Clinical Research Directory

Coeliac Artery Release or Sham Operation

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.

Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic 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.

Cohort SURVI : Intestinal Ischemia and Vascular 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.