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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Digestive System Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Electronic Health Record Review

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Joshua D. Kuban; Phone Number: 713-745-0944; Email: jdkuban@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Joshua D. Kuban; Phone Number: 713-745-0944
      • Principal Investigator: Joshua D. Kuban

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Gastrointestinal cancer patients with portal vein stenosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A (questionnaire, medical record review); Patients complete a QoL questionnaire at 2-4 weeks and then 6-8 weeks after portal vein stenting procedure. Patients' medical records are also reviewed.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Complete questionnaires; Other: Electronic Health Record Review; Review of medical records
Cohort B (medical record review); Patients' medical records are reviewed retrospectively.	Other: Electronic Health Record Review; Review of medical records

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patency rate (Cohort A)	Defined by successful stent placement and described as N (%) of patients with corresponding exact 95% confidence interval.	Up to 8 weeks after stent placement
Transfusion rate (Cohort A)	N (%) of patients receiving transfusion with corresponding exact 95% confidence interval. Instances of multiple transfusions per patient will also be described.	Up to 8 weeks after stent placement
Rate of paracenteses for ascites (Cohort A)	N (%) of patients receiving paracenteses with corresponding exact 95% confidence interval. Instances of multiple paracenteses per patient will also be described.	Up to 8 weeks after stent placement
Duration of clinical success (Cohort A)	Mean, median, standard deviation, and minimum/maximum values will be described.	Up to 8 weeks after stent placement
Change in nutritional status (Cohort A)	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.	Baseline up to 30 days post procedure
Change in bleeding risk (Cohort A)	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.	Baseline up to 30 days post procedure
Change in liver function (Cohort A)	Methods such as repeated measures ANOVA with post-hoc Tukey test and GEE will be used to assess pre- and post- differences.	Baseline up to 30 days post procedure
Change in liver volume (Cohort A)	Methods such as repeated measures ANOVA with post-hoc Tukey test and GEE will be used to assess pre- and post- differences.	Baseline up to 30 days post procedure
Change in quality of life (QoL) (Cohort A)	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.	Baseline up to 30 days post procedure
Number of transfusions (Cohort A and B)	Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.	Up to 8 weeks post procedure
Number of paracentesis for ascites (Cohort A and B)	Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.	Up to 8 weeks post procedure
Liver volume (Cohort A and B)	Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.	Up to 8 weeks post procedure
Liver function (Cohort A and B)	Methods such as paired t-tests, conditional logistic regression, and generalized linear modeling will be used to compare differences by cohort.	Up to 8 weeks post procedure
Nutritional status (Cohort A and B)	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.	Up to 8 weeks post procedure
Bleeding risk (Cohort A and B)	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.	Up to 8 weeks post procedure

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Joshua D Kuban, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: PA18-0712 (Other Identifier: M D Anderson Cancer Center); NCI-2020-07171 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No