Endoscopic ultrasound-guided fiducial placement in pancreatic tumors: safety and technical feasibility

Background and aims: stereotactic body radiation therapy (SBRT) for pancreatic malignancies requires the placement of fiducials to guide treatment delivery. The aim of this study was to assess the safety and feasibility of endoscopic ultrasound (EUS) guided fiducial placement using a 22-gauge needle, in patients with pancreatic cancer undergoing SBRT. Methods: this single-center retrospective study included 47 patients with biopsy-proven advanced pancreatic cancer who underwent EUS-guided fiducial placement between February 2014 and February 2018. Primary outcome measurements included technical success, fiducial migration rate and procedural complications. Results: all 47 patients received a sufficient number of fiducials and could therefore undergo a successful SBRT. The mean number of fiducials inserted per case was 2 +/- 1 (range 1-3) and no fiducial migration was noted. The adverse event rate was 4.2%, as one patient developed mild pancreatitis and another patient required one week of hospitalization one month after fiducial placement due to a duodenal abscess. Conclusions: EUS-guided fiducial placement is a safe and technically feasible procedure in centers with endosonographers that are well trained in EUS with FNA

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Endoscopic ultrasound-guided fiducial placement in pancreatic tumors: safety and technical feasibility.

BACKGROUND AND AIMS: stereotactic body radiation therapy (SBRT) for pancreatic malignancies requires the placement of fiducials to guide treatment delivery. The aim of this study was to assess the safety and feasibility of endoscopic ultrasound (EUS) guided fiducial placement using a 22-gauge needle, in patients with pancreatic cancer undergoing SBRT. METHODS: this single-center retrospective study included 47 patients with biopsy-proven advanced pancreatic cancer who underwent EUS-guided fiducial placement between February 2014 and February 2018. Primary outcome measurements included technical success, fiducial migration rate and procedural complications. RESULTS: all 47 patients received a sufficient number of fiducials and could therefore undergo a successful SBRT. The mean number of fiducials inserted per case was 2 ± 1 (range 1-3) and no fiducial migration was noted. The adverse event rate was 4.2%, as one patient developed mild pancreatitis and another patient required one week of hospitalization one month after fiducial placement due to a duodenal abscess. CONCLUSIONS: EUS-guided fiducial placement is a safe and technically feasible procedure in centers with endosonographers that are well trained in EUS with FNA.

First Case of ROLL Technique for Mesorectal Recurrence Excision.

The radio-guided occult lesion localization (ROLL) technique has been in use since the mid-1990s, mainly in breast surgery. Today, ROLL is used for numerous oncologic pathologies, including parathyroid lesions, melanomas, and colorectal tumors. We report a patient with an 11-mm left mesorectal solitary recurrence of a primary ovarian cancer in whom the ROLL technique was used to identify the implant. A radioisotope was introduced through a 22-gauge needle with endoscopic ultrasound technique using an linear echo endoscope. On the day of surgery, the patient's perianal region was scanned with a gamma probe to identify the area of maximal radioactivity, to determine the optimal placement of the incision over the lesion. After macroscopic excision of the lesion, radioactivity was measured in the lesion bed to ensure complete removal of affected tissues. In our case, the ROLL technique was performed safely for the detection and excision of a recurrent lesion of difficult identification. To our knowledge, this is the first reported case involving use of the ROLL technique to aid the excision of a mesorectal lesion.

Incidencia a los 2 años de nuevas enfermedades inflamatorias mediadas por inmunidad en la cohorte de pacientes con enfermedad inflamatoria intestinal del estudio AQUILES / Two-year incidence of new immune-mediated inflammatory diseases in patients with inflammatory bowel disease: A study in the AQUILES cohort

