Evaluation of Portal Vein Stenting in Patients With Portal Vein Stenosis and Gastrointestinal Cancers
NCT ID: NCT04629677
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2019-04-02
2026-04-30
Brief Summary
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Detailed Description
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I. To evaluate the safety and efficacy of portal vein stenting in patients with portal vein (PV) stenosis and gastrointestinal malignancies, including quality of life measurements.
SECONDARY OBJECTIVES:
I. Stent patency and duration of clinical success related to the intervention. II. Compare the efficacy of portal vein stenting on liver volumes, nutritional status, and laboratory values relative to patients with portal vein stenosis/thrombosis who do not undergo portal vein stenting.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT A: Patients complete a quality of life (QoL) questionnaire at 2-4 weeks and then 6-8 weeks after portal vein stenting procedure. Patients' medical records are also reviewed.
COHORT B: Patients' medical records are reviewed retrospectively.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Cohort A (questionnaire, medical record review)
Patients complete a QoL questionnaire at 2-4 weeks and then 6-8 weeks after portal vein stenting procedure. Patients' medical records are also reviewed.
Electronic Health Record Review
Review of medical records
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete questionnaires
Cohort B (medical record review)
Patients' medical records are reviewed retrospectively.
Electronic Health Record Review
Review of medical records
Interventions
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Electronic Health Record Review
Review of medical records
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete questionnaires
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* There is \> 75% porto-mesenteric venous stenosis in either main portal vein (PV), left PV, right PV, or the superior mesenteric vein (SMV), even in absence of symptoms of portal hypertension
* Patients presented with any degree of vascular narrowing of said vessels and symptomatic portal hypertension including variceal bleeding, refractory ascites, abdominal pain, intestinal edema, or diarrhea after exclusion of tumor-related causes as direct tumor invasion or peritoneal dissemination
* COHORT B: Patients who have thrombosis/stenosis of the main portal vein but who did not undergo stenting
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Joshua D Kuban
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Joshua D. Kuban
Role: primary
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2020-07171
Identifier Type: REGISTRY
Identifier Source: secondary_id
PA18-0712
Identifier Type: OTHER
Identifier Source: secondary_id
PA18-0712
Identifier Type: -
Identifier Source: org_study_id
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