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Recruiting NCT04629677

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

— Observational Malignant Digestive System Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electronic Health Record Review, Quality-of-Life Assessment, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Malignant Digestive System Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Evaluation of Portal Vein (PV) Stenting in Patients With PV Stenosis and Gastrointestinal Malignancies

Overview

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.

Interventions

  • Other Electronic Health Record Review
    Review of medical records
  • Other Quality-of-Life Assessment
    Ancillary studies
  • Other Questionnaire Administration
    Complete questionnaires

Primary outcome measures

  • Patency rate (Cohort A) [Time frame: Up to 8 weeks after stent placement]
  • Transfusion rate (Cohort A) [Time frame: Up to 8 weeks after stent placement]
  • Rate of paracenteses for ascites (Cohort A) [Time frame: Up to 8 weeks after stent placement]
  • Duration of clinical success (Cohort A) [Time frame: Up to 8 weeks after stent placement]
  • Change in nutritional status (Cohort A) [Time frame: Baseline up to 30 days post procedure]
  • Change in bleeding risk (Cohort A) [Time frame: Baseline up to 30 days post procedure]
  • Change in liver function (Cohort A) [Time frame: Baseline up to 30 days post procedure]
  • Change in liver volume (Cohort A) [Time frame: Baseline up to 30 days post procedure]
  • Change in quality of life (QoL) (Cohort A) [Time frame: Baseline up to 30 days post procedure]
  • Number of transfusions (Cohort A and B) [Time frame: Up to 8 weeks post procedure]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT04629677 · PA18-0712 · NCI-2020-07171 · PA18-0712

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