OBJETIVO: Describir la incidencia a los 2 años de nuevas enfermedades inflamatorias mediadas por inmunidad (espondiloartritis, uveítis, psoriasis) en la cohorte de pacientes con enfermedad inflamatoria intestinal (EII) del estudio AQUILES. MATERIAL Y MÉTODOS: Durante un periodo de 2 años se siguieron 341 pacientes con EII (53% mujeres, edad media 40 años) diagnosticados de enfermedad de Crohn (60,5%), colitis ulcerosa (38,1%) y colitis indeterminada (1,4%). Los nuevos diagnósticos durante el seguimiento de los pacientes se basaron en los informes de los respectivos especialistas (reumatólogos, oftalmólogos y dermatólogos). RESULTADOS: Se establecieron 22 nuevos diagnósticos de enfermedades inflamatorias mediadas por inmunidad en 21 pacientes (incidencia acumulada: 6,5% [intervalo de confianza del 95% -IC 95%-: 3,7-9,2], tasa de incidencia: 26 casos por 10.000 pacientes-año). La mayoría de los diagnósticos fueron nuevos casos de espondiloartritis (n=15). La incidencia acumulada de nuevos diagnósticos de enfermedades inflamatorias mediadas por inmunidad fue similar en pacientes con enfermedad de Crohn (5,8%, IC 95%: 3,4-9,9) y en pacientes con colitis ulcerosa (7,7%, IC 95%: 4,2-13,6). En el análisis multivariable la incidencia de nuevas enfermedades inflamatorias mediadas por inmunidad se asoció a historia familiar de EII (odds ratio=3,6, IC 95%: 1,4-9,4) y a la presencia de manifestaciones extraintestinales de EII (odds ratio=1,8, IC 95%: 0,7-5,2). CONCLUSIONES: En pacientes con EII la incidencia de nuevas enfermedades inflamatorias mediadas por inmunidad a los 2 años de seguimiento fue del 6,5%, siendo más frecuentes en pacientes con manifestaciones extraintestinales de EII e historia familiar de EII

OBJECTIVE: To describe the 2-year incidence of new immune-mediated inflammatory diseases (spondylarthritis, uveitis, psoriasis) in the cohort of patients with inflammatory bowel disease (IBD) included in the AQUILES study. MATERIALS AND METHODS: Over a 2-year period, 341 patients with IBD (53% women, mean age 40 years) diagnosed with Crohn's disease (60.5%), ulcerative colitis (38.1%) and indeterminate colitis (1.4%) were followed up. New diagnoses made during follow-up were based on reports of the corresponding specialists (rheumatologists, ophthalmologists, and dermatologists). RESULTS: A total of 22 new diagnoses of immune-mediated inflammatory diseases were established in 21 patients (cumulative incidence of 6.5%, 95% confidence interval [CI] 3.7-9.2, incidence rate of 26 cases per 10,000 patient-years). Most diagnoses were new cases of spondylarthritis (n=15). The cumulative incidence of new diagnoses of immune-mediated inflammatory diseases was similar in patients with Crohn's disease (5.8%, 95% CI 3.4-9.9) and in patients with ulcerative colitis (7.7%, 95% CI 4.2-13.6). On multivariate analysis, the incidence of new immune-mediated inflammatory diseases was significantly associated with a family history of IBD (odds ratio=3.6, 95% CI 1.4-9.4) and the presence of extraintestinal manifestations of IBD (odds ratio=1.8, 95% CI .7-5.2). CONCLUSIONS: In patients with IBD, the incidence of new immune-mediated inflammatory diseases at 2 years of follow-up was 6.5%. These diseases were more frequent in patients with extraintestinal manifestations of IBD and a family history of IBD

[Two-year incidence of new immune-mediated inflammatory diseases in patients with inflammatory bowel disease: A study in the AQUILES cohort]. / Incidencia a los 2 años de nuevas enfermedades inflamatorias mediadas por inmunidad en la cohorte de pacientes con enfermedad inflamatoria intestinal del estudio AQUILES.

OBJECTIVE: To describe the 2-year incidence of new immune-mediated inflammatory diseases (spondylarthritis, uveitis, psoriasis) in the cohort of patients with inflammatory bowel disease (IBD) included in the AQUILES study. MATERIALS AND METHODS: Over a 2-year period, 341 patients with IBD (53% women, mean age 40 years) diagnosed with Crohn's disease (60.5%), ulcerative colitis (38.1%) and indeterminate colitis (1.4%) were followed up. New diagnoses made during follow-up were based on reports of the corresponding specialists (rheumatologists, ophthalmologists, and dermatologists). RESULTS: A total of 22 new diagnoses of immune-mediated inflammatory diseases were established in 21 patients (cumulative incidence of 6.5%, 95% confidence interval [CI] 3.7-9.2, incidence rate of 26 cases per 10,000 patient-years). Most diagnoses were new cases of spondylarthritis (n=15). The cumulative incidence of new diagnoses of immune-mediated inflammatory diseases was similar in patients with Crohn's disease (5.8%, 95% CI 3.4-9.9) and in patients with ulcerative colitis (7.7%, 95% CI 4.2-13.6). On multivariate analysis, the incidence of new immune-mediated inflammatory diseases was significantly associated with a family history of IBD (odds ratio=3.6, 95% CI 1.4-9.4) and the presence of extraintestinal manifestations of IBD (odds ratio=1.8, 95% CI .7-5.2). CONCLUSIONS: In patients with IBD, the incidence of new immune-mediated inflammatory diseases at 2 years of follow-up was 6.5%. These diseases were more frequent in patients with extraintestinal manifestations of IBD and a family history of IBD.

