Hepatopulmonary SyndromeNCT02148536
Effect of Transjugular Intrahepatic Portosystemic Shunt on Oxygenation in Cirrhotic Patients With Hepatopulmonary Syndrome
An observational study of Hepatopulmonary Syndrome, run by West China Hospital at 1 site in China.
Trial summary
To prospectively investigate the effect of transjugular intrahepatic portosystemic shunt (TIPS) on oxygenation in cirrhotic patients with hepatopulmonary syndrome (HPS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatopulmonary Syndrome
- What is being tested?
- Transjugular intrahepatic portosystemic shunt
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Sep 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cirrhotic patients with hepatopulmonary syndrome undergoing transjugular intrahepatic portosystemic shunt for any indication at West China Hospital.
Who may be able to join
- Presence of cirrhosis
- Alveolar-arterial oxygen gradient ≥ 15 mm Hg (≥ 20 mm Hg for age > 64 years)
- Positive contrast-enhanced echocardiography
Who cannot join
- Age of less than 18 years
- Intrinsic cardiopulmonary disease
- Malignancy
- Active infection
- Pregnancy
- Previous shunt therapy
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
To prospectively investigate the effect of transjugular intrahepatic portosystemic shunt (TIPS) on oxygenation in cirrhotic patients with hepatopulmonary syndrome (HPS).
- Conditions
- Hepatopulmonary Syndrome
- Being tested
- Transjugular intrahepatic portosystemic shunt
- Medical subject headings
- Hepatopulmonary Syndrome
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
| Study group | Role | What they receive |
|---|---|---|
| HPS-TIPS group | Not described Receives: Procedure: Transjugular intrahepatic portosystemic shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar-arterial oxygen gradient (PA-a,O2)
Measured: 12 Weeks
Secondary outcomes (2)
Macroaggregated albumin (MAA) shunt fraction
Measured: 12 Weeks
Exhaled nitric oxide (eNO)
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatopulmonary SyndromeStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Li, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148536
- Sponsor's protocol ID
- WCH-2014-034
- Status last verified
- Aug 2018
- First submitted
- 21 May 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transjugular Intrahepatic Portosystemic Shunt on Oxygenation in Cirrhotic Patients With Hepatopulmonary Syndrome
- ClinicalTrials.gov ID
- NCT02148536
- Acronym / sponsor ID
- WCH-2014-034
- Conditions
- Hepatopulmonary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 28 May 2014 (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.
To prospectively investigate the effect of transjugular intrahepatic portosystemic shunt (TIPS) on oxygenation in cirrhotic patients with hepatopulmonary syndrome (HPS).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPS-TIPS group | – | Procedure: Transjugular intrahepatic portosystemic shunt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhotic patients with hepatopulmonary syndrome undergoing transjugular intrahepatic portosystemic shunt for any indication at West China Hospital.
Key inclusion criteria (3 listed)
- Presence of cirrhosis
- Alveolar-arterial oxygen gradient ≥ 15 mm Hg (≥ 20 mm Hg for age > 64 years)
- Positive contrast-enhanced echocardiography
Key exclusion criteria (7 listed)
- Age of less than 18 years
- Intrinsic cardiopulmonary disease
- Malignancy
- Active infection
- Pregnancy
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 | HPS-TIPS group |
Primary outcome
Alveolar-arterial oxygen gradient (PA-a,O2)
Time frame: 12 Weeks
2 secondary outcomes
Macroaggregated albumin (MAA) shunt fraction
Time frame: 12 Weeks
Exhaled nitric oxide (eNO)
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
Related trials for Hepatopulmonary Syndrome
Enrolling by invitationObservational study
International Registry of Congenital Portosystemic Shunt (IRCPSS)
Congenital Portosystemic Shunt, CPSS (Congenital Portosystemic Shunt)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hepatopulmonary Syndrome, run by West China Hospital at 1 site in China.
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 7 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: finished, as of the sponsor's last update on 31 Aug 2018. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar-arterial oxygen gradient (PA-a,O2) (time frame: 12 Weeks). 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 31 Aug 2018.