Decompensated CirrhosisT8/10SVBNCT01410591
TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding
A study testing 8-mm covered stent group and 10-mm covered stent group in people with Decompensated Cirrhosis and Portal Hypertension, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The purpose of this study is to determine whether transjugular intrahepatic portosystemic shunt (TIPS) with 10-mm covered stent is associated with lower shunt dysfunction in comparing TIPS with 8-mm covered stent in cirrhotic patients with at least one episode of variceal bleeding. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Decompensated Cirrhosis, Portal Hypertension, Bleeding Varices
- What is being tested?
- 8-mm covered stent group and 10-mm covered stent group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Jan 2016
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotic patients with at least one episode of variceal bleeding
- No active bleeding within 5 days before TIPS
- Child-Pugh score ≤13
- Signed written informed consent
Who cannot join
- An age <18 years or >75 years
- With TIPS contraindications
- Past or present history of hepatic encephalopathy
- Pregnancy or breast-feeding
- Hepatic carcinoma and/or other malignancy diseases
- Sepsis
Show all 13Show fewer
- Spontaneous bacterial peritonitis
- Uncontrollable hypertension
- Serious cardiac or pulmonary dysfunction
- Renal failure
- Portal vein thrombosis
- History of organ transplantation
- History of HIV (human immunodeficiency viruses) infection
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: The Effect of TIPS With 8- or 10-mm Covered Stent for Preventing Variceal Rebleeding in Cirrhotic Patients.
The purpose of this study is to determine whether transjugular intrahepatic portosystemic shunt (TIPS) with 10-mm covered stent is associated with lower shunt dysfunction in comparing TIPS with 8-mm covered stent in cirrhotic patients with at least one episode of variceal bleeding.
- Being tested
- 8-mm covered stent group, 10-mm covered stent group
- Keywords
- transjugular intrahepatic portosystemic shunt, TIPS, liver cirrhosis, variceal bleeding, 8- or 10-mm covered stent
- Medical subject headings
- Hypertension, Portal, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-mm covered stent groupDevice
Creating a shunt between hepatic vein and portal vein with a 8-mm covered stent by TIPS procedure.
10-mm covered stent groupDevice
Creating a shunt between hepatic vein and portal vein with a 10-mm covered stent by TIPS procedure.
| Study group | Role | What they receive |
|---|---|---|
| 10-mm covered stent group | Active comparator | Patients treated with 10-mm covered stent. Receives: Device: 10-mm covered stent group |
| 8-mm covered stent group | Active comparator | Patients treated with 8-mm covered stent. Receives: Device: 8-mm covered stent group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of shunt dysfunction.
Measured: 2 years
Secondary outcomes (4)
Incidence of variceal rebleeding
Measured: 2 years
Incidence of hepatic encephalopathy
Measured: 2 years
Survival
Measured: 2 years
Incidence of hepatic myelopathy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startJul 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Decompensated CirrhosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohong Han, Air Force Military Medical University, China
- Investigators
- Guohong Han, PhD & MD, Principal investigator, Xijing Hospital of Digestive Diseases, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410591
- Sponsor's protocol ID
- T8/10CSVB
- Other IDs
- FMMU-XHDD 003
- Acronym
- T8/10SVB
- Status last verified
- Jan 2016
- First submitted
- 4 Aug 2011
- Last updated
- 26 Jan 2016
- Results posted
- No
Publications
Riggio O, Ridola L, Angeloni S, Cerini F, Pasquale C, Attili AF, Fanelli F, Merli M, Salvatori FM. Clinical efficacy of transjugular intrahepatic portosystemic shunt created with covered stents with different diameters: results of a randomized controlled trial. J Hepatol. 2010 Aug;53(2):267-72. doi: 10.1016/j.jhep.2010.02.033. Epub 2010 Apr 27.
PubMed 20537753Wang Q, Lv Y, Bai M, Wang Z, Liu H, He C, Niu J, Guo W, Luo B, Yin Z, Bai W, Chen H, Wang E, Xia D, Li X, Yuan J, Han N, Cai H, Li T, Xie H, Xia J, Wang J, Zhang H, Wu K, Fan D, Han G. Eight millimetre covered TIPS does not compromise shunt function but reduces hepatic encephalopathy in preventing variceal rebleeding. J Hepatol. 2017 Sep;67(3):508-516. doi: 10.1016/j.jhep.2017.05.006. Epub 2017 May 12.
