French university hospital trust starts a clinical trial of Intestinal Ischemia and Vascular Diseases
Photo by Pierre Acobas
Assistance Publique - Hôpitaux de Paris is starting a new clinical trial of 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 etc.) is currently not described.
The clinical trial started in November 27, 2020 and will continue throughout January 4, 2041.
Vascular Diseases (IIVD) will be primary outcome measure.
The excluding conditions are:
- Left ischaemic colitis without damage to the celiac trunk and/or superior mesenteric artery.
- Dissection of the abdominal aorta without intestinal ischaemia.
- Portal thrombosis without extension to the superior mesenteric vein.
- Portal thrombosis without extension to the superior mesenteric vein.
- Traumatic rupture of the digestive arteries.
- Non-injected abdominal scanner or no abdominal scanner.
The contacts and locations are the Olivier CORCOS, Clichy, France.
For more details: https://ichgcp.net/clinical-trials-registry/NCT04746534
