Acute Pancreatitis and Thrombosis (PATHRO)

Overview

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.

Full Title of Study: “Management of Portoplenomesenteric Vein Thrombosis in Patients With Acute Pancreatitis : an Observational Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 1, 2023

Detailed Description

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

Interventions

  • Other: observational study
    • patients admitted for AP with portosplenomesenteric vein thrombosis.

Clinical Trial Outcome Measures

Primary Measures

  • incidence of anticoagulation therapy
    • Time Frame: 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 Measures

  • evaluate the outcomes of Number of patients admitted for AP with portosplenomesenteric vein thrombosis
    • Time Frame: up to 12 months
  • hospital mortality at D28
    • Time Frame: Day 28
    • evaluate the hospitality mortality at D28 of patients admitted for AP with portosplenomesenteric vein
  • hospital mortality at D90
    • Time Frame: Day 90
    • evaluate the hospitality mortality at D90 of patients admitted for AP with portosplenomesenteric vein
  • hospital mortality at 6 months
    • Time Frame: 6 months
    • evaluate the hospitality mortality at 6 months of patients admitted for AP with portosplenomesenteric vein
  • hospital mortality at 12 months
    • Time Frame: 12 months
    • evaluate the hospitality mortality at 12 months of patients admitted for AP with portosplenomesenteric vein
  • incidence of portal cavernoma
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: up to 12 months
    • evaluate the incidence of occurrence of malabsorption of patients admitted for AP with portosplenomesenteric vein
  • incidence of digestive ischemia
    • Time Frame: up to 12 months
    • evaluate the incidence of digestive ischemia of patients admitted for AP with portosplenomesenteric vein
  • incidence of hepatic ischemia
    • Time Frame: up to 12 months
    • evaluate the incidence of hepatic ischemia of patients admitted for AP with portosplenomesenteric vein
  • incidence of pancreatic necrosis
    • Time Frame: up to 12 months
    • evaluate the incidence of pancreatic necrosis of patients admitted for AP with portosplenomesenteric vein

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nantes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GARRET Charlotte, MD, Principal Investigator, University hospital of Nantes
  • Overall Contact(s)
    • GARRET Charlotte, MD, 0240084737, charlotte.garret@chu-nantes.fr

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