Recruiting

Portal Vein Stenting

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04629677

Conditions

Malignant Digestive System Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electronic Health Record Review

Quality-of-Life Assessment

Questionnaire Administration

Study Details

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.

Conditions

Malignant Digestive System Neoplasm

Study ID

NCT04629677

Start date

Apr 2, 2019

Status verified date

Jul, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Cohort B (medical record review)

Patients' medical records are reviewed retrospectively.

Interventions

Electronic Health Record Review

Review of medical records

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Complete questionnaires

Primary outcome measure

  • Patency rate (Cohort A) [ Time Frame: Up to 8 weeks after stent placement ]
  • Transfusion rate (Cohort A) [ Time Frame: Up to 8 weeks after stent placement ]
  • Rate of paracenteses for ascites (Cohort A) [ Time Frame: Up to 8 weeks after stent placement ]
  • Duration of clinical success (Cohort A) [ Time Frame: Up to 8 weeks after stent placement ]
  • Change in nutritional status (Cohort A) [ Time Frame: Baseline up to 30 days post procedure ]
  • Change in bleeding risk (Cohort A) [ Time Frame: Baseline up to 30 days post procedure ]
  • Change in liver function (Cohort A) [ Time Frame: Baseline up to 30 days post procedure ]
  • Change in liver volume (Cohort A) [ Time Frame: Baseline up to 30 days post procedure ]
  • Change in quality of life (QoL) (Cohort A) [ Time Frame: Baseline up to 30 days post procedure ]
  • Number of transfusions (Cohort A and B) [ Time Frame: Up to 8 weeks post procedure ]
  • Number of paracentesis for ascites (Cohort A and B) [ Time Frame: Up to 8 weeks post procedure ]
  • Liver volume (Cohort A and B) [ Time Frame: Up to 8 weeks post procedure ]
  • Liver function (Cohort A and B) [ Time Frame: Up to 8 weeks post procedure ]
  • Nutritional status (Cohort A and B) [ Time Frame: Up to 8 weeks post procedure ]
  • Bleeding risk (Cohort A and B) [ Time Frame: Up to 8 weeks post procedure ]

Central Contacts and Locations

Central contacts

Joshua D. Kuban

713-745-0944jdkuban@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Joshua D. Kuban

713-745-0944

Principal Investigator:

Joshua D. Kuban

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-21.