Risk Factors for Recurrence of Thrombosis or Thrombotic Extension, in the Event of Acute Non-cirrhotic Portal Vein Thrombosis Secondary to a Local Cause.

Completed

• Conditions: Portal Vein Thrombosis; Local Cause

• Registration Number: NCT05360641
• Lead Sponsor: University Hospital, Caen

Brief Summary

In case of acute portal vein thrombosis (PVT) prothrombotic factors are identified in about 60% of cases, while a local condition is present in 30% of cases. Prothrombotic factors may indicate a long term anticoagulant therapy whereas the risk of recurrence seems low when a local condition is isolated (cholecystitis, angiocholitis, liver abces, diverticulitis, appendicitis, acute/chronic pancreatitis, chronic bowel inflammatory disease, acute hepatitis due to cytomegalovirus, bacteroïdes pylephlebitis, abdominal neoplasia such as adenocarcinoma of the colon, abdominal traumatism or surgery such as cholecystectomy, bariatric surgery or splenectomy). To date the impact of prothrombotic factors associated with local conditions responsible for acute PVT has not been well studied except for acute or chronic pancreatitis. No significant association has been pointed out in this pathology. The aim is to determine what are the risk factors of thrombotic recurrence or extension associated with local conditions responsible for acute non cirrhotic PVT, and to evaluate the rate of secondary long term anticoagulant therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-29
• Study First Posted: 2022-05-04
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• acute portal thrombosis segmental or truncal, diagnosed in the context of a local inflammatory, infectious, trauma or abdominal surgery cause, dating from less than 3 months.
• patients already included in european cohort ENVIE-VALDIG

Exclusion Criteria

• liver cirrhosis
• liver, biliary or pancreatic neoplasia
• thrombosis limited to mesenteric vein, splenic vein or splenomesaraic confluence
• cavernoma or Budd-Chiari syndrom

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of thrombosis at 5 years	5 years	Risk factor for recurrence of thrombosis at 5 years (regardless of territory), or splanchnic thrombotic extension, in case of acute non-cirrhotic PVT secondary to a local cause of infection, inflammation, trauma or abdominal surgery.

Secondary Outcome Measures

Name	Time	Method
Prevalence of thrombotic factors	5 years	Prevalence of thrombotic factors with its 95% confidence interval.
Prothrombotic factors	5 years	Interest of a systematic search for prothrombotic factors in terms of prevention of recurrence of thrombosis, mortality (morbidity, mortality)
Long-term anticoagulation	5 years	Percentage of indications for long-term anticoagulation at the end of the exhaustive search for prothrombotic factors: this percentage will be estimated with its IC 95

Trial Locations

Locations (1)

Chu de Caen; 🇫🇷 Caen, Calvados, France