PubMed 28506905
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of TIPS With 8- or 10-mm Covered Stent for Preventing Variceal Rebleeding in Cirrhotic Patients.
- ClinicalTrials.gov ID
- NCT01410591
- Acronym / sponsor ID
- T8/10SVB / T8/10CSVB
- Keywords
- transjugular intrahepatic portosystemic shunt, TIPS, liver cirrhosis, variceal bleeding, 8- or 10-mm covered stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Aug 2011 (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.
The purpose of this study is to determine whether transjugular intrahepatic portosystemic shunt (TIPS) with 10-mm covered stent is associated with lower shunt dysfunction in comparing TIPS with 8-mm covered stent in cirrhotic patients with at least one episode of variceal bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10-mm covered stent group | Active comparator | Device: 10-mm covered stent groupPatients treated with 10-mm covered stent. |
| 8-mm covered stent group | Active comparator | Device: 8-mm covered stent groupPatients treated with 8-mm covered stent. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cirrhotic patients with at least one episode of variceal bleeding
- No active bleeding within 5 days before TIPS
- Child-Pugh score ≤13
- Signed written informed consent
Key exclusion criteria (13 listed)
- An age <18 years or >75 years
- With TIPS contraindications
- Past or present history of hepatic encephalopathy
- Pregnancy or breast-feeding
- Hepatic carcinoma and/or other malignancy diseases
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 |
|---|---|---|
| 8-mm covered stent groupCreating a shunt between hepatic vein and portal vein with a 8-mm covered stent by TIPS procedure. | Device | 8-mm covered stent group |
| 10-mm covered stent groupCreating a shunt between hepatic vein and portal vein with a 10-mm covered stent by TIPS procedure. | Device | 10-mm covered stent group |
Primary outcome
Incidence of shunt dysfunction.
Time frame: 2 years
4 secondary outcomes
Incidence of variceal rebleeding
Time frame: 2 years
Incidence of hepatic encephalopathy
Time frame: 2 years
Survival
Time frame: 2 years
Incidence of hepatic myelopathy
Time frame: 2 years
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 26 Jan 2016.
- Background: PubMed 20537753Riggio O, Ridola L, Angeloni S, Cerini F, Pasquale C, Attili AF, Fanelli F, Merli M, Salvatori FM. Clinical efficacy of transjugular intrahepatic portosystemic shunt created with covered stents with different diameters: results of a randomized controlled trial. J Hepatol. 2010 Aug;53(2):267-72. doi: 10.1016/j.jhep.2010.02.033. Epub 2010 Apr 27.
- Derived from this study: PubMed 28506905Wang Q, Lv Y, Bai M, Wang Z, Liu H, He C, Niu J, Guo W, Luo B, Yin Z, Bai W, Chen H, Wang E, Xia D, Li X, Yuan J, Han N, Cai H, Li T, Xie H, Xia J, Wang J, Zhang H, Wu K, Fan D, Han G. Eight millimetre covered TIPS does not compromise shunt function but reduces hepatic encephalopathy in preventing variceal rebleeding. J Hepatol. 2017 Sep;67(3):508-516. doi: 10.1016/j.jhep.2017.05.006. Epub 2017 May 12.
Related trials for Decompensated Cirrhosis
Not yet recruitingObservational study
Risk Stratification for Adverse Events in End-Stage Liver Disease
Decompensated Cirrhosis
Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
RecruitingObservational study
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Ascites, Variceal Bleeding
Recruiting
Hospital @ Home Model of Care for Cirrhosis
Decompensated Cirrhosis
RecruitingObservational study
To Develop and Validate an Equation for Determination of Major Adverse Kidney Events in Patients With Decompensated Cirrhosis and Ascites.
Decompensated Cirrhosis
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.
Guohong Han, PhD & MD principal investigator
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-mm covered stent group and 10-mm covered stent group in people with Decompensated Cirrhosis and Portal Hypertension, run by Air Force Military Medical University, China 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 4 inclusion and 13 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 26 Jan 2016. 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?
Incidence of shunt dysfunction. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01410591, which also lists 2 linked publications.
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 26 Jan 2016.