Prospective Evaluation of Portal Vein (PV) Stenting in Patients With PV Stenosis and Gastrointestinal Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in liver volume (Cohort A)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Electronic Health Record Review (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Questionnaire Administration (Other)
Cohort B (medical record review)
Patients' medical records are reviewed retrospectively.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Change in liver volume (Cohort A)
时间窗: 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.
Transfusion rate (Cohort A)
时间窗: 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.
Duration of clinical success (Cohort A)
时间窗: Up to 8 weeks after stent placement
Mean, median, standard deviation, and minimum/maximum values will be described.
Change in bleeding risk (Cohort A)
时间窗: 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)
时间窗: 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)
时间窗: 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.
Patency rate (Cohort A)
时间窗: Up to 8 weeks after stent placement
Defined by successful stent placement and described as N (%) of patients with corresponding exact 95% confidence interval.
Nutritional status (Cohort A and B)
时间窗: 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)
时间窗: 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.
Rate of paracenteses for ascites (Cohort A)
时间窗: 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.
Change in nutritional status (Cohort A)
时间窗: 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.
Number of transfusions (Cohort A and B)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点