NCT04629677Recruiting

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

M.D. Anderson Cancer Center

Start Date

4/2/2019

Completion Date

4/30/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

OTHER

Electronic Health Record Review

OTHER

Quality-of-Life Assessment

OTHER

Questionnaire Administration

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Conditions

Malignant Digestive System Neoplasm

Locations

M D Anderson Cancer Center

Houston, Texas 77030

United States