Acute Pancreatitis and Thrombosis (PATHRO) (PATHRO)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Necrotizing Pancreatitis; Portosplenomesenteric Venous Thrombosis
• Intervention / Treatment: Other: observational study

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients admitted for AP with portosplenomesenteric vein thrombosis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: GARRET Charlotte, MD, University Hospital of Nantes

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: bleeding; anticoagulation; acute pancreatitis; acute necrotizing pancreatitis; pancreas disease; anticolagulant therapy; Portosplenomesenteric Vein Thrombosis; splanchic venous thrombosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Pancreatic Diseases; Thrombosis; Venous Thrombosis; Pancreatitis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: MR_PATHRO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No