Actively Recruiting
Prospective Evaluation of Portal Vein Stenting in Patients With Portal Vein Stenosis and Gastrointestinal Malignancies
Led by M.D. Anderson Cancer Center · Updated on 2026-01-12
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of portal vein stenting in patients with gastrointestinal cancers who have narrowing of the portal vein. The study aims to learn how long the portal vein remains open and free from blockage after stenting, and how this procedure affects patients' overall well-being and quality of life. It compares patients who receive the stenting procedure with those who do not undergo stenting. Patients are divided into two groups. Cohort A includes patients who receive portal vein stenting and complete quality of life questionnaires at 2-4 weeks and again at 6-8 weeks after the procedure, with their medical records reviewed. Cohort B includes patients with portal vein narrowing or thrombosis who did not receive stenting, and only their medical records are reviewed retrospectively. Participants in Cohort A will have their quality of life, liver function, liver volume, nutritional status, bleeding risk, transfusion needs, and ascites management monitored up to 8 weeks after stenting. Both cohorts will have medical records reviewed for these outcomes. This study is observational, focusing on collecting data and assessing outcomes related to the portal vein stenting procedure and its effects on patients with gastrointestinal cancer and portal vein stenosis.
CONDITIONS
Brief Title
Evaluation of Portal Vein Stenting in Patients With Portal Vein Stenosis and Gastrointestinal Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years or older.
- Patients with gastrointestinal cancer undergoing standard staging and treatment.
- Patients with more than 75% narrowing in the main portal vein, left portal vein, right portal vein, or superior mesenteric vein, regardless of symptoms.
- Patients with any degree of vascular narrowing and symptoms of portal hypertension such as variceal bleeding, refractory ascites, abdominal pain, intestinal swelling, or diarrhea after ruling out tumor invasion or spread.
- For Cohort B, patients with thrombosis or narrowing of the main portal vein who did not have stenting.
You will not qualify if you...
- Patients with vascular narrowing caused directly by tumor invasion or peritoneal spread.
- Patients who do not meet the age requirement of being 18 years or older.
- Patients without portal vein stenosis or thrombosis.
- Patients who have undergone portal vein stenting prior to the study (for Cohort B).
- Patients unable to complete quality of life questionnaires or medical record review as required for Cohort A or B respectively, if applicable.
- Patients with other medical conditions that may interfere with study participation or outcomes, as determined by the investigator (implied).
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and consent
Duration - Up to 8 weeks after stent placement
Participants in Cohort A undergo portal vein stenting and complete quality of life questionnaires at 2 to 4 weeks and 6 to 8 weeks after the procedure. Medical records are reviewed for both cohorts.
2 visits for questionnaire completion in Cohort A; medical record reviews for all participants
Duration - Up to 8 weeks post procedure
Participants' medical records are reviewed retrospectively to evaluate clinical outcomes such as transfusion rates, liver function, and nutritional status.
No additional visits; medical record review only
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Joshua D. Kuban
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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