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Acute Necrotizing PancreatitisPATHRONCT04642794

Acute Pancreatitis and Thrombosis (PATHRO)

An observational study of Acute Necrotizing Pancreatitis and Portosplenomesenteric Venous Thrombosis, run by Nantes University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
observational study
How many people
51 participants
Where
1 siteFrance
Study dates
1 Nov 2020to 15 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients admitted for AP with portosplenomesenteric vein thrombosis

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Nantes

    Nantes

Other trials in France

About this study

Official title: 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.

Read the detailed description

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

Being tested
observational study
Keywords
acute necrotizing pancreatitis, acute pancreatitis, pancreas disease, anticoagulation, anticolagulant therapy, bleeding, Portosplenomesenteric Vein Thrombosis, splanchic venous thrombosis
Medical subject headings
Pancreatitis, Acute Necrotizing, Pancreatitis, Pancreatic Diseases, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • observational studyOther

    patients admitted for AP with portosplenomesenteric vein thrombosis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 12 months

Secondary outcomes (11)

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

    Measured: up to 12 months

  2. hospital mortality at D28

    evaluate the hospitality mortality at D28 of patients admitted for AP with portosplenomesenteric vein

    Measured: Day 28

  3. hospital mortality at D90

    evaluate the hospitality mortality at D90 of patients admitted for AP with portosplenomesenteric vein

    Measured: Day 90

  4. hospital mortality at 6 months

    evaluate the hospitality mortality at 6 months of patients admitted for AP with portosplenomesenteric vein

    Measured: 6 months

  5. hospital mortality at 12 months

    evaluate the hospitality mortality at 12 months of patients admitted for AP with portosplenomesenteric vein

    Measured: 12 months

  6. incidence of portal cavernoma

    evaluate the incidence of portal cavernoma of patients admitted for AP with portosplenomesenteric vein

    Measured: up to 12 months

  7. 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

    Measured: up to 12 months

  8. incidence of occurrence of malabsorption

    evaluate the incidence of occurrence of malabsorption of patients admitted for AP with portosplenomesenteric vein

    Measured: up to 12 months

  9. incidence of digestive ischemia

    evaluate the incidence of digestive ischemia of patients admitted for AP with portosplenomesenteric vein

    Measured: up to 12 months

  10. incidence of hepatic ischemia

    evaluate the incidence of hepatic ischemia of patients admitted for AP with portosplenomesenteric vein

    Measured: up to 12 months

  11. incidence of pancreatic necrosis

    evaluate the incidence of pancreatic necrosis of patients admitted for AP with portosplenomesenteric vein

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2020
  2. Study start1 Nov 2020
  3. Primary completion15 Jul 2022
  4. Study completion15 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04642794
Sponsor's protocol ID
MR_PATHRO
Acronym
PATHRO
Status last verified
Jul 2024
First submitted
17 Nov 2020
Last updated
11 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Necrotizing Pancreatitis and Portosplenomesenteric Venous Thrombosis, run by Nantes University Hospital at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of anticoagulation therapy (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04642794.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024; AzTrials last refreshed its copy on 27 Oct 2026.

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