Evaluation of Portal Vein Stenting in Patients With Portal Vein Stenosis and Gastrointestinal Cancers
Prospective Evaluation of Portal Vein (PV) Stenting in Patients With PV Stenosis and Gastrointestinal Malignancies
2 other identifiers
observational
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2019
CompletedFirst Submitted
Initial submission to the registry
November 9, 2020
CompletedFirst Posted
Study publicly available on registry
November 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedJanuary 12, 2026
January 1, 2026
7.1 years
November 9, 2020
January 8, 2026
Conditions
Outcome Measures
Primary Outcomes (15)
Patency rate (Cohort A)
Defined by successful stent placement and described as N (%) of patients with corresponding exact 95% confidence interval.
Up to 8 weeks after stent placement
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.
Up to 8 weeks after stent placement
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.
Up to 8 weeks after stent placement
Duration of clinical success (Cohort A)
Mean, median, standard deviation, and minimum/maximum values will be described.
Up to 8 weeks after stent placement
Change in nutritional status (Cohort A)
Based on albumin, pre-albumin, weight, body fat, and body surface area (BSA). Methods such as repeated measures analysis of variance (ANOVA) with post-hoc Tukey test and generalized estimating equations (GEE) will be used to assess pre- and post- differences.
Baseline up to 30 days post procedure
Change in bleeding risk (Cohort A)
Based on platelet count and coagulation factors. Methods such as repeated measures ANOVA with post-hoc Tukey test and GEE will be used to assess pre- and post- differences.
Baseline up to 30 days post procedure
Change in liver function (Cohort A)
Methods such as repeated measures ANOVA with post-hoc Tukey test and GEE will be used to assess pre- and post- differences.
Baseline up to 30 days post procedure
Change in liver volume (Cohort A)
Methods such as repeated measures ANOVA with post-hoc Tukey test and GEE will be used to assess pre- and post- differences.
Baseline up to 30 days post procedure
Change in quality of life (QoL) (Cohort A)
Will be assessed based on National Comprehensive Cancer Network - Hepatibiliary Symptom Index Questionnaire - 18 item. Methods such as repeated measures ANOVA with post-hoc Tukey test and GEE will be used to assess pre- and post- differences. For QoL will also present effect size, defined as the magnitude of the differences in relation to the standard deviation of the scores, which will be reflective of the strength of the effect of portal stenting on QoL.
Baseline up to 30 days post procedure
Number of transfusions (Cohort A and B)
Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.
Up to 8 weeks post procedure
Number of paracentesis for ascites (Cohort A and B)
Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.
Up to 8 weeks post procedure
Liver volume (Cohort A and B)
Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.
Up to 8 weeks post procedure
Liver function (Cohort A and B)
Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.
Up to 8 weeks post procedure
Nutritional status (Cohort A and B)
Based on albumin, pre-albumin, weight, body fat, and BSA. Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.
Up to 8 weeks post procedure
Bleeding risk (Cohort A and B)
Based on platelet count and coagulation factors. Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.
Up to 8 weeks post procedure
Study Arms (2)
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.
Cohort B (medical record review)
Patients' medical records are reviewed retrospectively.
Interventions
Review of medical records
Ancillary studies
Complete questionnaires
Eligibility Criteria
Gastrointestinal cancer patients with portal vein stenosis
You may qualify if:
- COHORT A: All patients will undergo initial staging and treatment as per the institution standard of care. Patients will be considered eligible for porto-mesenteric venous stenting (PVS) if:
- 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
- COHORT B: Patients who have thrombosis/stenosis of the main portal vein but who did not undergo stenting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua D Kuban
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2020
First Posted
November 16, 2020
Study Start
April 2, 2019
Primary Completion
April 30, 2026
Study Completion
April 30, 2026
Last Updated
January 12, 2026
Record last verified: 2026-01