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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Gastrointestinal cancer patients with portal vein stenosis

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Electronic Health Record Review

    Other intervention

    Review of medical records

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Complete questionnaires

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Cohort A (questionnaire, medical record review)3 interventions
Group B: Cohort B (medical record review)1 intervention

Trial outcomes

Primary outcomes

1

Patency rate (Cohort A)

Defined by successful stent placement and described as N (%) of patients with corresponding exact 95% confidence interval.

Time frame
Up to 8 weeks after stent placement
2

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.

Time frame
Up to 8 weeks after stent placement
3

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.

Time frame
Up to 8 weeks after stent placement
4

Duration of clinical success (Cohort A)

Mean, median, standard deviation, and minimum/maximum values will be described.

Time frame
Up to 8 weeks after stent placement

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator