Low dose thymoglobulin versus basiliximab in cytomegalovirus positive kidney transplant recipients: Effectiveness of preemptive cytomegalovirus modified strategy / Timoglobulina en dosis bajas vs. basiliximab en receptores de trasplante renal positivos para citomegalovirus: efectividad de una estrategia preventiva modificada

Background: We performed a retrospective trial to determine asymptomatic CMV reactivation and CMV disease in kidney allograft recipients with positive CMV serostatus. Methods: Preemptive modified strategy under low dose thymoglobulin versus basiliximab induction was evaluated. Patients were monitored by CMV-polymerase chain reaction (PCR); if the viral load was >4000copies/μl, they received valganciclovir adjusted for their renal function. Results: 132 recipients were included in the study, 84 and 48 receiving basiliximab and thymoglobulin induction respectively, and followed up for 12 months. Asymptomatic CMV reactivation was significantly higher for thymoglobulin (77.1% vs. 16.7%, p<0.001). Treatment groups had similar rates of CMV disease (3.6% vs. 2.1%, p 0.538). The significant difference in asymptomatic CMV reactivation between two treatment groups did not have any impact on 1 year graft function (71±26ml/min vs. 74±19ml/min; p=0.475) and no histological differences in protocol biopsies were observed among patients with asymptomatic CMV reactivation vs those without CMV reactivation. Conclusions: Due to the high asymptomatic CMV reactivation incidence in patients who received thymoglobulin induction, our results suggest that valganciclovir prophylaxis may be advantageous in CMV seropositive renal transplant recipients after low dose thymoglobulin induction. A preemptive strategy appeared to significantly reduce the likelihood of CMV disease in both groups. Rejection risk and negative impact in renal function associated with asymptomatic CMV reactivation was not found in our series. (AU)

Antecedentes: Llevamos a cabo un estudio retrospectivo para determinar la reactivación y enfermedad por CMV en receptores de trasplante renal CMV seropositivos bajo diferentes esquemas de inducción. Métodos: Una estrategia preventiva modificada bajo inducción con basiliximab y timoglobulina en dosis bajas fue evaluada. Se llevó a cabo un seguimiento de la carga viral-reacción de cadena de la polimerasa-CMV; los valores mayores de 4000 copias/μl recibieron valganciclovir ajustado a la función renal. Resultados: Un total de 132 receptores de trasplante renal fueron incluidos; 84 y 48 recibieron inducción con basiliximab y timoglobulina respectivamente. Seguimiento hasta el mes 12 postrasplante. La reactivación asintomática de CMV fue significativamente mayor para timoglobulina (77,1% vs. 16,7%, p<0,001). La tasa de enfermedad por CMV fue similar en ambos grupos de tratamiento (3,6% vs. 2,1%, p=0,538). Ningún impacto en la función renal un año postrasplante fue encontrado entre los grupos a pesar de la diferencia significativa en reactivación asintomática de CMV (71±26ml/min vs. 74±19ml/min; p=0,475); igualmente, no encontramos diferencias en los hallazgos histológicos en biopsias por protocolo entre receptores con reactivación asintomática por CMV y aquellos sin reactivación. Conclusiones: La alta incidencia de reactivación asintomática por CMV en receptores seropositivos a pesar del uso de bajas dosis de timoglobulina sugiere que la profilaxis con valganciclovir es una estrategia apropiada en este grupo; sin embargo, una estrategia preventiva reduce significativamente la probabilidad de enfermedad por CMV en ambos grupos de tratamiento. El riesgo de rechazo y el impacto negativo en la función renal asociado a la reactivación asintomática por CMV no fue encontrado en nuestra experiencia.

Low dose thymoglobulin versus basiliximab in cytomegalovirus positive kidney transplant recipients: Effectiveness of preemptive cytomegalovirus modified strategy.

BACKGROUND: We performed a retrospective trial to determine asymptomatic CMV reactivation and CMV disease in kidney allograft recipients with positive CMV serostatus. METHODS: Preemptive modified strategy under low dose thymoglobulin versus basiliximab induction was evaluated. Patients were monitored by CMV-polymerase chain reaction (PCR); if the viral load was >4000copies/µl, they received valganciclovir adjusted for their renal function. RESULTS: 132 recipients were included in the study, 84 and 48 receiving basiliximab and thymoglobulin induction respectively, and followed up for 12 months. Asymptomatic CMV reactivation was significantly higher for thymoglobulin (77.1% vs. 16.7%, p<0.001). Treatment groups had similar rates of CMV disease (3.6% vs. 2.1%, p 0.538). The significant difference in asymptomatic CMV reactivation between two treatment groups did not have any impact on 1 year graft function (71±26ml/min vs. 74±19ml/min; p=0.475) and no histological differences in protocol biopsies were observed among patients with asymptomatic CMV reactivation vs those without CMV reactivation. CONCLUSIONS: Due to the high asymptomatic CMV reactivation incidence in patients who received thymoglobulin induction, our results suggest that valganciclovir prophylaxis may be advantageous in CMV seropositive renal transplant recipients after low dose thymoglobulin induction. A preemptive strategy appeared to significantly reduce the likelihood of CMV disease in both groups. Rejection risk and negative impact in renal function associated with asymptomatic CMV reactivation was not found in our series.