Enfermedades inflamatorias mediadas por inmunidad en pacientes con enfermedad inflamatoria intestinal. Datos basales del estudio Aquiles / Immune-mediated inflammatory diseases in patients with inflammatory bowel disease. Baseline data from the Aquiles study

OBJETIVO: Determinar la prevalencia de enfermedades inflamatorias mediadas por inmunidad (EIMI) en una cohorte de pacientes con enfermedad inflamatoria intestinal (EII) reclutada en consultas hospitalarias de aparato digestivo para el estudio Aquiles, un estudio prospectivo de 2 años de seguimiento. Material y métodos Se incluyeron pacientes de ≥ 18 años con diagnóstico previo o nuevo de EII (enfermedad de Crohn [EC], colitis ulcerosa [CU] o colitis indeterminada). Los diagnósticos se recogieron de forma transversal de la historia clínica en el momento de incorporar a cada paciente al estudio. Resultados Se incluyeron 526 pacientes (edad media 40,2 años; 47,3% hombres, 52,7% mujeres), 300 con EC (57,0%), 218 con CU (41,4%) y 8 colitis indeterminada. Presentaron otra EIMI 71 pacientes (prevalencia: 13,5%, IC 95%: 10,8-16,7): 47 fueron espondiloartritis (prevalencia: 8,9%); 18 psoriasis (3,4%); 5 pioderma gangrenoso (1,0%) y 11 uveítis (2,1%). La prevalencia de EIMI fue mayor en pacientes con EC respecto a pacientes con CU (17,0% [IC 95%: 13,2-21,7] frente a 9,2% [IC 95%: 6,0-13,8], p = 0,011). En el análisis multivariante, las variables asociadas a la presencia de EIMI fueron el diagnóstico de EC (OR = 1,8 [IC 95%: 1,1-3,2]) y un tiempo de evolución de la EII ≥ 4 años (OR = 2,1 [IC 95%: 1,1-4,1] en aquellos con 4-8 años, y OR = 2,1 [IC 95%: 1,2-3,9] en los de ≥ 8 años frente a < 4 años). CONCLUSIONES: En la cohorte de pacientes con EII del estudio Aquiles, el 13,5% presentó otra EIMI, con una prevalencia mayor en pacientes con EC y > 4 años de evolución de la enfermedad

OBJECTIVE: To determine the prevalence of immune-mediated inflammatory diseases (IMID) in a cohort of patients with inflammatory bowel disease(IBD) enrolled in hospital gastroenterology outpatients units for the AQUILES study, a prospective 2-year follow-up study. MATERIAL AND METHODS: We included patients ≥18 years old with a prior or new diagnosis of IBD (Crohn disease [CD], ulcerative colitis [UC] or indeterminate colitis). Diagnoses were collected in a cross-sectional manner from the clinical records at enrollment of a new patient in the study. RESULTS: We included 526 patients (mean age 40.2 years; 47.3% men, 52.7% women), 300 with CD (57.0%), 218 with UC (41.4%) and 8 with indeterminate colitis. Other types of IMID were present in 71 patients (prevalence: 13.5%, 95% CI: 10.8-16.7): 47 were spondyloarthropathies (prevalence: 8.9%); 18 psoriasis (3.4%); 5 pyoderma gangrenosum (1.0%), and 11 uveitis (2.1%). The prevalence of IMID was higher in patients with CD than in those with UC (17.0% [95% CI: 13.2-21.7] vs 9.2% [95% CI: 6.0-13.8], p=0.011). In the multivariate analysis, the variables associated with the presence of IMID were diagnosis of CD (OR=1.8 [95% CI: 1.1-3.2]) and duration of IBD ≥4 years (OR=2.1 [95% CI: 1.1-4.1] in those with disease duration 4-8 years, and OR=2.1 [95% CI: 1.2-3.9] in those with ≥8 years vs. <4 years).CONCLUSIONS: In the cohort of patients with IBD in the AQUILES study, 13.5% had another IMID, with a higher prevalence in patients with CD and>4 years since disease onset (AU)

[Immune-mediated inflammatory diseases in patients with inflammatory bowel disease. Baseline data from the Aquiles study]. / Enfermedades inflamatorias mediadas por inmunidad en pacientes con enfermedad inflamatoria intestinal. Datos basales del estudio Aquiles.

