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Acute Pancreatitis and Thrombosis (PATHRO) (PATHRO)

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ClinicalTrials.gov Identifier: NCT04642794
Recruitment Status : Not yet recruiting
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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
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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Management of Portoplenomesenteric Vein Thrombosis in Patients With Acute Pancreatitis : an Observational Study
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients admitted for AP with portosplenomesenteric vein thrombosis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642794


Contacts
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Contact: GARRET Charlotte, MD 0240084737 charlotte.garret@chu-nantes.fr

Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: GARRET Charlotte, MD University hospital of Nantes
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04642794    
Other Study ID Numbers: MR_PATHRO
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
acute necrotizing pancreatitis
acute pancreatitis
pancreas disease
anticoagulation
anticolagulant therapy
bleeding
Portosplenomesenteric Vein Thrombosis
splanchic venous thrombosis
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Acute Necrotizing
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Pancreatic Diseases
Digestive System Diseases