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Acute Pancreatitis and Thrombosis (PATHRO)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04642794
Acronym
PATHRO
Enrollment
51
Registered
2020-11-24
Start date
2020-11-01
Completion date
2022-07-15
Last updated
2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERobservational study

patients admitted for AP with portosplenomesenteric vein thrombosis.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of anticoagulation therapyup to 12 monthsincidence 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

MeasureTime frameDescription
hospital mortality at D28Day 28evaluate the hospitality mortality at D28 of patients admitted for AP with portosplenomesenteric vein
hospital mortality at D90Day 90evaluate the hospitality mortality at D90 of patients admitted for AP with portosplenomesenteric vein
hospital mortality at 6 months6 monthsevaluate the hospitality mortality at 6 months of patients admitted for AP with portosplenomesenteric vein
hospital mortality at 12 months12 monthsevaluate the hospitality mortality at 12 months of patients admitted for AP with portosplenomesenteric vein
incidence of portal cavernomaup to 12 monthsevaluate the incidence of portal cavernoma of patients admitted for AP with portosplenomesenteric vein
evaluate the outcomes of Number of patients admitted for AP with portosplenomesenteric vein thrombosisup to 12 months
incidence of occurrence of malabsorptionup to 12 monthsevaluate the incidence of occurrence of malabsorption of patients admitted for AP with portosplenomesenteric vein
incidence of digestive ischemiaup to 12 monthsevaluate the incidence of digestive ischemia of patients admitted for AP with portosplenomesenteric vein
incidence of hepatic ischemiaup to 12 monthsevaluate the incidence of hepatic ischemia of patients admitted for AP with portosplenomesenteric vein
incidence of pancreatic necrosisup to 12 monthsevaluate the incidence of pancreatic necrosis of patients admitted for AP with portosplenomesenteric vein
incidence of type 2 diabetes secondary to APup to 12 monthsevaluate the incidence of type 2 diabetes secondary to AP of patients admitted for AP with portosplenomesenteric vein

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026