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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatic Adenocarcinoma

Intervention / Treatment
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* Other: Observationnal cohort


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pancreatic adenocarcinoma proven histologically or cytologically in favor of pancreatic adenocarcinoma Mesurable disease according to RECIST 1.1 criteria or non measurable disease Metastatic disease (synchronous or metachronous) or locally advanced / borderline deemed unresectable and / or patient inoperable due to his co-morbidities and / or local recurrence after surgery Thrombosis of the main portal vein and/or of one of its branches (endo-luminal defect on the injected CTscan) of cruoric or tumoral origin or circumferential stenosis of the portal vein trunk, the spleno-mesaraic confluence or one of its venous branches with or without signs of portal hypertension on CTscan and / or upper GIendoscopy Exclusion Criteria: - Post-surgical portal vein thrombosis and / or in patients considered in remission Non-adenocarcinomatous pancreatic tumor (endocrine, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observationnal cohort|data collection|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of digestive and non-digestive bleeding | Hematemesis, melena and / or rectal bleeding Hematuria, intra-abdominal, intracranial bleeding and / or other bleeding considered clinically relevant by the investigators | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening rate of oesophageal varices by upper gastriintestinal endoscopy, |  | 18 months | 
| Detection rate of oesophageal varices |  | 18 months | 
| Rate of primary prophylaxis of oesophageal varices |  | 18 months | 
| Rate of secondary prophylaxis of oesophageal varices |  | 18 months | 
| Rate of anticoagulant treatment use |  | 18 months | 
| Portal hypertension related death, predictive factors of gastrointestinal bleeding and overall survival. |  | 18 months |