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NCT Number: NCT04629677

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

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.

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Key information

Conditions

Malignant Digestive System Neoplasm Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Joshua D. Kuban

CONTACT

713-745-0944

Joshua D. Kuban

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Health Record Review

Other

Review of medical records

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  1. Patency rate (Cohort A)

    Time frame: Up to 8 weeks after stent placement

    Defined by successful stent placement and described as N (%) of patients with corresponding exact 95% confidence interval.

  2. Transfusion rate (Cohort A)

    Time frame: Up to 8 weeks after stent placement

    N (%) of patients receiving transfusion with corresponding exact 95% confidence interval. Instances of multiple transfusions per patient will also be described.

  3. Rate of paracenteses for ascites (Cohort A)

    Time frame: Up to 8 weeks after stent placement

    N (%) of patients receiving paracenteses with corresponding exact 95% confidence interval. Instances of multiple paracenteses per patient will also be described.

  4. Duration of clinical success (Cohort A)

    Time frame: Up to 8 weeks after stent placement

    Mean, median, standard deviation, and minimum/maximum values will be described.

  5. Change in nutritional status (Cohort A)

    Time frame: Baseline up to 30 days post procedure

    Based on albumin, pre-albumin, weight, body fat, and body surface area (BSA). Methods such as repeated measures analysis of variance (ANOVA) with post-hoc Tukey test and generalized estimating equations (GEE) will be used to assess pre- and post- differences.

  6. Change in bleeding risk (Cohort A)

    Time frame: Baseline up to 30 days post procedure

    Based on platelet count and coagulation factors. Methods such as repeated measures ANOVA with post-hoc Tukey test and GEE will be used to assess pre- and post- differences.

  7. Change in liver function (Cohort A)

    Time frame: Baseline up to 30 days post procedure

    Methods such as repeated measures ANOVA with post-hoc Tukey test and GEE will be used to assess pre- and post- differences.

  8. Change in liver volume (Cohort A)

    Time frame: Baseline up to 30 days post procedure

    Methods such as repeated measures ANOVA with post-hoc Tukey test and GEE will be used to assess pre- and post- differences.

  9. Change in quality of life (QoL) (Cohort A)

    Time frame: Baseline up to 30 days post procedure

    Will be assessed based on National Comprehensive Cancer Network - Hepatibiliary Symptom Index Questionnaire - 18 item. Methods such as repeated measures ANOVA with post-hoc Tukey test and GEE will be used to assess pre- and post- differences. For QoL will also present effect size, defined as the magnitude of the differences in relation to the standard deviation of the scores, which will be reflective of the strength of the effect of portal stenting on QoL.

  10. Number of transfusions (Cohort A and B)

    Time frame: Up to 8 weeks post procedure

    Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.

  11. Number of paracentesis for ascites (Cohort A and B)

    Time frame: Up to 8 weeks post procedure

    Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.

  12. Liver volume (Cohort A and B)

    Time frame: Up to 8 weeks post procedure

    Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.

  13. Liver function (Cohort A and B)

    Time frame: Up to 8 weeks post procedure

    Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.

  14. Nutritional status (Cohort A and B)

    Time frame: Up to 8 weeks post procedure

    Based on albumin, pre-albumin, weight, body fat, and BSA. Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.

  15. Bleeding risk (Cohort A and B)

    Time frame: Up to 8 weeks post procedure

    Based on platelet count and coagulation factors. Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua D. Kuban

CONTACT

[email protected]

713-745-0944

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Nov 16, 2020
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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