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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Malignant Digestive System Neoplasm

Treatments: Other: Electronic Health Record Review; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04629677

PA18-0712 (Other Identifier)

NCI-2020-07171 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

150 participants in 2 patient groups

Cohort A (questionnaire, medical record review)

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Electronic Health Record Review

Cohort B (medical record review)

Description:

Patients' medical records are reviewed retrospectively.

Treatment:

Other: Electronic Health Record Review