Portal Vein Thrombosis Associated With Unresectable Pancreatic Cancers : a Prospective Multicentric Cohort Study
- Conditions
- Pancreatic Adenocarcinoma
- Registration Number
- NCT04814251
- Lead Sponsor
- Poitiers University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
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- Post-surgical portal vein thrombosis and / or in patients considered in remission
- Non-adenocarcinomatous pancreatic tumor (endocrine, etc.)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of digestive and non-digestive bleeding 18 months Hematemesis, melena and / or rectal bleeding Hematuria, intra-abdominal, intracranial bleeding and / or other bleeding considered clinically relevant by the investigators
- Secondary Outcome Measures
Name Time Method Rate of anticoagulant treatment use 18 months Screening rate of oesophageal varices by upper gastriintestinal endoscopy, 18 months Portal hypertension related death, predictive factors of gastrointestinal bleeding and overall survival. 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