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

Last updated: July 28, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Ulcers

Digestive System Neoplasms

Stomach Cancer

Treatment

Questionnaire Administration

Electronic Health Record Review

Quality-of-Life Assessment

Clinical Study ID

NCT04629677
PA18-0712
PA18-0712
NCI-2020-07171
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: Questionnaire Administration
Phase:
Study Start date:
April 02, 2019
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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