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

Study Overview

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

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.

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Pancreatic Adenocarcinoma

OTHER: Observationnal cohort

THROMPAN

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-03-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-03-22
First Submitted that Met QC Criteria 2021-03-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-03-24
First Posted (ACTUAL) 2021-03-24	Results First Posted N/A	Last Verified 2021-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
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Allocation:
N/A

Interventional Model:
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Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sheik EMAMBUX

Phone Number:

Email: sheik.emambux@chu-poitiers.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

- Post-surgical portal vein thrombosis and / or in patients considered in remission
Non-adenocarcinomatous pancreatic tumor (endocrine, etc.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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Clinical Trial Record