Evaluating portal vein stenting for patients with gastrointestinal cancers and vein narrowing
Prospective Evaluation of Portal Vein (PV) Stenting in Patients With PV Stenosis and Gastrointestinal Malignancies
This study is testing if putting a stent in the portal vein can help people with gastrointestinal cancers and vein narrowing feel better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04629677 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and effectiveness of portal vein stenting in patients suffering from portal vein stenosis associated with gastrointestinal cancers. It involves two cohorts: one that receives stenting and completes quality of life assessments, and another that is reviewed retrospectively without stenting. The study will measure stent patency, clinical success duration, and impacts on liver volumes and nutritional status. The goal is to gather data that could enhance patient care and outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates include patients with significant portal vein stenosis and gastrointestinal malignancies who are undergoing standard treatment.
Not a fit: Patients with portal vein stenosis who do not have gastrointestinal cancers or those who are not eligible for stenting may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life and clinical outcomes for patients with gastrointestinal cancers and portal vein stenosis.
How similar studies have performed: While the approach of portal vein stenting has been explored, this specific evaluation in the context of gastrointestinal cancers is relatively novel.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Joshua D Kuban — M.D. Anderson Cancer Center
- Study coordinator: Joshua D. Kuban
- Email: jdkuban@mdanderson.org
- Phone: 713-745-0944
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.