Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04814251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-03-24
First Post:
2021-03-22
Brief Title:
Portal Vein Thrombosis Associated With Unresectable Pancreatic Cancers a Prospective Multicentric Cohort Study
Sponsor:
Poitiers University Hospital
Organization:
Poitiers University Hospital
Study Overview
Official Title:
A Prospective and Multicentric Cohort Study Evaluating the Complications of Portal Vein Thrombosis in Patients With Locally Advanced Pancreatic Cancer THROMPAN
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THROMPAN
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 283 95 CI 147-543 p 001 and gastrointestinal bleeding HR 168 95 CI 101-278 p 004
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
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 283 95 CI 147-543 p 001 and gastrointestinal bleeding HR 168 95 CI 101-278 p 004
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None