Posterior hamstring harvest improves aesthetic satisfaction and decreases sensory complications as compared to the classic anterior approach in anterior cruciate ligament reconstruction surgery.

PURPOSE: The use of the posterior approach for harvesting hamstring grafts has recently become popular thanks to new all-inside techniques and retrograde drills. This study aims to compare the classic anterior approach with the posterior approach in the popliteal fossa. METHODS: Retrospective comparative study of 100 consecutive cases of primary ligamentoplasty performed using ipsilateral semitendinosus autograft with at least one year of follow-up. 50 patients with anterior approach (group A) and 50 patients with posterior approach (P). Ratio men/women: 9/1. Mean age: 32 ± 13 years. Mean operative time: 64.88 ± 12.28 min. STUDY VARIABLES: Graft harvest time; intraoperative complications (semitendinous [ST] tendon cut); postoperative neurological complications (allodynia, paresthesia, pain) or hematoma in the donor area; atrophy of the operated thigh compared to the contralateral thigh, postoperative VAS score, aesthetic satisfaction and overall satisfaction. RESULTS: Graft harvest time of 9.5 min in group A versus 5.25 min in group P (p < 0.05). Sensory complications: 16% in group A versus 2% in group P (p < 0.05). Regarding the patient's evaluation of the aesthetic result of the surgery, 80% in group A and 92% in group P were very satisfied, 16% in group A and 8% in group P were satisfied and 4% in group A and no patients in group P not very satisfied (p < 0.05). No significant differences were found in terms of total operative time, postoperative joint movement, atrophy of the operated thigh, postoperative VAS, or overall patient satisfaction. CONCLUSIONS: The posterior approach to harvesting the ipsilateral hamstring graft obtained better results than the anterior approach in terms of aesthetic satisfaction of the patient, lower rate of neurological complications (allodynia, paresthesias and hypoesthesia in the anterior region of the knee and leg) and shorter hamstring harvest time. LEVEL OF EVIDENCE: IV.

Do Clinical Trials Meet Current Care Needs? Views of Digestive Oncology Specialists in Galicia (Spain) Using the Delphi Method.

Background: In recent years, abundant scientific evidence has been generated based on clinical trials (CT) in the field of oncology. The general objective of this paper is to find out the extent to which decision making is based on knowledge of the most recent CT. Its specific objectives are to pinpoint difficulties with decision making based on the CT performed and find out the motivations patients and clinicians have when taking part in a CT. Methodology: Combined, prospective study, based on the Delphi method. A lack of correspondence between the people who take part in CT and patients who come for consultation has been identified. A need for training in analysing and interpreting CT has also been identified and a lack of trust in the results of CT financed by the pharmaceutical industry itself has been perceived. Conclusions: There is a difficulty in selecting oncological treatment due to the lack of correspondence between the patients included in the CT and patients seen in consultation. In this process, real world data studies may be highly useful, as they may provide this group with greater training in interpreting CT and their results.

Phase II clinical trial of nab-paclitaxel plus gemcitabine in elderly patients with previously untreated locally advanced or metastatic pancreatic adenocarcinoma: the BIBABRAX study.

PURPOSE: To evaluate the health-related quality of life (HRQoL), global health status (GHS), and deterioration-free survival of an elderly population (> 70 years) with unresectable locally advanced (LAPC) or metastatic pancreatic cancer (mPC) treated with nab-paclitaxel in combination with gemcitabine. METHODS: In this open-label, single-arm, multicenter, phase II trial, patients received 4-week cycles of intravenous (i.v.) nab-paclitaxel at a dose of 125 mg/m2, followed by i.v. injections of gemcitabine at a dose of 1000 mg/m2 on days 1, 8 and 15 until disease progression or unacceptable toxicity was observed. The primary outcome was the HRQoL (deterioration-free rate at 3 months as evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. RESULTS: Eighty patients (median age: 74.6 years) were enrolled (56 with mPC, 24 with LAPC). The percentage of patients who had not experienced deterioration at 3 months was 54.3% (95% CI 41.6-67.0%). The median (interquartile range) time until definite deterioration was 1.6 (1.1-3.7) months. The objective response rate and clinical benefit rate were achieved by 11 (13.8%, 95% CI 6.2-21.3%) and 54 patients (67.5%, 95% CI 57.2-77.8%), respectively. The median overall survival was 9.2 months (95% CI 6.9-11.5), and the median progression-free survival was 7.2 months (95% CI 5.8-8.5). Only fatigue and neutropenia demonstrated a grade 3-4 toxicity incidence > 20%. CONCLUSIONS: Our study confirms the clinical benefit of the combination of nab-paclitaxel and gemcitabine in an elderly population with pancreatic cancer in terms of improved survival and clinical response. However, we were unable to confirm a benefit in terms of quality-of-life.

FOLFOXIRI plus bevacizumab versus FOLFOX plus bevacizumab for patients with metastatic colorectal cancer and ≥3 circulating tumour cells: the randomised phase III VISNÚ-1 trial.

