Clinical trial NCT04629677: Evaluation of Portal Vein Stenting in Patients With Portal Vein Stenosis and Gastrointestinal Cancers
Official title: Prospective Evaluation of Portal Vein (PV) Stenting in Patients With PV Stenosis and Gastrointestinal Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Digestive System Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-11-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gastrointestinal cancer patients with portal vein stenosis

Brief 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.

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

Primary outcomes:
measure: Patency rate (Cohort A)
timeFrame: Up to 8 weeks after stent placement
measure: Transfusion rate (Cohort A)
timeFrame: Up to 8 weeks after stent placement
measure: Rate of paracenteses for ascites (Cohort A)
timeFrame: Up to 8 weeks after stent placement
measure: Duration of clinical success (Cohort A)
timeFrame: Up to 8 weeks after stent placement
measure: Change in nutritional status (Cohort A)
timeFrame: Baseline up to 30 days post procedure
measure: Change in bleeding risk (Cohort A)
timeFrame: Baseline up to 30 days post procedure
measure: Change in liver function (Cohort A)
timeFrame: Baseline up to 30 days post procedure
measure: Change in liver volume (Cohort A)
timeFrame: Baseline up to 30 days post procedure
measure: Change in quality of life (QoL) (Cohort A)
timeFrame: Baseline up to 30 days post procedure
measure: Number of transfusions (Cohort A and B)
timeFrame: Up to 8 weeks post procedure
measure: Number of paracentesis for ascites (Cohort A and B)
timeFrame: Up to 8 weeks post procedure
measure: Liver volume (Cohort A and B)
timeFrame: Up to 8 weeks post procedure
measure: Liver function (Cohort A and B)
timeFrame: Up to 8 weeks post procedure
measure: Nutritional status (Cohort A and B)
timeFrame: Up to 8 weeks post procedure
measure: Bleeding risk (Cohort A and B)
timeFrame: Up to 8 weeks post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Joshua D Kuban
role: PRINCIPAL_INVESTIGATOR
References: