Active clinical trials for "Mesenteric Ischemia"

Chronic mesenteric ischemia (CMI) is often caused by narrowings in the arteries providing blood to the intestines. Endovascular stent placement is considered the preferred treatment for this condition. Guidelines increasingly support the use of so called covered stents (CS) in stead of bare stents (BMS) for this use but the level of evidence for this is limited. Using CS incur additional costs for healthcare short-term but may prevent recurrence of narrowing and symptoms postoperatively benefitting patients and healthcare. Study Objective: To evaluate the outcomes after stenting of mesenteric arteries using BMS or CS. Study Outcome: Primary stent patency 1 year after placement The trial will also evaluate complications, how often stents need to be reoperated, Quality of Life (QoL) and reasons for subjects death Method: This is a so called prospective, randomized controlled trial comparing CS vs. BMS. This means that one patients have agrred to treatment they will be randomly selected for treatment with either CS or BMS . The stent metal structure is identical in the two implants and the only difference is the graft covering, making this study unique. The study will also collect blood samples for a biobank that will be used to study markers of disease and how these effect treatment outcomes. All patients referred to the Department of Vascular Surgery due to CMI are considered for inclusion if they havechronic symptoms consistent with CMI, significant stenosis or occlusion of the superior mesenteric artery and are > 18 years Subjects not able to provide informed consent or who have non atherosclerotic cause of CMI, signs of acute loss of blood flow to the intestines cannot participate. Previous stent treatment in the superior mesenteric artery, pregnancy, allergies to contrast or stent materials are also reasons for not being included in this trial. Side effects, risks and disadvantages for participants The risk for procedure-related complications is less than 5% and similar in both study groups. Most short-term complications are related to vascular access sites and consist of local bleeding and thrombosis. Other potential complications include impaired renal function due to contrast use, contrast allergy, arterial dissection and death.

Chronic Mesenteric Ischemia (CMI) is defined by one or more arterial digestive lesions, responsible for severe mesenteric symptoms. The clinical presentation of CMI is characterized by postprandial abdominal pain and weight loss, leading to severe malnutrition. It is a frequent pathology which affects preferentially the elderly patients of female sex (70%) with cardio-vascular comorbidities. Risk factors include smoking, hypertension, and dyslipidemia. Despite medical and diagnostic advances, the morbidity and mortality of CMI remain very high (>70%). Optimal management of CMI is based on early diagnosis. Symptomatic patients with CMI should be treated without much delay to relief symptoms (present in 43% patients) and prevent acute mesenteric ischemia. The three visceral arteries affected by atherosclerotic disease are coeliac trunc, inferior mesenteric artery and Superior Mesenteric Artery (SMA). The SMA is treated the most frequently, because it is the main relevant artery associated with CMI. Endovascular treatment (angioplasty and stenting) is considered as the first-line treatment for CMI when feasible. It is indicated especially in the case of high grade stenosis or occlusion of the Superior Mesenteric Artery. Two types of stents can be used for this procedure: bare metal stents (BMS) or covered stents (CS). Even if BMS are standard care there is no consensus on the type of stent to use. There are very few reported series with large numbers of patients comparing BMS and CS in this indication. However, to our knowledge, no results from a randomized study addressing this issue have ever been published. These are only retrospective with a low level of evidence (IIb). The largest series compared 147 patients with primary intervention for CMI treatment using BMS versus 42 using CS. Treatment with CS showed better results in terms of symptom recurrence (10% vs 32%, p <0.002), restenosis (12% vs 42%, p <0.0002) and re-interventions (10% vs 42%), after at least 1 year of follow-up. Indeed, endovascular treatment using BMS was associated with high incidence of symptoms recurrence despite the satisfying patency rates in both occluded and stenotic vessels. There are no international guidelines to recommend the use of one or another sort of stent. The necessity of a randomised study addressing the issue of bare metal versus covered stents deployment seems to be important. The investigators propose to demonstrate that covered stents presents a better efficacy than bare metal stents, with a multicenter randomized study involving 24 vascular surgical departments of French University Hospitals.