PURPOSE: 5-Fluorouracil/leucovorin, oxaliplatin, irinotecan (FOLFOXIRI) plus bevacizumab is more effective than doublets plus bevacizumab as first-line therapy for metastatic colorectal cancer, but is not widely used because of concerns about toxicity and lack of predictive biomarkers. This study was designed to explore the role of circulating tumour cell (CTC) count as a biomarker to select patients for therapy with FOLFOXIRI-bevacizumab. PATIENTS AND METHODS: VISNÚ-1 was a multicentre, open-label, randomised, phase III study in patients with previously untreated, unresectable, metastatic colorectal carcinoma and ≥3 CTC/7.5 mL blood. Patients received bevacizumab 5 mg/kg plus FOLFOXIRI (irinotecan 165 mg/m2, oxaliplatin 85 mg/m2, leucovorin 400 mg/m2 and 5-fluorouracil 3200 mg/m2) or FOLFOX (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-fluorouracil 400 mg/m2 then 2400 mg/m2) by intravenous administration every 2 weeks. The primary outcome was progression-free survival (PFS). RESULTS: The intention-to-treat population comprised 349 patients (FOLFOXIRI-bevacizumab, n=172; FOLFOX-bevacizumab, n=177). Median PFS was 12.4 months (95% CI 11.2 to 14.0) with FOLFOXIRI bevacizumab and 9.3 months (95% CI 8.5 to 10.7) with FOLFOX-bevacizumab (stratified HR, 0.64; 95% CI 0.49 to 0.82; p=0.0006). Grade≥3 adverse events were more common with FOLFOXIRI-bevacizumab 85.3% vs 75.1% with FOLFOX-bevacizumab (p=0.0178). Treatment-related deaths occurred in 8 (4.7%) and 6 (3.4%) patients, respectively. CONCLUSIONS: First-line FOLFOXIRI-bevacizumab significantly improved PFS compared with FOLFOX-bevacizumab in patients with metastatic colorectal cancer and ≥3 CTCs at baseline, which indicate a poor prognosis. CTC count may be a useful non-invasive biomarker to assist with the selection of patients for intensive first-line therapy.

First-line panitumumab plus capecitabine for the treatment of older patients with wild-type RAS metastatic colorectal cancer. The phase II, PANEL study.

BACKGROUND: Despite the high morbidity and mortality of metastatic colorectal cancer (mCRC) in older patients, they have been underrepresented in clinical trials and their optimal treatment is yet to be determined. This open-label phase II study evaluated the benefits of panitumumab and capecitabine as a first-line chemotherapy regimen in older patients with wild-type [WT] RAS mCRC. PATIENTS AND METHODS: Patients (≥70 years; ECOG≤2) received 3-week cycles of panitumumab (9 mg/kg on day 1) plus capecitabine (850 mg/m2 twice daily on days 1-14) until disease progression or unacceptable toxicity. Response was evaluated every 9 weeks according to RECIST_1.1. Outcome measures were: objective response rate (ORR), duration of response (DoR), time to response (TTR), progression (TTP) and treatment failure (TTF), progression-free survival (PFS), overall survival (OS), and safety. RESULTS: Twenty-seven patients (11 women; median age: 78 years; ECOG: 0 [26%], 1 [67%], 2 [7%]) were evaluated. Median follow-up was 17.7 months. Confirmed ORR (95%CI) was 44.4% (25.7-63.2), with 25.9% of patients achieving at least stable disease. Median (95%CI) DoR was 8.7 (5.5-10.4) months, and median TTR was 2.2 (1.9-2.8) months. Median TTP was 9.6 (4.8-11.5) months, with a median TTF of 5.2 (2.8-7.2) months. The median PFS was 7.5 (4.4-10.4) months, and the median OS was 23.7 (7.4-27.5) months. Seventeen (63%) patients reported panitumumab and/or capecitabine-related adverse events grade 3-4, with skin toxicity (18.5%) being the most common. Two (7.4%) deaths were treatment-related. CONCLUSION: This study suggests that panitumumab plus capecitabine is a safe and effective regimen in older patients with WT RAS mCRC.

Efficacy and safety of FOLFIRI/aflibercept in second-line treatment of metastatic colorectal cancer in a real-world population: Prognostic and predictive markers.

PURPOSE: The phase III VELOUR trial demonstrated efficacy with combined FOLFIRI-aflibercept in patients with metastatic colorectal cancer previously treated with oxaliplatin with or without bevacizumab versus placebo. The effect of FOLFIRI-aflibercept in routine clinical practice was evaluated. METHODS/PATIENTS: Overall survival (OS), progression-free survival (PFS), response and safety were analysed for 78 patients treated with FOLFIRI-aflibercept at six GITuD institutions. Exploratory analyses of prognostic and predictive markers of efficacy were performed. RESULTS: Patients had good general status (PS 0-1 96.2%), tumours were mostly RAS-mutant (75.6%), synchronous (71.8%), and left-sided (71.8%). Prior therapy included bevacizumab (47.4%) and anti-EGFR agents (12.8%). PFS was longer for metachronous than synchronous tumours (11.0 vs 5.0 months, P = 0.028), and for left-colon tumours (7.0 vs 3.0 months, P = 0.044). RAS-mutant status, first-line treatment and primary tumour surgery did not impact PFS. The disease control rate was 70.5%. The most common grade 3/4 toxicities were neutropenia (15.3%), asthenia (10.3%), diarrhea and mucositis (6.4% each). Dysphonia was reported in 39.7% of patients, and grade 3 hypertension in 3.8%. Development of hypertension (any grade) was significantly associated with a reduced risk of progression by multivariate analysis (HR = 2.7; 95%CI 1.3-5.4; P = 0.001). CONCLUSIONS: Efficacy with FOLFIRI-aflibercept in a real-life population was in line with results from the pivotal trial and toxicity was manageable with treatment adaptation. Survival outcomes were not impacted by primary tumour location, RAS-mutant status, first-line treatment or primary tumour surgery. Hypertension may be a surrogate marker of efficacy in this patient population.

