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NCT Number: NCT04642794

Acute Pancreatitis and Thrombosis (PATHRO)

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.

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Key information

Conditions

Acute Necrotizing Pancreatitis Digestive System Diseases Hemorrhage Pancreatic Diseases Pancreatitis Pancreatitis, Acute Necrotizing Pathologic Processes Pathological Conditions, Signs and Symptoms Portosplenomesenteric Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

patients admitted for AP with portosplenomesenteric vein thrombosis.

Primary outcomes

  1. 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 outcomes

  1. evaluate the outcomes of Number of patients admitted for AP with portosplenomesenteric vein thrombosis

    Time frame: up to 12 months

  2. hospital mortality at D28

    Time frame: Day 28

    evaluate the hospitality mortality at D28 of patients admitted for AP with portosplenomesenteric vein

  3. hospital mortality at D90

    Time frame: Day 90

    evaluate the hospitality mortality at D90 of patients admitted for AP with portosplenomesenteric vein

  4. hospital mortality at 6 months

    Time frame: 6 months

    evaluate the hospitality mortality at 6 months of patients admitted for AP with portosplenomesenteric vein

  5. hospital mortality at 12 months

    Time frame: 12 months

    evaluate the hospitality mortality at 12 months of patients admitted for AP with portosplenomesenteric vein

  6. incidence of portal cavernoma

    Time frame: up to 12 months

    evaluate the incidence of portal cavernoma of patients admitted for AP with portosplenomesenteric vein

  7. 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

  8. 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

  9. incidence of digestive ischemia

    Time frame: up to 12 months

    evaluate the incidence of digestive ischemia of patients admitted for AP with portosplenomesenteric vein

  10. incidence of hepatic ischemia

    Time frame: up to 12 months

    evaluate the incidence of hepatic ischemia of patients admitted for AP with portosplenomesenteric vein

  11. incidence of pancreatic necrosis

    Time frame: up to 12 months

    evaluate the incidence of pancreatic necrosis of patients admitted for AP with portosplenomesenteric vein

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: PATHRO

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2020
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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