Ischemic bowel disease, also known as ischemic bowel disease (IBD), is a type of disease that causes the blood supply to a certain intestinal segment to be reduced or stopped by various reasons such as hypovolemia, shock or recent abdominal surgery, resulting in insufficient blood supply to the intestinal wall, and causing a series of pathological changes in the intestine. Human umbilical cord blood mononuclear cells (HUCB-MNC) can be economically and conveniently isolated from human cord blood. The HUCB-MNC obtained from the isolation of human umbilical cord blood contains a variety of stem cells, such as hematopoietic stem cells, endothelial stem cells, etc. A number of previous studies have confirmed that HUCB-MNC can improve the occurrence of ischemic bowel disease through immunomodulatory and tissue repair. These characteristics make HUCB-MNC a cell with great potential to treat ischemic diseases.

The first Intestinal Vascular Emergency Unit (SURVI), with the institutional support of AP-HP, opened on 4 January 2016, within the Paris-Nord Val de Seine University Hospital Group. This intensive care is dedicated to the management of mesenteric ischemias (acute mesenteric ischemias, chronic mesenteric ischemias) and Intestinal Vascular Diseases Without Ischemia. The organisation of this type of dedicated centre, combining advances in resuscitation, interventional radiology and knowledge of intestinal vascular diseases, has led to a radical change in the prognosis for acute mesenteric ischaemia with a survival rate of over 80% and an intestinal resection rate of less than 40%. Acute mesenteric ischaemia (AMI) is characterised by the combination of digestive distress and vascular insufficiency: occlusive (thrombosis, embolism, arterial, venous) or non-occlusive (low flow or vasospasm). The vital prognosis is catastrophic in the absence of treatment (the mortality rate of an intestinal infarction is almost 100% without treatment), and the functional and anatomical after-effects are major for the survivors. Many intestinal vascular diseases have been identified as providing acute and chronic mesenteric ischaemia. The nosological framework of these diseases is broad, ranging from constitutional diseases of the vessels (collagenosis, arcuate ligament syndrome) to acquired diseases of a thrombophilic, cardiac, degenerative, autoimmune, iatrogenic, traumatic nature... The rarity of these diseases (with the exception of atherosclerotic disease, the incidence of which is increasing with the ageing of the population) makes their level of knowledge insufficient. The natural history of vascular diseases without ischaemia (rate of acute and chronic mesenteric ischaemia, mortality rate, resection rate...) is currently not described. The construction of a longitudinal observational cohort is necessary for the prevalence of ischaemic complications and predictive factors.

Rationale: Acute intestinal ischemia is a life-threatening condition with a short-term mortality that can range up to 80%. Medical diagnosis and treatment have remained troublesome, due to the clinical presentation which is mostly characterized by non-specific signs and symptoms. Early unambiguous diagnosis of acute intestinal ischemia is critical to prevent progression from reversible to irreversible intestinal injury, and henceforth decrease morbidity and improve survival. Objective: We aim to validate a panel of plasma biomarkers and investigate volatile biomarkers that allow early and accurate identification of acute intestinal ischemia in patients. In addition, we aim to identify a volatile organic compound (VOC) profile specific for acute intestinal ischemia in exhaled breath. Study design: Prospective observational study Study population: All patients suspected of acute intestinal ischemia Main study parameters: The primary endpoint of the study is the early and accurate identification of presence and severity of acute intestinal ischemia in patients. The main study parameters are plasma biomarkers indicative for intestinal damage and volatile organic compounds (VOC) in exhaled air of patients suspected of acute intestinal ischemia. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is a minimal amount of risks involved in participating in this study. Blood samples will be obtained with the use of an arterial line, intravenous line (IV), central venous catheter (CVC), peripheral venous catheter (PVC) or a venepuncture. The risk of venepuncture is a small local hematoma. In addition to blood sampling, we will also obtain exhaled air. This non-invasive procedure takes approximately 5 minutes in which patients breath in a 3L Tedlar bag at a normal frequency and volume. This procedure will not cause any physical strain. Collection of samples and data will take place during the hospital stay of the included patients. For this reason, no additional hospital visits are required for this study. Participating patients in this study will have no direct benefits, but in the future the results of our study will likely be useful in the early diagnosis of patients suspected of acute intestinal ischemia. The research goal in this study is the early identification of patients that suffer from acute intestinal ischemia. These patients are difficult to diagnose due to a multitude of non-specific symptoms and the lack of fast and specific tests. In this study we will be able to investigate patients that are admitted with acute abdominal complications and observe them in the early stages of their condition. Accordingly, we will be able to evaluate the proposed panel of biomarkers and to identify VOC patterns in patients with acute abdominal complications.

