Evaluation of Portal Vein Stenting in Patients With Portal Vein Stenosis and Gastrointestinal Cancers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Evaluation of Portal Vein (PV) Stenting in Patients With PV Stenosis and Gastrointestinal Malignancies

Conditions
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Malignant Digestive System Neoplasm

Intervention / Treatment
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* Other: Electronic Health Record Review
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A (questionnaire, medical record review)<br>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. | Other: Electronic Health Record Review<br>* Review of medical records<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete questionnaires<br>|
| Cohort B (medical record review)<br>Patients' medical records are reviewed retrospectively. | Other: Electronic Health Record Review<br>* Review of medical records<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |