenoma (carriers of GG and AA, respectively; OR, 2.28; 95% CI, 1.32-3.93; P = 5.0 x 10(-4)). CONCLUSIONS: CRC susceptibility variants at 8q23.3, 8q24.21, and 16q22.2 appear to be associated with cancer phenotype. These findings might be used to develop screening and surveillance strategies.

Primary monophasic synovial sarcoma of the duodenum confirmed by cytogenetic analysis with demonstration of t(X;18): a case report.

Synovial sarcoma (SS) is an uncommon malignant neoplasm of the soft tissues. It mainly affects the periarticular tissues of the extremities in young adults, but has been described at nearly all sites; nevertheless, the gastrointestinal tract is an exceptional location. We report a case of a primary synovial sarcoma of the duodenum in a 69-year-old woman. Histological study showed a monophasic pattern. The tumor cells demonstrated diffuse vimentin and Bcl-2 expression, partial EMA expression and focal AE1/3 positivity. The differential diagnosis includes gastrointestinal stromal tumors. Cytogenetic analysis confirmed the diagnosis, with detection of the X;18 translocation. The patient presented postoperative complications and died one month following the intervention.

Hybrid transvaginal cholecystectomy, NOTES, and minilaparoscopy: analysis of a prospective clinical series.

INTRODUCTION: Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. It is not yet possible to perform these interventions without the help of abdominal wall entryways, so these procedures are hybrids, a fusion of minilaparoscopy and transluminal endoscopic surgery. In this paper we present a prospective clinical series of 15 patients who underwent transvaginal hybrid cholecystectomy for cholelithiasis. METHODS: This was a prospective clinical series of 15 consecutive female patients, nonrandomly chosen and without a control group, who underwent a fusion transvaginal NOTES and minilaparoscopy procedure with two entryways for cholelithiasis. One was umbilical and measured 5 mm in diameter, and the other was in the right upper quadrant and measured 3 mm in diameter. RESULTS: The scheduled surgical intervention was performed on the 15 patients in whom it had been indicated. There were no intraoperative complications. One patient had mild hematuria that resolved in less than 12 h; there were no other complications after average follow-up of 124 days. Nine patients were discharged in 24 h, and two were discharged less than 12 h after the procedure. DISCUSSION: Hybrid transvaginal cholecystectomy is a good surgical model for minimally invasive surgery, a combination of NOTES and minilaparoscopy. It can be performed in surgical settings where laparoscopy is practised regularly, using the instruments normally used for endoscopy and laparoscopic surgery. Owing to the reproducibility of the intervention and the ease of vaginal closure, hybrid transvaginal cholecystectomy will permit further development of NOTES in the future.

A prospective, multicenter, population-based study of BRAF mutational analysis for Lynch syndrome screening.

BACKGROUND & AIMS: Mismatch repair (MMR) deficiencies are the hallmark of tumors arising in Lynch syndrome, however, in approximately 15% of sporadic colorectal cancers (CRC) these deficiencies most often are associated with somatic methylation of the MMR gene MLH1. Recently, an oncogenic mutation in the BRAF gene has been involved in sporadic CRC showing MMR deficiencies as a result of MLH1 promoter methylation. The aim of this study was to evaluate the contribution of BRAF V600E mutation analysis in the identification of MSH2/MLH1 gene mutation carriers in newly diagnosed CRC patients. METHODS: BRAF V600E mutation was analyzed in CRC patients with MMR deficiencies (microsatellite instability and/or lack of MLH1/MSH2 protein expression) in the EPICOLON population-based study. The effectiveness and efficiency of different strategies were evaluated with respect to the presence of MSH2/MLH1 germline mutations. RESULTS: MMR deficiencies were detected in 119 of the 1222 CRC patients with tumors showing either microsatellite instability (n = 111) or loss of protein expression (n = 81). BRAF mutation was detected in 22 (18.5%) of the patients. None of the patients with unambiguous germline mutation had BRAF mutation. Regardless of the strategy used to identify MSH2/MLH1 gene carriers, the introduction of BRAF analysis in these patients slightly improves their effectiveness. The introduction of BRAF mutation analysis as a step before germline genetic testing in patients with MMR deficiencies achieved a significant reduction in costs per mutation detected. CONCLUSIONS: Detection of BRAF V600E mutation could simplify and improve the cost effectiveness of genetic testing for hereditary nonpolyposis colorectal cancer, especially in patients whose family history is incomplete or unknown.

Linfoma gástrico tipo MALT / MALT gastric lymphoma

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