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

Malignant Digestive System Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04629677
• Other study ID #: PA18-0712
• Secondary ID: NCI-2020-07171PA
• Status: Recruiting
• Start date: April 2, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Joshua D. Kuban
• Phone: 713-745-0944
• Email: jdkuban[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Malignant Digestive System Neoplasm

Intervention

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

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Duration of clinical success (Cohort A)	Mean, median, standard deviation, and minimum/maximum values will be described.	Up to 8 weeks after stent placement
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   MD Anderson Cancer Center