OBJECTIVE: To determine the prevalence of immune-mediated inflammatory diseases (IMID) in a cohort of patients with inflammatory bowel disease (IBD) enrolled in hospital gastroenterology outpatients units for the AQUILES study, a prospective 2-year follow-up study. MATERIAL AND METHODS: We included patients ≥18 years old with a prior or new diagnosis of IBD (Crohn disease [CD], ulcerative colitis [UC] or indeterminate colitis). Diagnoses were collected in a cross-sectional manner from the clinical records at enrollment of a new patient in the study. RESULTS: We included 526 patients (mean age 40.2 years; 47.3% men, 52.7% women), 300 with CD (57.0%), 218 with UC (41.4%) and 8 with indeterminate colitis. Other types of IMID were present in 71 patients (prevalence: 13.5%, 95% CI: 10.8-16.7): 47 were spondyloarthropathies (prevalence: 8.9%); 18 psoriasis (3.4%); 5 pyoderma gangrenosum (1.0%), and 11 uveitis (2.1%). The prevalence of IMID was higher in patients with CD than in those with UC (17.0% [95% CI: 13.2-21.7] vs 9.2% [95% CI: 6.0-13.8], p=0.011). In the multivariate analysis, the variables associated with the presence of IMID were diagnosis of CD (OR=1.8 [95% CI: 1.1-3.2]) and duration of IBD ≥4 years (OR=2.1 [95% CI: 1.1-4.1] in those with disease duration 4-8 years, and OR=2.1 [95% CI: 1.2-3.9] in those with ≥8 years vs. <4 years). CONCLUSIONS: In the cohort of patients with IBD in the AQUILES study, 13.5% had another IMID, with a higher prevalence in patients with CD and>4 years since disease onset.

Usefulness of endoscopic ultrasonography in the clinical suspicion of biliary disease.

BACKGROUND AND AIMS: endoscopic ultrasound (EUS) is a very sensitive and specific technique for the diagnosis of biliary diseases. This procedure has proven its usefulness in cases of high suspicion of biliary disease (history of gallstones and dilatation of the intrahepatic and/or extrahepatic bile ducts). We know less about its usefulness in cases of low suspicion of biliary pathology.The aim of this study was to assess the diagnostic accuracy of EUS in patients with low suspicion of biliary disease (patients with dilatation of the biliary tract were excluded). METHODS: 33 patients with low suspicion of biliary disease were recruited in 12 months. All of them had no biliary findings in a previous abdominal ultrasound and computer tomography scan. All of them underwent EUS and were studied prospectively. The diagnosis was confirmed by surgery and/or by ERCP in patients with positive EUS or clinical follow-up in those with normal EUS. Time of follow-up was 9 months (range, 3-12 months). RESULTS: seventeen patients (51.5%) presented with abnormal biliary findings on EUS (7 choledocholithiasis, 3 cholelithiasis, 2 choledocholithiasis + cholelithiasis and 5 microlithiasis). CONCLUSION: EUS is a useful and safe procedure for diagnosing patients with low suspicion of biliary disease.

Utilidad de la ultrasonografía endoscópica en la sospecha clínica de patología biliar / Usefulness of endoscopic ultrasonography in the clinical suspicion of biliary disease

Antecedentes y objetivos: la ultrasonografía endoscópica (USE) es una técnica muy sensible y específica para el diagnóstico de enfermedades biliares. Este procedimiento ha demostrado su utilidad en casos de alta sospecha de enfermedad biliar (historia de colelitiasis y dilatación de la vía biliar intra- y/o extrahepática). Sabemos menos sobre su utilidad en casos de baja sospecha de patología biliar. El objetivo de este estudio fue evaluar la precisión diagnóstica de la USE en pacientes con baja sospecha de enfermedad biliar (los pacientes con dilatación de la vía biliar fueron excluidos). Métodos: 33 pacientes con baja sospecha de enfermedad biliar fueron reclutados en 12 meses. Todos ellos presentaban una ecografía abdominal previa y un TAC sin hallazgos relevantes. Todos se sometieron a una USE y se estudiaron de forma prospectiva. El diagnóstico fue confirmado con los hallazgos quirúrgicos y/o con la colangiopancreatografía retrógrada endoscópica (CPRE) en pacientes con USE positiva o con seguimiento clínico en pacientes con USE normal. El tiempo de seguimiento medio fue de 9 meses (3- 12 meses). Resultados: diecisiete pacientes (51,5%) presentaron patología biliar en la USE (7 coledocolitiasis, 3 colelitiasis, 2 colelitiasis + coledocolitiasis y 5 microlitiasis). Conclusión: la USE es un procedimiento útil y seguro para el diagnóstico de pacientes con baja sospecha de enfermedad biliar(AU)

