HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma.

BACKGROUND: Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). METHODS/DESIGN: The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42-43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. DISCUSSION: We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. TRIAL REGISTRATION: NCT02614534 ( clinicaltrial.gov ) Nov-2015.

[Clinical and demographic characteristics of the cases of dementia diagnosed in the Health District of Girona throughout the period 2007-2010: data from the Girona Dementia Registry (ReDeGi)]. / Caracteristicas clinicas y demograficas de los casos de demencia diagnosticados en la Region Sanitaria de Girona durante el periodo 2007-2010: datos del Registro de Demencias de Girona (ReDeGi).

INTRODUCTION: The Girona Dementia Registry (ReDeGi, from Spanish: Registro de Demencias de Girona) is a population-based epidemiological surveillance mechanism that registers the cases of dementia diagnosed by the reference centres in the Girona Health District. AIM: To report on the frequency of the diagnoses and their clinical and sociodemographic characteristics, as well as to compare differences depending on the different subtypes of dementia. PATIENTS AND METHODS: The method used consisted in a consecutive standardised register of the diagnoses involving dementia in specialised procedures in the Girona Health District between 2007 and 2010. RESULTS: A total of 2814 cases were registered, which represents a clinical incidence of 6.6 cases per 1000 persons/year. Of this total number, 69.2% were primary degenerative dementias, 18.9% were dementias secondary to a vascular pathology, 5.4% were other secondary dementias and 6.5% were non-specific dementias. The mean age was 79.2 ± 7.6 years (range: 33-99 years) and 59.3% were females. The mean time elapsed since the onset of symptoms and clinical diagnosis was 2.5 ± 1.7 years. The mean score on the Blessed dementia scale was 7.7 ± 4.5 points and in the minimental test it was 17.6 ± 5.4 points. A family history of dementia was present in 26.6% of cases and 69.6% presented one or more cardiovascular risk factors. In 60.6% of cases they were cases of mild dementia, 28.5% were moderate and 10.9% were severe cases. CONCLUSIONS: The epidemiological surveillance activity carried out by the ReDeGi throughout the period 2007-2010 has made it possible to record information that is extremely valuable for the planning and management of health care resources.

[Hyperammonemic encephalopathy associated with valproate acid]. / Encefalopatía hiperamoniémica asociada al uso de valproato sódico.

We report 4 clinical cases of hyperammonemic encephalopathy (HE) associated with valproate acid (VPA) and review the literature on its pathophysiology. In all four cases, hepatic function was normal and valproic levels were within the therapeutic range. Elevated ammonium levels were found as the only biochemical abnormality. Patients showed decreased level of consciousness, confusion, ataxia and seizures. In 1 case the EEG showed diffused triphasic waves with frontal predominance. After suppression of treatment with VPA there was remission of clinical manifestations, and ammonium levels returned to normal. In order to obtain the correct diagnosis of HE, in all patients treated with either VPA mono or polytherapy, ammonium levels should be considered.

[Infiltration of the optic nerve by lymphoma. Diagnosis by magnetic resonance imaging]. / Infiltración del nervio óptico por linfoma. Diagnóstico por resonancia magnética.

INTRODUCTION: Systemic lymphoma with meningeal involvement is frequent and diagnosis is based on the clinical features, the study of the cerebrospinal fluid and evaluation by magnetic resonance imaging (MRI). Lymphoma with involvement of the orbitary region is more frequent in the optic nerve (ON) than of the eye itself. CLINICAL CASE: We report the case of a patient with diffuse non Hodgkin gastric lymphoma of the large B cell type, which coursed with amaurosis, exophthalmus and signs of tumorous meningeal involvement. The ophthalmologic study revealed a thrombosis in the central retinal vein. The MRI exploration only showed an infiltration of the ON with no pathological meningeal enhancement. ON involvement consisted in a peripheral enhancement of the sheath with obliteration of the subarachnoid space. This pattern accounts for the existence of an ischemic neuropathy by direct compression over the central retinal vein and artery. There are different anatomopathologic or ophthalmologic studies of neuropathy of the ON by lymphoma in the literature, but there is only one case of diagnosis by MRI. CONCLUSIONS: ON involvement can be the only radiological sign in cases of neoplastic tumours with meningeal involvement. The radiological pattern consists in a peripheral infiltration of the sheath of the ON.

[False negative diffusion in acute ischemic stroke]. / Difusión falsamente negativa en el ictus vertebrobasilar agudo.

INTRODUCTION: The new techniques of magnetic resonance imaging have produced a important advance in the early diagnosis of acute ischemic stroke. The diffusion weighted imaging (DWI) has a high sensitivity and specificity in the acute ischemia. CASE REPORT: 70 years old woman with previous history of hypertension and dyslipemia. The patient presented sudden vertigo with cervical neck pain and gaze problems. The physical exploration revealed right miosis, nistagmus, IX and X cranial nerve affection and ataxia. The clinical diagnosis was Wallenberg s syndrome and a medulla lateral infarction. However DWI was normal (10 hours). The neurological deficit was persistent and a repeated study disclosed a lateral infarction of the medulla. CONCLUSIONS: The sensitivity of DWI is reduced during the first 24 hours. There are false negative diagnosis mainly in small infarctions of posterior territory.