Malignant Digestive System NeoplasmNCT04629677
Evaluation of Portal Vein Stenting in Patients With Portal Vein Stenosis and Gastrointestinal Cancers
An observational study of Malignant Digestive System Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Digestive System Neoplasm
- What is being tested?
- Electronic Health Record Review, Quality-of-Life Assessment and Questionnaire Administration
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2019to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gastrointestinal cancer patients with portal vein stenosis
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Joshua D. Kuban, 713-745-0944
Joshua D. Kuban
About this study
Official title: Prospective Evaluation of Portal Vein (PV) Stenting in Patients With PV Stenosis and Gastrointestinal Malignancies
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Malignant Digestive System Neoplasm
- Being tested
- Electronic Health Record Review, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Review of medical records
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electronic Health Record Review; Other: Quality-of-Life Assessment; Other: Questionnaire Administration | |
| Cohort B (medical record review) | Patients' medical records are reviewed retrospectively. Receives: Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency rate (Cohort A)
Defined by successful stent placement and described as N (%) of patients with corresponding exact 95% confidence interval.
Measured: Up to 8 weeks after stent placement
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.
Measured: Up to 8 weeks after stent placement
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.
Measured: Up to 8 weeks after stent placement
Duration of clinical success (Cohort A)
Mean, median, standard deviation, and minimum/maximum values will be described.
Measured: Up to 8 weeks after stent placement
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.
Measured: Baseline up to 30 days post procedure
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.
Measured: Baseline up to 30 days post procedure
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.
Measured: Baseline up to 30 days post procedure
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.
Measured: Baseline up to 30 days post procedure
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.
Measured: Baseline up to 30 days post procedure
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.
Measured: Up to 8 weeks post procedure
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.
Measured: Up to 8 weeks post procedure
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.
Measured: Up to 8 weeks post procedure
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.
Measured: Up to 8 weeks post procedure
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.
Measured: Up to 8 weeks post procedure
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.
Measured: Up to 8 weeks post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start2 Apr 2019
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Digestive System NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joshua D Kuban, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629677
- Sponsor's protocol ID
- PA18-0712
- Other IDs
- NCI-2020-07171, PA18-0712
- Status last verified
- Jul 2026
- First submitted
- 9 Nov 2020
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Portal Vein (PV) Stenting in Patients With PV Stenosis and Gastrointestinal Malignancies
- ClinicalTrials.gov ID
- NCT04629677
- Acronym / sponsor ID
- PA18-0712
- Conditions
- Malignant Digestive System Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (questionnaire, medical record review) | – | Other: Electronic Health Record Review, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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) | – | Other: Electronic Health Record ReviewPatients' medical records are reviewed retrospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gastrointestinal cancer patients with portal vein stenosis
Key inclusion criteria (4 listed)
- 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:
- COHORT B: Patients who have thrombosis/stenosis of the main portal vein but who did not undergo stenting
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Health Record ReviewReview of medical records | Other | Cohort A (questionnaire, medical record review), Cohort B (medical record review) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Cohort A (questionnaire, medical record review) |
| Questionnaire AdministrationComplete questionnaires | Other | Cohort A (questionnaire, medical record review) |
Primary outcome
Patency rate (Cohort A)
Time frame: Up to 8 weeks after stent placement
Defined by successful stent placement and described as N (%) of patients with corresponding exact 95% confidence interval.
Transfusion rate (Cohort A)
Time frame: 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.
Rate of paracenteses for ascites (Cohort A)
Time frame: 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.
Duration of clinical success (Cohort A)
Time frame: Up to 8 weeks after stent placement
Mean, median, standard deviation, and minimum/maximum values will be described.
Change in nutritional status (Cohort A)
Time frame: 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.
Change in bleeding risk (Cohort A)
Time frame: 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)
Time frame: 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 liver volume (Cohort A)
Time frame: 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)
Time frame: 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.
Number of transfusions (Cohort A and B)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Nutritional status (Cohort A and B)
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua D Kuban principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Digestive System Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua D. Kuban (713-745-0944, jdkuban@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency rate (Cohort A) (time frame: Up to 8 weeks after stent placement). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.