Manejo del trauma penetrante de cuello en dos hospitales de Bogotá, Colombia / Management of penetrating neck trauma at two hospitals in Bogotá, Colombia

Introducción. El manejo del trauma penetrante de cuello en pacientes estables, según la zona de Monson lesionada, orienta la solicitud de pruebas diagnósticas para identificar lesiones vasculares, de las vías aéreas y del tubo digestivo. Materiales y métodos. Se trata de un estudio observacional, descriptivo y retrospectivo. Se incluyeron pacientes de 15 años o más con trauma penetrante de cuello, que consultaron a los dos hospitales de la Sociedad de Cirugía de Bogotá en un periodo de cinco a seis años. Se recolectó la información demográfica, clínica y de las pruebas diagnósticas practicadas, para determinar su utilidad. Las variables cualitativas se describieron con frecuencias relativas y absolutas, y las cuantitativas, con medias y desviaciones estándar. Resultados. Inicialmente, se incluyeron 148 pacientes, de los cuales 133 fueron catalogados como estables durante la valoración primaria, con un promedio de edad de 33,04 años (desviación estándar, DE=12,9); la mayoría (88,7 %) eran hombres. La mediana de la estancia hospitalaria fue de dos días (rango intercuartílico, RIQ=1-4 días). En la mayoría (117; 87,9 %) de los casos, la herida fue causada con arma cortopunzante. En casi todas las pruebas diagnósticas, se reportaron pocos hallazgos anormales, a excepción de la angiotomografía (angio-TC) que se practicó en 59 pacientes y demostró 43 resultados anormales. Se decidió tratamiento quirúrgico en siete pacientes catalogados como estables al ingreso y, en 14, por resultados anormales de las pruebas diagnósticas. Se presentaron cinco fallecimientos. Conclusión. El examen físico, la observación clínica y la angio-TC son suficientes para identificar lesiones vasculares, de la vía aérea o del tubo digestivo en los pacientes con trauma penetrante de cuello, en hospitales que no son considerados como especializados en trauma

Introduction: Management of penetrating neck trauma in stable patients according to the affected Monson zone directs the diagnostic tests to identify vascular, airway and digestive tract lesions. Materials and methods: A retrospective descriptive observational study was conducted. We included 15 year-old or older patients with penetrating neck trauma that consulted at the two hospitals of the Sociedad de Cirugía in Bogotá, Colombia, during a 5 to 6 year period. Demographic and clinical information was collected, as well as the results of the diagnostic tests applied in order to determine their utility. Qualitative variables were described with relative and absolute frequencies and quantitative variables with median and standard deviations. Results: 148 patients were enrolled initially, of which 133 were classified as stable during the primary assessment, with an average age of 33.04 years (SD: 12.9), the majority being men (88.7%). The median hospital stay was 2 days (IQR=1-4 days). The most frequent wound mechanism was a sharp bladed weapon in 117 cases (87.9%). A low proportion of abnormal findings were reported in the diagnostic tests, except for angiography CT which was performed in 59 patients with 43 with abnormal findings. Surgical management was defined for 7 patients classified as stable at admission and for 14 patients after abnormal findings found in the diagnostic tests. Five deaths were registered. Conclusion: Physical examination, clinical observation and angiography CT are sufficient to identify vascular, airway and digestive lesions in patients with penetrating neck trauma at hospitals that are not considered specialized in trauma

Factores predictores perioperatorios de complicaciones de la colecistectomía por laparoscopia / Perioperative complications predictive risk factors in laparoscopic cholecystectomy

Introducción. Los factores de riesgo para la conversión a laparotomía y las complicaciones de la colecistectomía laparoscópica se han estudiado, pero no se conocen modelos actuales de predicción para estos resultados. Objetivo. Desarrollar un modelo de predicción para las complicaciones de la colecistectomía laparoscópica. Pacientes y métodos. Se llevó a cabo un estudio analítico retrospectivo que incluyó 1.234 pacientes con colelitiasis sometidos a colecistectomía laparoscópica, en un periodo de 18 meses en un hospital de IV nivel de Colombia. Se hizo el análisis multivariado por medio de regresión logística, usando el procedimiento backward para selección de variables, buscando determinar la probabilidad en un punto compuesto de complicación (presencia de, al menos, una complicación: lesión de vía biliar, colección intraabdominal o sangrado). Se elaboró una curva ROC para determinar la capacidad predictiva del modelo y el análisis de datos se hizo en Stata 13™. Resultados. Los pacientes incluidos se clasificaron en cohortes de derivación (926) y de validación (308), y se encontró que el 69,2 % eran mujeres; la edad mediana fue de 48 años (RIC=34-60) y, la conversión, de 4,3 %; hubo colección intraabdominal en 2,6 % y complicaciones en 4,7 %, y la mortalidad global fue de 0,3 %. La edad, la diabetes mellitus, la enfermedad renal crónica, la coledocolitiasis y el síndrome de Mirizzi se identificaron como predictores de alguna complicación. La capacidad predictiva del modelo fue de 58 %. Conclusión. La probabilidad de alguna complicación perioperatoria de la colecistectomía por laparoscopia depende de la edad, la diabetes mellitus, la enfermedad renal crónica, la coledocolitiasis y el síndrome de Mirizzi. Los factores de riesgo y las complicaciones descritos aquí, pueden guiar nuevas investigaciones y proporcionar evaluación de riesgos específicos

