RecruitingNot Applicable

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

United States150 participantsStarted 2019-04-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patency rate (Cohort A)

Timeframe: Up to 8 weeks after stent placement

Transfusion rate (Cohort A)

Timeframe: Up to 8 weeks after stent placement

Rate of paracenteses for ascites (Cohort A)

Timeframe: Up to 8 weeks after stent placement

Duration of clinical success (Cohort A)

Timeframe: Up to 8 weeks after stent placement

Change in nutritional status (Cohort A)

Timeframe: Baseline up to 30 days post procedure

Change in bleeding risk (Cohort A)

Timeframe: Baseline up to 30 days post procedure

Change in liver function (Cohort A)

Timeframe: Baseline up to 30 days post procedure

Trial details

NCT IDNCT04629677

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-04-30

Contact for this trial

Joshua D. Kuban

713-745-0944 jdkuban@mdanderson.org

View on ClinicalTrials.gov More Malignant Digestive System Neoplasm trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Patency rate (Cohort A)

Timeframe: Up to 8 weeks after stent placement

Transfusion rate (Cohort A)

Timeframe: Up to 8 weeks after stent placement

Rate of paracenteses for ascites (Cohort A)

Timeframe: Up to 8 weeks after stent placement

Duration of clinical success (Cohort A)

Timeframe: Up to 8 weeks after stent placement

Change in nutritional status (Cohort A)

Timeframe: Baseline up to 30 days post procedure

Change in bleeding risk (Cohort A)

Timeframe: Baseline up to 30 days post procedure

Change in liver function (Cohort A)

Timeframe: Baseline up to 30 days post procedure