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

Recruiting

• Conditions: Malignant Digestive System Neoplasm
• Interventions: Other: Electronic Health Record Review; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT04629677
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2019-04-02
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A (questionnaire, medical record review)	Quality-of-Life Assessment	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.
Cohort A (questionnaire, medical record review)	Electronic Health 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.
Cohort A (questionnaire, medical record review)	Questionnaire Administration	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.
Cohort B (medical record review)	Electronic Health Record Review	Patients' medical records are reviewed retrospectively.

Primary Outcome Measures

Name	Time	Method
Transfusion rate (Cohort A)	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.
Change in liver volume (Cohort A)	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.
Duration of clinical success (Cohort A)	Up to 8 weeks after stent placement	Mean, median, standard deviation, and minimum/maximum values will be described.
Change in bleeding risk (Cohort A)	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.
Change in liver function (Cohort A)	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.
Change in quality of life (QoL) (Cohort A)	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.
Patency rate (Cohort A)	Up to 8 weeks after stent placement	Defined by successful stent placement and described as N (%) of patients with corresponding exact 95% confidence interval.
Nutritional status (Cohort A and B)	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.
Bleeding risk (Cohort A and B)	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.
Rate of paracenteses for ascites (Cohort A)	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.
Change in nutritional status (Cohort A)	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.
Number of transfusions (Cohort A and B)	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.
Number of paracentesis for ascites (Cohort A and B)	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.
Liver volume (Cohort A and B)	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.
Liver function (Cohort A and B)	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States