Introduction. Risk factors associated with conversion from laparoscopic cholecystectomy to open surgery and its complications are well known. However, there are currently no prediction models for such outcomes. The objective of tis work was to devolop a prediction model for laparoscopic cholecystectomy complications. Materials and methods. This is a retrospective analytical study that included 1,234 patients who underwent laparoscopic cholecystectomy in an 18 months period at a fourth level of care hospital in Bogota, Colombia. A multivariable logistic regression analysis using backward procedure was performed to for the selection of variables, in order to determine the likelihood of a combined endpoint complication (presence of at least one of the complications: bile ducts injury, haemorrhage, organ/space surgical site infection). A ROC curve was performed to determine the predictive ability of the model; information analysis was performed in 13 STATA. Results. Patients were classified in a derivation (926) and a validation cohort (308). It was found that 69.2 % were female, median age 48 years (IQR 34-60 ), conversion rate 4.3%, organ/space surgical site infections 2.6%, combined end point complication 4.7%, and global mortality rate 0.3%. Diabetes mellitus (DM), chronic kidney disease (CKD), choledocholitiasis and Mirizzi´s syndrome were found as predictors of the occurrence of complications. The model was validated in the validation cohort, obtaining an area under the ROC curve of 58%. Discussion. The likelihood of major complication in laparoscopic cholecystectomy depends on age, DM, CKD, choledocholitiasis, and Mirizzi´s syndrome. Risk Factors and complications described here can guide a new research avenue and provide the evaluation of specific risks

Prognostic and predictive markers of response to treatment in patients with locally advanced unresectable and metastatic pancreatic adenocarcinoma treated with gemcitabine/nab-paclitaxel: Results of a retrospective analysis.

BACKGROUND: Recent studies support the use of gemcitabine and nab-paclitaxel in adults with locally advanced unresectable or metastatic pancreatic adenocarcinoma although insufficient data are available on prognostic and predictive markers of response to treatment. OBJECTIVE: The objective of this study is to identify treatment response markers in patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma. MATERIALS AND METHODS: This is an observational, retrospective, and multicenter study. Sociodemographic, clinical, and therapeutic data were collected. Cox regression models were applied to determine associations. RESULTS: In total, 39 patients were included; 23.1% presented locally advanced pancreatic cancer and 76.9% metastatic disease. They received a mean of 6 ± 3 treatment cycles; 59% required dose reduction, 59% treatment delay, and 20.5% switched to a biweekly regimen. The overall response rate was 23% and the disease control rate was 81%. Median progression-free survival was 9 months and median overall survival (OS) was 15 months. A higher neutrophil/lymphocyte ratio (NLR) was significantly associated with lower OS. We reported Grades 1-4 nonhematological and hematological toxicities. CONCLUSION: NLR is a useful prognostic factor for OS in patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma treated with gemcitabine and nab-paclitaxel. Moreover, we suggest that a biweekly regimen is an option for certain groups of patients.

Incidencia de falla anastomótica en intestino delgado, colon y recto, Bogotá, Colombia / Incidence of anastomotic failure in small bowel, colon and rectum, Bogotá, Colombia

Introducción. La falla anastomótica es una de las principales complicaciones de las cirugías gastrointestinales, que se presenta en 3,4 a 15 % de los pacientes, aproximadamente. En Colombia, no se conoce con exactitud la incidencia de falla anastomótica. Objetivo. Determinar la incidencia de falla anastomótica en cirugías intestinales en dos hospitales de IV nivel de Bogotá. Métodos. Se llevó a cabo un estudio prospectivo de cohorte que incluyó pacientes sometidos a anastamosis y a quienes se les hizo seguimiento hasta de 30 días. Se realizó un análisis descriptivo de la información, asociaciones entre variables mediante la prueba de ji al cuadrado y, además, se emplearon gráficas de KaplanMeier para determinar el tiempo hasta el evento. Los datos se analizaron en Stata 13®. Resultados. Se incluyeron 195 pacientes. El 47,1 % era de sexo masculino y la mediana de la edad fue de 60 años (rango intercuartílico, RIC: 48 a 70). La incidencia de falla anastomótica fue de 10,8 % y la tasa de incidencia fue de 10,2 por 1.000 personas/año. El 29,7 % de los pacientes presentaron complicaciones posoperatorias y se presentó una mortalidad de 9,7 %. La mediana de la estancia hospitalaria fue de 8 días (RIC: 5 a 16). Conclusiones. La incidencia de fístula de la anastomosis que se presentó estuvo acorde con lo reportado en la literatura científica a nivel mundial. El antecedente de cirugía abdominal así como la cirugía de urgencia fueron los factores frecuentes entre los pacientes que presentaron falla anastomótica

