Trials / Recruiting
RecruitingNCT04629677
Evaluation of Portal Vein Stenting in Patients With Portal Vein Stenosis and Gastrointestinal Cancers
Prospective Evaluation of Portal Vein (PV) Stenting in Patients With PV Stenosis and Gastrointestinal Malignancies
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Electronic Health Record Review | Review of medical records |
| OTHER | Quality-of-Life Assessment | Ancillary studies |
| OTHER | Questionnaire Administration | Complete questionnaires |
Timeline
- Start date
- 2019-04-02
- Primary completion
- 2026-04-30
- Completion
- 2026-04-30
- First posted
- 2020-11-16
- Last updated
- 2026-01-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04629677. Inclusion in this directory is not an endorsement.