In patients with Median Arcuate Ligament Syndrome (MALS), significant external compression of the coeliac artery (CA) by the median arcuate ligament (MAL) increasing mucosal ischemia (1,2) is assumed to cause chronic disabling postprandial abdominal pain, weight loss, and consequently lethargy and social deprivation (3,8). The majority of these patients have had a long medical journey before the diagnosis MALS is considered resulting in a substantial burden of disease and high healthcare and societal costs. Although a Systematic Review have shown a sustainable symptom relief of 68% and a significant and durable improvement of quality of life after surgical treatment for MALS (4), there is still no (inter)national consensus on the existence and treatment of MALS (1, 5, 6, 7). Two recent guidelines (3, 8) concluded that patients with MALS might be considered for surgical CA release (Recommendation 25 GRADE 2D; expert agreement 96%, Terlouw 2020). To end the ongoing debate and to enable the development of evidence-based guidelines for the management of MALS, both guideline committees recommend to perform a blinded, randomised controlled trial comparing a CA release with a sham operation. The proposed Coeliac Artery Release or Sham Operation study will either underline the usefulness of eCAR as a minimal invasive (cost)effective treatment for MALS or it will prohibit a meaningless intervention in patients with disabling abdominal symptoms. If the CARoSO study proves that the treatment of MALS by eCAR is effective, to 490 patients with chronic disabling abdominal symptoms per year can be treated in the Netherlands. Effective treatment of MALS is expected to result in mean health gain of 6.05 Quality Adjusted Life Years (QALYs)/patient and has the potency to reduce the substantial productivity loss and healthcare consumption caused by MALS, resulting in a saving up to M€4.3/year. The outcome of the CARoSO study will be translated into strong recommendations in the coming updates of the relevant (inter)national multidisciplinary guidelines and will be adapted in daily practice.

The aim of this study is to investigate the effect of early, supplementary parenteral nutrition following emergency laparotomy. Currently, parenteral nutrition is used in postoperative patients if or when oral or enteral nutrition is not feasible. However, little data exists on the optimal timing of parenteral nutrition. Oral and enteral nutrition is encouraged. Participants will randomized on the second postoperative day if their calorie intake (oral + enteral) is below 30% of the calculated requirement. Patients will be randomized to early (postoperative day 2) or postponed (postoperative day 5) start of parenteral nutrition. The combined oral + enteral + parenteral calorie target is 70-80% of the calculated requirement. Participants in the postponed group will be re-assessed on postoperative day 5, and if their calorie intake is less than 50% parenteral nutrition will be administered. The intervention will continue until oral + enteral intake is at least 70% of the calculated requirement or the participant is at his/her habitual intake.

ECMO has been used to save the lives of many critically ill patients with cardiorespiratory dysfunction as important rescue therapy. Though the proportion of ECMO applied to this population has been increasing year by year, clinical outcomes of AMI remain poor with high in-hospital mortality. Thus, it is necessary to characterize clinical features and investigate potentially modifiable factors contributing to outcomes of AMI patients who received ECMO treatment.

Multicenter, prospective, observational research project on children aged from 10 to 15 years old undergoing abdominal ultrasound examinations during routine clinical practice.

Patients suspected of chronic mesenteric ischemia shall be investigated with gastroscopy-assisted laser Doppler flowmeter and light spectroscopy (GALS).