Background and aims: endoscopic ultrasound (EUS) is a very sensitive and specific technique for the diagnosis of biliary diseases. This procedure has proven its usefulness in cases of high suspicion of biliary disease (history of gallstones and dilatation of the intrahepatic and/or extrahepatic bile ducts). We know less about its usefulness in cases of low suspicion of biliary pathology. The aim of this study was to assess the diagnostic accuracy of EUS in patients with low suspicion of biliary disease (patients with dilatation of the biliary tract were excluded). Methods: 33 patients with low suspicion of biliary disease were recruited in 12 months. All of them had no biliary findings in a previous abdominal ultrasound and computer tomography scan. All of them underwent EUS and were studied prospectively. The diagnosis was confirmed by surgery and/or by ERCP in patients with positive EUS or clinical follow-up in those with normal EUS. Time of followup was 9 months (range, 3-12 months). Results: seventeen patients (51.5%) presented with abnormal biliary findings on EUS (7 choledocholithiasis, 3 cholelithiasis, 2 choledocholithiasis + cholelithiasis and 5 microlithiasis). Conclusion: EUS is a useful and safe procedure for diagnosing patients with low suspicion of biliary disease(AU)

Open-label infliximab therapy in ulcerative colitis: a multicenter survey of results and predictors of response.

BACKGROUND/AIMS: Results of randomized controlled trials showing efficacy of infliximab in ulcerative colitis (UC) should be confirmed in clinical practice. We aimed to evaluate the efficacy and safety of infliximab in UC patients of the Madrid area, looking for clinical predictors of response. METHODOLOGY: Multicenter retrospective survey of all UC patients treated with infliximab in the region of Madrid (Spain). RESULTS: 47 UC patients were included (45% males, mean age 44 +/- 15 yrs), mean follow up of 4.7 months (range 0.5-21), and a total number of 211 infliximab infusions. Clinical response and steroid-free remission rates were, respectively, 97/42% in the 2nd week, 93/69% in the 6th week, and 80/65% at the long-term follow up (mean 8.2 months, range 3.5-21). Colectomy rate was 10.6% (five patients). Age, gender, disease duration, indication (steroid-resistance/dependence), disease severity, C-reactive protein, concomitant thiopurinic therapy or smoking habit did not influence on efficacy. Extent of the disease was the only predictive factor (p=0.02). Only 4 cases of mild adverse events were reported. CONCLUSIONS: Infliximab is effective and safe for UC. Real life clinical practice may have better outcome than showed in randomized controlled trials. Extent of the disease was the only predictive factor for clinical response in our experience.

Long-term oral tacrolimus therapy in refractory to infliximab fistulizing Crohn's disease: a pilot study.

AIMS: To evaluate efficacy and safety of oral tacrolimus in cases of fistulizing Crohn's disease (FCD), which is refractory to conventional therapy including infliximab. METHODS: Patients with fistulas, previously and unsuccessfully treated with all conventional therapy (i.e., antibiotics, azathioprine, or 6-mercaptopurine and infliximab), were enrolled in a prospective, uncontrolled, open-label study of long-term treatment with oral tacrolimus (0.05 mg/kg every 12 h). The evaluation of the clinical response was complemented by use of the perianal Crohn's disease activity index (PCDAI) and magnetic resonance imaging-based score (MRS) with determined periodicity. RESULTS: Ten patients were included in the study (enterocutaneous fistula, 3 patients; perianal fistula, 4 patients; rectovaginal fistula, 3 patients) with 6 to 24 months of follow-up. Five patients were steroid-dependent, and 4 patients needed maintenance treatment with immunosuppressant agents. Four patients (40%) achieved complete clinical responses, which were verified by PCDAI and MRS. Five patients (50%) achieved partial responses (i.e., important decreases in fistula drainage, size, discomfort, and PCDAI/MRS values). Decreases in both the PCDAI and MRS were statistically significant (P < 0.05). All steroid-dependent patients stopped therapy with prednisone, and concomitant immunosuppressive therapy was tapered. The response was maintained, and no new flare-up of the disease was observed. Only mild adverse events were detected (1 patient withdrew from treatment due to headache), and no case of nephrotoxicity or diabetes was detected. One patient had received no benefit from therapy after 6 months. CONCLUSIONS: Oral tacrolimus could be an effective and safe treatment for patients with FCD, even if there has been no response to infliximab treatment. Randomized studies are needed to compare oral tacrolimus with infliximab in terms of efficacy, safety, and costs.