Malignant Digestive System Neoplasm
Conditions
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.
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.
Interventions
OTHERElectronic Health Record Review
Review of medical records
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Complete questionnaires
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patency rate (Cohort A) | Up to 8 weeks after stent placement | Defined by successful stent placement and described as N (%) of patients with corresponding exact 95% confidence interval. |
| Transfusion rate (Cohort A) | Up to 8 weeks after stent placement | 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) | Up to 8 weeks after stent placement | 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) | Up to 8 weeks after stent placement | Mean, median, standard deviation, and minimum/maximum values will be described. |
| Change in nutritional status (Cohort A) | Baseline up to 30 days post procedure | 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. |
| Change in bleeding risk (Cohort A) | Baseline up to 30 days post procedure | 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. |
| Change in liver function (Cohort A) | Baseline up to 30 days post procedure | Methods such as repeated measures ANOVA with post-hoc Tukey test and GEE will be used to assess pre- and post- differences. |
| Change in liver volume (Cohort A) | Baseline up to 30 days post procedure | Methods such as repeated measures ANOVA with post-hoc Tukey test and GEE will be used to assess pre- and post- differences. |
| Change in quality of life (QoL) (Cohort A) | Baseline up to 30 days post procedure | 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. |
| Number of transfusions (Cohort A and B) | Up to 8 weeks post procedure | Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort. |
| Number of paracentesis for ascites (Cohort A and B) | Up to 8 weeks post procedure | Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort. |
| Liver volume (Cohort A and B) | Up to 8 weeks post procedure | Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort. |
| Liver function (Cohort A and B) | Up to 8 weeks post procedure | Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort. |
| Nutritional status (Cohort A and B) | Up to 8 weeks post procedure | 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. |
| Bleeding risk (Cohort A and B) | Up to 8 weeks post procedure | 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. |
Countries
United States
Contacts
CONTACTJoshua D. Kuban
PRINCIPAL_INVESTIGATORJoshua D Kuban
M.D. Anderson Cancer Center
Outcome results
None listed