NCT04814251

Portal Vein Thrombosis Associated With Unresectable Pancreatic Cancers : a Prospective Multicentric Cohort Study

A Prospective and Multicentric Cohort Study Evaluating the Complications of Portal Vein Thrombosis in Patients With Locally Advanced Pancreatic Cancer : THROMPAN

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: —

Summary

Little is known concerning the management of portal vein thrombosis (PVT) in digestive cancers other than hepato-cellular carcinoma (HCC). The use of anticoagulant treatment (ACT), screening of oesophageal varices (OV) and oesogatric varices (OGV), and primary prophylaxis of OV (treatment with beta-blocker (BB) and / or OV ligation) if necessary are not clearly defined. The autopsy series by Ogren et al. (World J Gastroenterol. 2006) found an incidence of PVT in cancer patients of 1%, with 44% of digestive cancers other than HCC as a common etiology, mostly pancreatic adenocarcinoma (42%). We reported a retrospective French study that included 118 patients with digestive cancers other than HCC, including 50% locally advanced or metastatic pancreatic adenocarcinoma, with PVT complications. A total of 38% of patients had radiological signs of portal hypertension (PHT) and 51% had ACT. Only 1% of patients were screened for VO (n = 7). In addition, 19% (n = 22) presented gastrointestinal bleeding. Among the causes of death, 17% (n = 12) were due to gastrointestinal bleeding. Overall survival (OS) was statistically associated with a metastatic disease (HR = 2.83 \[95% CI 1.47-5.43\], p \<0.01) and gastrointestinal bleeding (HR = 1.68 \[95% CI 1.01-2.78\], p = 0.04). Bleeding complications from PHT are not uncommon in patients with digestive cancer, especially in patients with pancreatic cancer with PVT; but above all they can be responsible for death. No data existed before our first study (Regnault et al. Dig Liv Dis 2018). However, these data must be validated in a prospective multicentric study with standardized follow-up. In order to obtain precise and homogeneous data, we have chosen to target pancreatic cancers as these tumors are the most common causes of PVT.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
OTHER	Observationnal cohort	data collection

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-03-01
• Completion: 2024-12-01
• First posted: 2021-03-24
• Last updated: 2021-03-24