Introduction: Anastomotic leak is one of the main complications of patients submitted to gastrointestinal surgery. It occurs in approximately in 3.4% to 15% of cases. In Colombia the overall incidence of anastomotic leak is not known. Material and methods: A prospective cohort study that included patients undergoing anastamosis and who were followed up for up to 30 days. A descriptive analysis of the information was performed. The variables were analyzed with the chi-square test and the Kaplan-Meller graphs were used to determine the time to the event. Data analyses was performed on STATA 13. Results: 195 patients were admitted. 47.1% were male, and the median age of the study group was 60 years (ICR: 48-70). The incidence of anastomotic failure was 10.8% and the incidence rate was 10.2 per 1000 person-years; 29.7% of the patients presented postoperative complications and a mortality rate of 9.7%. The median hospital stay was 8 days (ICR: 5 - 16). Conclusion: The incidence of anastomotic leak observed appears in accordance with reports published in the world literature. The history of abdominal surgery as well as emergency surgery were the most frequent factors among the patients who developed anastomosis leak

Single port laparoscopic cholecystectomy in Situs Inversus Totalis / Colecistectomía laparoscópica de puerto único en Situs Inversus Totalis

Symptomatic cholelithiasis is a highly prevalent disease in Colombia, though its presentation in patients with situs inversus totalis has rarely been described. This report describes the case of a patient with symptomatic cholelithiasis and situs inversus totalis who underwent a single-port laparoscopic surgery after concomitant gallstones were ruled out. This procedure is a minimally invasive technique of SILS (Single Incision Laparoscopic Surgery). Situs Inversus is a rare genetic disorder which is characterized by the transposition of the abdominal and chest organs through the sagittal plane, having a so-called "mirror image" effect. While the etiology is still unclear, it is often attributed to a genetic predisposition caused by an autosomal recessive gene of incomplete penetrance. The presence of symptomatic vesicular lithiasis in a patient with SIT not only creates diagnostic doubt but also presents a real challenge for treatment as any surgical procedure (especially laparoscopic cholecystectomy) will be more difficult due to the anatomical abnormalities of the patient.

La colelitiasis sintomática es una enfermedad altamente prevalente en Colombia, aunque rara vez se ha descrito su presentación en pacientes con situs inversus totalis. Este informe describe el caso de un paciente con colelitiasis sintomática y situs inversus totalis que se sometió a una cirugía laparoscópica de puerto único después de descartar cálculos biliares concomitantes. Este procedimiento es una técnica mínimamente invasiva de SILS (cirugía laparoscópica de incisión única). Situs Inversus es un raro trastorno genético que se caracteriza por la transposición de los órganos abdominales y del tórax a través del plano sagital, teniendo el llamado efecto de "imagen especular". Si bien la etiología aún no está clara, a menudo se atribuye a una predisposición genética causada por un gen autosómico recesivo de penetración incompleta. La presencia de litiasis vesicular sintomática en un paciente con TIE no solo crea dudas diagnósticas sino que también presenta un desafío real para el tratamiento ya que cualquier procedimiento quirúrgico (especialmente la colecistectomía laparoscópica) será más difícil debido a las anormalidades anatómicas del paciente.

Phase II trial of erlotinib plus capecitabine as first-line treatment for metastatic pancreatic cancer (XELTA study).

AIM: To evaluate the efficacy and safety of erlotinib plus capecitabine for metastatic pancreatic cancer. PATIENTS AND METHODS: This was a multicenter, uncontrolled, phase II trial. Patients with untreated metastatic pancreatic cancer received oral capecitabine at 1,000 mg/m(2) twice daily on days 1-14, of a 21-day treatment cycle; and oral erlotinib at 150 mg daily. RESULTS: Thirty-two patients were enrolled. The overall response rate (ORR) was 6%, with a median time to treatment failure of 2.1 months. The median follow-up was 7.6 months. The median progression-free survival was 2.1 months and median overall survival was 4.3 months. The one-year survival rate was 22%. Major grade 1 and 2 non-hematological toxicities were skin rash (34%), asthenia (31%) and diarrhea (31%). Grade 3 hematological toxicity was <13%. No grade 4 toxicities were detected. None of the patients died due to treatment toxicity. CONCLUSION: The combination of capecitabine with erlotinib is an active regimen with a favorable safety profile for patients with metastatic pancreatic cancer.

