Portal Vein ThrombosisNCT03031717
Clinical Course of Cirrhotic Patients With Portal Vein Thrombosis Treated With TIPS
An observational study of Portal Vein Thrombosis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Portal vein thrombosis (PVT) is defined as an obstruction of the portal vein. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients. PVT leads to increased intrahepatic resistance, decreased portal velocities, splanchnic vasodilatation, and stagnant flow. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Portal Vein Thrombosis
- What is being tested?
- Transjugular intrahepatic portosystemic shunt
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2017to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with portal vein thrombosis and with or without liver cirrhosis
Who may be able to join
- Written informed consent
- Liver cirrosis or non-cirrhotic patients
- Portal vein thrombosis (degree of vessel obstruction > 50%)
Who cannot join
- Active variceal bleeding
- Prior history of TIPS placement or shunt surgery
- Concomitant renal insufficiency
- Severe cardiopulmonary diseases
- Uncontrolled sepsis Serious medical conditions which may reduce the life expectancy
- Contraindications for TIPS
Trial locations and contacts
1 site in 1 country.
Aldo Torre Delgadillo contact
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14000
Aldo Torre Delgadillo, M.D. M.Sc, 54870900 ext. 2711, detoal@yahoo.com
Aldo Torre-Delgadillo, MD
About this study
Official title: Follow-up and Survival of Cirrhotic and Non Cirrhotic Patients With Portal Vein Thrombosis Treated With Transjugular Intrahepatic Portosystemic Shunt
Portal vein thrombosis (PVT) is defined as an obstruction of the portal vein. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients. PVT leads to increased intrahepatic resistance, decreased portal velocities, splanchnic vasodilatation, and stagnant flow.
Portal vein recanalization (PVR) with transjugular intrahepatic portosystemic shunt (TIPS) is aimed at restoring main portal vein (PV) flow in chronic PVT. In this study, we will review the safety and outcomes of this approach.
Read the detailed description
Portal vein thrombosis (PVT) is a fairly common complication of liver cirrhosis. Importantly, occlusive PVT might influence the prognosis of patients with cirrhosis. Transjugular intrahepatic portosystemic shunt (TIPS) has been reported to be an effective treatment of PVT in cirrhosis, with the advantage of avoiding the risk of bleeding linked to anticoagulation. In this study, we will evaluate the outcome of TIPS for PVT in patients with and without cirrhosis and determinate survival.
- Conditions
- Portal Vein Thrombosis
- Being tested
- Transjugular intrahepatic portosystemic shunt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transjugular intrahepatic portosystemic shuntProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome of TIPS for PVT in patients with and without cirrhosis
Clinical evolution after placement of TIPS
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Vein ThrombosisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Aldo Torre Delgadillo, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutrición Salvador ZubiranAldo Torre Delgadillo, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031717
- Sponsor's protocol ID
- TIPS-NEOPORTA
- Status last verified
- Feb 2020
- First submitted
- 23 Jan 2017
- Last updated
- 2 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up and Survival of Cirrhotic and Non Cirrhotic Patients With Portal Vein Thrombosis Treated With Transjugular Intrahepatic Portosystemic Shunt
- ClinicalTrials.gov ID
- NCT03031717
- Acronym / sponsor ID
- TIPS-NEOPORTA
- Conditions
- Portal Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- 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.
Portal vein thrombosis (PVT) is defined as an obstruction of the portal vein. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients. PVT leads to increased intrahepatic resistance, decreased portal velocities, splanchnic vasodilatation, and stagnant flow.
Portal vein recanalization (PVR) with transjugular intrahepatic portosystemic shunt (TIPS) is aimed at restoring main portal vein (PV) flow in chronic PVT. In this study, we will review the safety and outcomes of this approach.
Detailed description
Portal vein thrombosis (PVT) is a fairly common complication of liver cirrhosis. Importantly, occlusive PVT might influence the prognosis of patients with cirrhosis. Transjugular intrahepatic portosystemic shunt (TIPS) has been reported to be an effective treatment of PVT in cirrhosis, with the advantage of avoiding the risk of bleeding linked to anticoagulation. In this study, we will evaluate the outcome of TIPS for PVT in patients with and without cirrhosis and determinate survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with portal vein thrombosis and with or without liver cirrhosis
Key inclusion criteria (3 listed)
- Written informed consent
- Liver cirrosis or non-cirrhotic patients
- Portal vein thrombosis (degree of vessel obstruction > 50%)
Key exclusion criteria (6 listed)
- Active variceal bleeding
- Prior history of TIPS placement or shunt surgery
- Concomitant renal insufficiency
- Severe cardiopulmonary diseases
- Uncontrolled sepsis Serious medical conditions which may reduce the life expectancy
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 |
|---|---|---|
| Transjugular intrahepatic portosystemic shunt | Procedure or surgery | – |
Primary outcome
Outcome of TIPS for PVT in patients with and without cirrhosis
Time frame: 5 years
Clinical evolution after placement of TIPS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
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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. This study is not recruiting at the moment.
Aldo Torre Delgadillo contact
Aldo Torre Delgadillo principal investigator
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran
Aldo Torre Delgadillo principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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 Portal Vein Thrombosis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Mar 2020. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aldo Torre (54870900, detoal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome of TIPS for PVT in patients with and without cirrhosis (time frame: 5 years). 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 2 Mar 2020.