Acute Pancreatitis and Thrombosis (PATHRO)

Sponsor

Nantes University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04642794

Collaborator

(none)

120

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Necrotizing Pancreatitis Portosplenomesenteric Venous Thrombosis	Other: observational study

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Management of Portoplenomesenteric Vein Thrombosis in Patients With Acute Pancreatitis : an Observational Study

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Outcome Measures

Primary Outcome Measures

incidence of anticoagulation therapy [up to 12 months]
incidence defined as : the ratio of the number of patients on curative anticoagulant therapy to the number of patients admitted with AP and portosplenomesenteric vein thrombosis during the inclusion period

Secondary Outcome Measures

evaluate the outcomes of Number of patients admitted for AP with portosplenomesenteric vein thrombosis [up to 12 months]
hospital mortality at D28 [Day 28]
evaluate the hospitality mortality at D28 of patients admitted for AP with portosplenomesenteric vein
hospital mortality at D90 [Day 90]
evaluate the hospitality mortality at D90 of patients admitted for AP with portosplenomesenteric vein
hospital mortality at 6 months [6 months]
evaluate the hospitality mortality at 6 months of patients admitted for AP with portosplenomesenteric vein
hospital mortality at 12 months [12 months]
evaluate the hospitality mortality at 12 months of patients admitted for AP with portosplenomesenteric vein
incidence of portal cavernoma [up to 12 months]
evaluate the incidence of portal cavernoma of patients admitted for AP with portosplenomesenteric vein
incidence of type 2 diabetes secondary to AP [up to 12 months]
evaluate the incidence of type 2 diabetes secondary to AP of patients admitted for AP with portosplenomesenteric vein
incidence of occurrence of malabsorption [up to 12 months]
evaluate the incidence of occurrence of malabsorption of patients admitted for AP with portosplenomesenteric vein
incidence of digestive ischemia [up to 12 months]
evaluate the incidence of digestive ischemia of patients admitted for AP with portosplenomesenteric vein
incidence of hepatic ischemia [up to 12 months]
evaluate the incidence of hepatic ischemia of patients admitted for AP with portosplenomesenteric vein
incidence of pancreatic necrosis [up to 12 months]
evaluate the incidence of pancreatic necrosis of patients admitted for AP with portosplenomesenteric vein

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.