Implicaciones clínicas y quirúrgicas de las variaciones anatómicas vasculares del riñón / Clinical and surgical implications of the anatomic variations of the renal vessels / Implicações clínicas cirúrgicas das variações anatômicas vasculares do rim

Introducción: Conocer y diagnosticar las variaciones más frecuentes de la vasculatura renal es de gran importancia para la planificación de la nefrectomía laparoscópica en el donante y para la reconstrucción vascular en el trasplante renal. De igual forma, considerar las variaciones vasculares -especialmente las del sistema venoso- es indispensable en reconstrucción vascular debido a la gran proporción de variaciones venosas asociadas a aneurismas de la aorta abdominal; además, es ideal en el estudio de condiciones clínicas tales como el síndrome de congestión pélvica y la hematuria. Metodología: Se trata de una revisión de la bibliografía sobre la proporción, diagnóstico, procedimientos quirúrgicos y síndromes clínicos asociados a las variaciones de la vasculatura renal, basada en el material encontrado con la siguiente estrategia de búsqueda: "Renal Artery/abnormalities"[Mesh] OR Renal Veins/abnormalities"[Mesh] AND "surgery"[Mesh] OR "transplantation"[Mesh] OR "radiography"[Mesh] "Kidney Pelvis/abnormalities"[Mesh] AND "Kidney Pelvis/blood supply"[Mesh]. Esta estrategia se modificó de acuerdo con las bases de datos: MEDLINE/PubMed, MEDLINE OVID, SCIENCEDIRECT, HINARI y LILACS. Desarrollo: Se revisó el origen y los tipos más frecuentes de variaciones de la vasculatura renal. Se investigó sobre las implicaciones quirúrgicas y los síndromes clínicos asociados.

Introduction: Precise knowledge of the most frequent types of renal vascular anatomical variations, as well as the adequate clinical evaluation is of great importance during laparoscopic donor nephrectomy and during renal vascular reconstruction using kidney allografts with multiple vessels. Equally important is to consider the venous anatomical variations during abdominal vascular reconstruction, particularly when performing an abdominal aortic aneurysm repair, because of the outstanding proportion of renal vascular variations that are associated with this pathology. In addition, it is ideal to think carefully about these variations when a pelvic congestion syndrome or hematuria diagnosis is encountered. Materials and methods: This paper reviews the incidence, diagnosis, surgical procedures, and clinical syndromes associated with renal anatomical vascular variations. We conducted this review taking into account the following Mesh terms: "Renal Artery/abnormalities"[Mesh] OR Renal Veins/abnormalities"[Mesh] AND "surgery"[Mesh] OR "ransplantation"[Mesh] OR "radiography"[Mesh] "Kidney Pelvis/abnormalities"[Mesh] AND "Kidney Pelvis/blood supply"[Mesh]. These terms were adapted with each of the database that was consulted: MEDLINE/PubMed, MEDLINE OVID, SCIENCEDIRECT, HINARI and LILACS. Development: The source and the most frequent types of the vascular anomalies of the kidney were reviewed. We investigated about the associated clinical syndromes and the surgical consequences in kidney transplant.

Introdução. Conhecer e diagnosticar as variações mais freqüentes da vasculatura renal é de grande importância para a planificação da nefrectomia laparoscópica no doador e para a reconstrução vascular no transplante renal. De igual forma, considerar as variações vasculares -especialmente as do sistema venoso- é indispensável em reconstrução vascular devido à grande proporção de variações venosas associadas a aneurismas da aorta abdominal; além disso, é ideal no estudo de condições clínicas tais como a síndrome de congestão pélvica e a hematúria. Metodologia. Trata-se de uma revisão da bibliografia sobre a proporção, diagnóstico, procedimentos cirúrgicos e síndromes clínicas associadas às variações da vasculatura renal, baseada no material encontrado com a seguinte estratégia de procura: "Renal Artery/abnormalities"[Mesh] OR Renal Veins/abnormalities"[Mesh] AND "surgery"[Mesh] OR "transplantation"[Mesh] OR "radiography"[Mesh] "Kidney Pelvis/ abnormalities"[Mesh] AND "Kidney Pelvis/blood supply"[Mesh]. Esta estratégia se modificou de acordo com as bases de dados: MEDLINE/PubMed, MEDLINE OVID, SCIENCEDIRECT, HINARI y LILACS. Desenvolvimento. Se revisou a origem e os tipos mais freqüentes de variações da vasculatura renal. Se investigou sobre as implicações cirúrgicas e as síndromes clínicas associadas.

Cetuximab given every 2 weeks plus irinotecan is an active and safe option for previously treated patients with metastatic colorectal cancer.

BACKGROUND: We gathered data from multiple institutions on the cetuximab regimen of patients with metastatic colorectal cancer. METHODS: 126 patients from 19 centers were included from July 2006 to July 2007 in this prospective non-controlled study. Irinotecan-refractory metastatic colorectal cancer patients with Karnofsky >or=70 received cetuximab 500 mg/m(2) every 2 weeks (q2w) in combination with irinotecan 180 mg/m(2) q2w until disease progression or unacceptable toxicity. The primary endpoint was the progression-free rate at 12 weeks. RESULTS: Median age was 65 years; 65.9% male; colon/rectum 64.3/34.1%; Karnofsky status or=90% in 45.3/54.7% of the patients. The progression-free rate was 42.7 (95% CI 32.8-52.6) and 22.4% (95% CI 14.2-30.7) at 12 and 24 weeks, respectively. The main grade 3 or 4 toxicities were: diarrhea 13.5% and acne-like rash 10.3%. No grade 3 or 4 infusional or allergic reactions were reported. CONCLUSIONS: The progression-free rates confirm that cetuximab q2w in combination with irinotecan is an option, and is as active and safe as the standard weekly regimen.

El síndrome de compresión biliar extrínseca benigna o síndrome de Mirizzi: experiencia de cinco años en el Hospital de San José / Syndrome of external biliary compression or Mirizzi's Syndrome: five-year experience at Hospital San José (Bogotá)

Introducción: el síndrome de compresión biliar extrínseca, o síndrome de Mirizzi, descrito por Pablo Mirizzi en 1948, es una entidad quirúrgica con baja incidencia que supone un reto quirúrgico en su diagnóstico y manejo.Materiales y métodos: estudio descriptivo, retrospectivo, de serie de casos en el que se informan los resultados de la revisión de las historias clínicas de 934 pacientes a quienes se les practicó colecistectomía en el Hospital de San José de 2001 a 2005. Se analizaron los datos epidemiológicos, los procedimientos quirúrgicos llevados a cabo, la morbilidad y la mortalidad de este grupo de pacientes manejado en un hospital de alta complejidad.Resultados: se revisaron las historias clínicas de 36 pacientes con síndrome de Mirizzi. Según la clasificación de A. Csendes, se encontraron 31 (86 porciento) con síndrome de Mirizzi tipo I, 1 (2,7 porciento) tipo II, 3 (8,3 porciento) tipo III y 1 (2,7 porciento) tipo IV, para una frecuencia de 3,85 porciento.Conclusión: la literatura mundial informa una frecuencia del síndrome de Mirizzi de 0,7 a 1,4 porciento mientras que en el Hospital de San José la prevalencia fue de 3,85porciento. Este es un centro de reconocido manejo de la patología biliar en el país, en donde los cirujanos adquieren un alto nivel de entrenamiento, lo cual hace poco probable la sobreestimación del concepto de Mirizzi.

Sobrevida del paciente y del injerto renal: receptores de trasplante renal en el Hospital de San José de 1996 a 2004 / Patient survival and renal graft: kidney transplant recipients at the Hospital of San José from 1996 to 2004

Es un estudio observacional descriptivo retrospectivo de los pacientes con falla renal terminal sometidos a trasplante renal en el Hospital de San José entre 1996 y 2004. Se analizaron las características clínicas y quirúrgicas y su relación con la sobrevida de los receptores y del injerto a cinco años, usando los métodos univariado, bivariado, de frecuencia y una curva de probabilidad de sobrevida. 110 pacientes recibieron un trasplante renal en el hospital durante este lapso y se obtuvo información de 102 de ellos. El promedio de edad fue 35.53 años con desviación estándar (DE) de 13.25 años, la distribución por género fue 53,9% de hombres y 46.1% mujeres. El tipo de donante fue vivo 13,7% y cadavérico 86,3%. Hubo una tasa de sobrevida de los receptores a cinco años del 86,28% (88 pacientes) y el 92,85% de las muertes ocurrieron en los dos primeros meses. La tasa de sobrevida del injerto a cinco años fue del 70% según los datos analizados en 85 pacientes. Consideramos que el retardo de la función del injerto, el rechazo agudo y la influencia del cambio en los esquemas inmunosupresores debe analizarse puntualmente. Además, se puede desarrollar un sistema de pareamiento de los injertos según la masa metabólica del paciente, la edad y la función previa entre donadores y receptores, para evaluar su influencia en la función del injerto.

Neo-adjuvant treatment of infiltrating transitional-cell carcinoma of the bladder with paclitaxel and cisplatin: a phase II trial.

BACKGROUND: A phase II multicentric trial of paclitaxel and cisplatin was conducted in previously untreated patients, with locally advanced transitional-cell carcinoma (TCC) of the bladder, to assess its toxicity and efficiency in preserving the bladder. METHODS: Forty-four patients with locally advanced TCC of the bladder (seven with T3a, 27 with T3b, and eight with T4a) were treated with paclitaxel 175 mg/m(2) over 3 h, and cisplatin 75 mg/m(2) over 30 min, on the first day of each 21-day treatment cycle. Therapy was continued for three cycles. Patients were re-evaluated and scheduled for radiotheraphy or radical surgery depending on tumoral response. Tumoral response was measured by citology, computed tomographical scans, and deep randomized biopsies of the bladder. RESULTS: Thirty-two out of 42 patients (76%; 95% confidence interval 45-93%) showed a major response (22 complete, and 10 partial). Response times ranged from 18 to 54 months. Three patients with T4 bladder primary tumors experienced a pathological CR. At a median follow-up of three years, 20 patients remain free of disease (47.6%), six patients are alive with disease (14.3%), 12 patients died of disease (28.5%), and four others died of unrelated causes (9.5%). Hematological toxicity included anemia, thrombocytopenia, and neutropenia. No grade four febrile neutropenia was observed. Non-hematological toxicity included alopecia (93.2%), diarrhea (11.4%), vomiting (18.5%) mucosytis (4.6%), and neuropathy (4.6%). Drug omissions or dose delay for adverse events were only necessary in one patient (2.2%), and three patients (6.8%), respectively. CONCLUSIONS: Paclitaxel and cisplatin is an active and well-tolerated neo-adjuvant regimen for previously untreated patients with pure TCC of the bladder, achieving a vesical preservation rate of 52%.