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

Pancreatic Adenocarcinoma Clinical Trial

— THROMPAN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04814251
• Other study ID #: THROMPAN
• Status: Not yet recruiting
• Start date: March 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2021
• Source: Poitiers University Hospital
• Contact: Sheik EMAMBUX
• Email: sheik.emambux[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: March 2023
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Pancreatic Adenocarcinoma
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• Observationnal cohort
data collection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Screening rate of oesophageal varices by upper gastriintestinal endoscopy,		18 months
Secondary	Detection rate of oesophageal varices		18 months
Secondary	Rate of primary prophylaxis of oesophageal varices		18 months
Secondary	Rate of secondary prophylaxis of oesophageal varices		18 months
Secondary	Rate of anticoagulant treatment use		18 months
Secondary	Portal hypertension related death, predictive factors of gastrointestinal bleeding and overall survival.		18 months