Acute Pancreatitis and Thrombosis (PATHRO)

Completed

• Conditions: Acute Necrotizing Pancreatitis; Portosplenomesenteric Venous Thrombosis

• Registration Number: NCT04642794
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-11-24
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of anticoagulation therapy	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

Name	Time	Method
hospital mortality at 12 months	12 months	evaluate the hospitality mortality at 12 months of patients admitted for AP with portosplenomesenteric vein
incidence of hepatic ischemia	up to 12 months	evaluate the incidence of hepatic ischemia of patients admitted for AP with portosplenomesenteric vein
evaluate the outcomes of Number of patients admitted for AP with portosplenomesenteric vein thrombosis	up to 12 months
incidence of occurrence of malabsorption	up to 12 months	evaluate the incidence of occurrence of malabsorption of patients admitted for AP with portosplenomesenteric vein
incidence of digestive ischemia	up to 12 months	evaluate the incidence of digestive ischemia of patients admitted for AP with portosplenomesenteric vein
incidence of pancreatic necrosis	up to 12 months	evaluate the incidence of pancreatic necrosis of patients admitted for AP with portosplenomesenteric vein
hospital mortality at 6 months	6 months	evaluate the hospitality mortality at 6 months of patients admitted for AP with portosplenomesenteric vein
incidence of portal cavernoma	up to 12 months	evaluate the incidence of portal cavernoma of patients admitted for AP with portosplenomesenteric vein
incidence of type 2 diabetes secondary to AP	up to 12 months	evaluate the incidence of type 2 diabetes secondary to AP of patients admitted for AP with portosplenomesenteric vein
hospital mortality at D90	Day 90	evaluate the hospitality mortality at D90 of patients admitted for AP with portosplenomesenteric vein
hospital mortality at D28	Day 28	evaluate the hospitality mortality at D28 of patients admitted for AP with portosplenomesenteric vein

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France