Clinical trial NCT04642794: Acute Pancreatitis and Thrombosis (PATHRO)
Official title: Management of Portoplenomesenteric Vein Thrombosis in Patients With Acute Pancreatitis : an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Necrotizing Pancreatitis
Portosplenomesenteric Venous Thrombosis
Keywords: acute necrotizing pancreatitis
acute pancreatitis
pancreas disease
anticoagulation
anticolagulant therapy
bleeding
Portosplenomesenteric Vein Thrombosis
splanchic venous thrombosis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients admitted for AP with portosplenomesenteric vein thrombosis

Brief summary: Severe acute pancreatitis (AP) is a pathology with high morbidity and mortality. Portosplenomesenteric vein thrombosis is a well-known local complication of AP with a variable incidence, which can reach up to 50% in case of severe AP. However, there is no specific recommendation regarding the management of Portosplenomesenteric vein thrombosis. By analogy to all venous thrombosis, the European Society of Gastroenterology recommends curative anticoagulation. However, the efficacy of curative anticoagulation has never been evaluated by prospective studies. In addition, bleeding complications during AP occur in approximately 10% of patients and are associated with a poor prognosis.

The investigators wish to conduct an observational multi-center study with epidemiologic aims, including all patients admitted for AP and with a diagnosis of portosplenomesenteric vein thrombosis. The aim of this study is to evaluate the therapeutic management of these patients, the efficacy and safety of anticoagulant treatment for the treatment of Portosplenomesenteric vein thrombosis, and their outcomes.

Detailed description: The investigators will include prospectively all patients admitted for AP with a computed tomography diagnosis of portosplenomesenteric vein thrombosis.

Eligibility criteria: Inclusion Criteria:

* Adult Patients (age \> 18 years) with acute pancreatitis
* AND a diagnosis on CT injected with portal time of portosplenomesenteric vein thrombosis or laminated veins (without passage of blood flow through the vessel but without visible intraluminal thrombus) will be included.

Exclusion Criteria:

* Patient under guardianship
* Refusal to participate in research
* Pregnancy

Primary outcomes:
measure: incidence of anticoagulation therapy
timeFrame: up to 12 months
Secondary outcomes:
measure: evaluate the outcomes of Number of patients admitted for AP with portosplenomesenteric vein thrombosis
timeFrame: up to 12 months
measure: hospital mortality at D28
timeFrame: Day 28
measure: hospital mortality at D90
timeFrame: Day 90
measure: hospital mortality at 6 months
timeFrame: 6 months
measure: hospital mortality at 12 months
timeFrame: 12 months
measure: incidence of portal cavernoma
timeFrame: up to 12 months
measure: incidence of type 2 diabetes secondary to AP
timeFrame: up to 12 months
measure: incidence of occurrence of malabsorption
timeFrame: up to 12 months
measure: incidence of digestive ischemia
timeFrame: up to 12 months
measure: incidence of hepatic ischemia
timeFrame: up to 12 months
measure: incidence of pancreatic necrosis
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: University hospital of Nantes
name: GARRET Charlotte, MD
role: PRINCIPAL_INVESTIGATOR
References: