About this trial
This study collects information about the safety and effect of portal vein stenting in gastrointestinal cancer patients with portal vein stenosis. This study may help researchers learn how long the portal vein stays open and free from blockage and the effects of portal vein stenting on patients' overall well-being.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Gastrointestinal cancer patients with portal vein stenosis
Trial design
Cohort
Other
Treatments tested in this trial
Electronic Health Record Review
Other interventionReview of medical records
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionComplete questionnaires
Treatment groups
Trial outcomes
Primary outcomes
Patency rate (Cohort A)
Defined by successful stent placement and described as N (%) of patients with corresponding exact 95% confidence interval.
Transfusion rate (Cohort A)
N (%) of patients receiving transfusion with corresponding exact 95% confidence interval. Instances of multiple transfusions per patient will also be described.
Rate of paracenteses for ascites (Cohort A)
N (%) of patients receiving paracenteses with corresponding exact 95% confidence interval. Instances of multiple paracenteses per patient will also be described.
Duration of clinical success (Cohort A)
Mean, median, standard deviation, and minimum/maximum values will be described.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator