Acute Pancreatitis and Thrombosis (PATHRO)

NCT04642794 | Completed

• 1 other identifier: MR_PATHRO
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• evaluate the outcomes of Number of patients admitted for AP with portosplenomesenteric vein thrombosis

  up to 12 months

• hospital mortality at D28

  Day 28

• hospital mortality at D90

  Day 90

• hospital mortality at 6 months

  6 months

• hospital mortality at 12 months

  12 months

Interventions

observational study OTHER

patients admitted for AP with portosplenomesenteric vein thrombosis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients admitted for AP with portosplenomesenteric vein thrombosis

You may qualify if:

• 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.

You may not qualify if:

• Patient under guardianship
• Refusal to participate in research
• Pregnancy

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, France

Location

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing; Pancreatitis; Pancreatic Diseases; Hemorrhage

Interventions

Observation

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• GARRET Charlotte, MD

  University hospital of Nantes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 24, 2020
• Study Start: November 1, 2020
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

FR (1)