Prospective Evaluation of Portal Vein (PV) Stenting in Patients With PV Stenosis and Gastrointestinal Malignancies
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.
Detailed description
PRIMARY OBJECTIVE: 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.
Arms & interventions
- OtherElectronic Health Record Review
Review of medical records
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Complete questionnaires
Outcome measures
Primary
Patency rate (Cohort A)
Defined by successful stent placement and described as N (%) of patients with corresponding exact 95% confidence interval.
Time frame: 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.
Time frame: 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.
Time frame: Up to 8 weeks after stent placement
Duration of clinical success (Cohort A)
Mean, median, standard deviation, and minimum/maximum values will be described.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 8 weeks post procedure
Eligibility criteria
Study locations (1)
M D Anderson Cancer Center
Houston, Texas, 77030