Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT04814251
Status:
UNKNOWN
Last Update Posted:
2021-03-24
First Post:
2021-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Portal Vein Thrombosis Associated With Unresectable Pancreatic Cancers : a Prospective Multicentric Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '18 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of digestive and non-digestive bleeding', 'timeFrame': '18 months', 'description': 'Hematemesis, melena and / or rectal bleeding Hematuria, intra-abdominal, intracranial bleeding and / or other bleeding considered clinically relevant by the investigators'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Adenocarcinoma']}, 'descriptionModule': {'briefSummary': '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%).\n\nWe 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).\n\nBleeding 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients followed for unresectable pancreatic adenocarcinoma with portal vein thrombosis or portal hypertension with scan evidence (splenomegaly and/or portosystemic shunts).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pancreatic adenocarcinoma proven histologically or cytologically in favor of pancreatic adenocarcinoma\n* Mesurable disease according to RECIST 1.1 criteria or non measurable disease\n* 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\n* 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\n\nExclusion Criteria:\n\n* \\- Post-surgical portal vein thrombosis and / or in patients considered in remission\n* Non-adenocarcinomatous pancreatic tumor (endocrine, etc.)'}, 'identificationModule': {'nctId': 'NCT04814251', 'acronym': 'THROMPAN', 'briefTitle': 'Portal Vein Thrombosis Associated With Unresectable Pancreatic Cancers : a Prospective Multicentric Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'A Prospective and Multicentric Cohort Study Evaluating the Complications of Portal Vein Thrombosis in Patients With Locally Advanced Pancreatic Cancer : THROMPAN', 'orgStudyIdInfo': {'id': 'THROMPAN'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observationnal cohort', 'type': 'OTHER', 'description': 'data collection'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sheik EMAMBUX', 'role': 'CONTACT', 'email': 'sheik.emambux@chu-poitiers.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}