Clinical trial NCT04814251: Portal Vein Thrombosis Associated With Unresectable Pancreatic Cancers : a Prospective Multicentric Cohort Study
Official title: A Prospective and Multicentric Cohort Study Evaluating the Complications of Portal Vein Thrombosis in Patients With Locally Advanced Pancreatic Cancer : THROMPAN
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Adenocarcinoma
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed for unresectable pancreatic adenocarcinoma with portal vein thrombosis or portal hypertension with scan evidence (splenomegaly and/or portosystemic shunts).

Brief 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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Rate of digestive and non-digestive bleeding
timeFrame: 18 months
Secondary outcomes:
measure: Screening rate of oesophageal varices by upper gastriintestinal endoscopy,
timeFrame: 18 months
measure: Detection rate of oesophageal varices
timeFrame: 18 months
measure: Rate of primary prophylaxis of oesophageal varices
timeFrame: 18 months
measure: Rate of secondary prophylaxis of oesophageal varices
timeFrame: 18 months
measure: Rate of anticoagulant treatment use
timeFrame: 18 months
measure: Portal hypertension related death, predictive factors of gastrointestinal bleeding and overall survival.
timeFrame: 18 months
Other outcomes:
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