Acute Pancreatitis and Thrombosis (PATHRO)

Acute Necrotizing Pancreatitis Clinical Trial

— PATHRO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04642794
• Other study ID #: MR_PATHRO
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: November 2020
• Source: Nantes University Hospital
• Contact: GARRET Charlotte, MD
• Phone: 0240084737
• Email: charlotte.garret[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Necrotizing Pancreatitis
• Pancreatitis
• Pancreatitis, Acute Necrotizing
• Portosplenomesenteric Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of anticoagulation therapy	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	up to 12 months
Secondary	evaluate the outcomes of Number of patients admitted for AP with portosplenomesenteric vein thrombosis		up to 12 months
Secondary	hospital mortality at D28	evaluate the hospitality mortality at D28 of patients admitted for AP with portosplenomesenteric vein	Day 28
Secondary	hospital mortality at D90	evaluate the hospitality mortality at D90 of patients admitted for AP with portosplenomesenteric vein	Day 90
Secondary	hospital mortality at 6 months	evaluate the hospitality mortality at 6 months of patients admitted for AP with portosplenomesenteric vein	6 months
Secondary	hospital mortality at 12 months	evaluate the hospitality mortality at 12 months of patients admitted for AP with portosplenomesenteric vein	12 months
Secondary	incidence of portal cavernoma	evaluate the incidence of portal cavernoma of patients admitted for AP with portosplenomesenteric vein	up to 12 months
Secondary	incidence of type 2 diabetes secondary to AP	evaluate the incidence of type 2 diabetes secondary to AP of patients admitted for AP with portosplenomesenteric vein	up to 12 months
Secondary	incidence of occurrence of malabsorption	evaluate the incidence of occurrence of malabsorption of patients admitted for AP with portosplenomesenteric vein	up to 12 months
Secondary	incidence of digestive ischemia	evaluate the incidence of digestive ischemia of patients admitted for AP with portosplenomesenteric vein	up to 12 months
Secondary	incidence of hepatic ischemia	evaluate the incidence of hepatic ischemia of patients admitted for AP with portosplenomesenteric vein	up to 12 months
Secondary	incidence of pancreatic necrosis	evaluate the incidence of pancreatic necrosis of patients admitted for AP with portosplenomesenteric vein	up to 12 months