Liver DiseasePhase 1NCT02541825
Using Covered Stent of Diameter of 7mm in TIPS
A Phase 1 study testing the stent of diameter of 7mm and the stent of diameter of 8mm in people with Liver Disease, run by Beijing Shijitan Hospital, Capital Medical University.
Trial summary
This study evaluates the incidence of hepatic encephalopathy between covered stent of diameter of 7mm and 8mm in TIPS(transjugular intrahepatic portosystemic stent shunt ).Half of the participants will receive stent of diameter of 7mm ,while the other half will receive stent of diameter of 8mm. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Disease
- What is being tested?
- the stent of diameter of 7mm and the stent of diameter of 8mm
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Dec 2017
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- there is a clear TIPS treatment indications of liver cirrhosis portal hypertension patients of gastrointestinal bleeding.
- undergoing elective TIPS to treat patients.
- aged 18-70 years old
Who cannot join
- preoperative patients with hepatic encephalopathy.
- with portal vein thrombosis patients.
- combined liver malignant tumor or other parts of the patients with malignant tumor.
- In combination of peptic ulcer bleeding.
About this study
Official title: Using Covered Stent of Diameter of 7mm in a Prospective, Single Blind, Randomized, Controlled Study of TIPS(Transjugular Intrahepatic Portosystemic Stent Shunt )
This study evaluates the incidence of hepatic encephalopathy between covered stent of diameter of 7mm and 8mm in TIPS(transjugular intrahepatic portosystemic stent shunt ).Half of the participants will receive stent of diameter of 7mm ,while the other half will receive stent of diameter of 8mm.
Read the detailed description
TIPS is effective in the treatment of hemorrhage of digestive tract and intractable ascites,which are the complications of cirrhosis. At present, the high incidence of hepatic encephalopathy has been a major problem after TIPS. The high incidence rate of hepatic encephalopathy was closly associated with the diameter of the stent. We often use the stent of diameter 8mm in TIPS.In this study, we try to use the stent of smaller diameter of 7mm in TIPS,and compare the incidence of hepatic encephalopathy between the stent of diameter of 7mm and 8mm .
- Conditions
- Liver Disease
- Being tested
- the stent of diameter of 7mm, the stent of diameter of 8mm
- Keywords
- transjugular intrahepatic portosystemic shunt
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the stent of diameter of 7mmDevice
108 patients use the stent of diameter of 7mm in TIPS
the stent of diameter of 8mmDevice
108 patients use the stent of diameter of 8mm in TIPS
| Study group | Role | What they receive |
|---|---|---|
| the stent of diameter of 7mm | Experimental | Procedure/Surgery:Jugular vein puncture and catheterization. Device:RUPS-100(COOK Company)sheath ,7mm balloon,Pigtail catheter,the stent of diameter of 7mm (Bard,Fluency) Drug(including placebo):No Biological/Vaccine:No Receives: Device: the stent of diameter of 7mm |
| the stent of diameter of 8mm | Other | Procedure/Surgery:Jugular vein puncture and catheterization. Device:RUPS-100(COOK Company)sheath ,8mm balloon,Pigtail catheter,the stent of diameter of 8mm (Bard,Fluency) Drug(including placebo):No Biological/Vaccine:No Receives: Device: the stent of diameter of 8mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hepatic encephalopathy after TIPS
The incidence of hepatic encephalopathy after TIPS in 7day,1,3,6,12month
Measured: 1 year
Secondary outcomes (7)
the incidence of shunt restenosis after TIPS
The incidence of shunt restenosis after TIPS in 7day,1,3,6,12month
Measured: 1 year
the recurrence rate of gastrointestinal bleeding after TIPS
The recurrence rate of gastrointestinal bleeding after TIPS in 7day,1,3,6,12month
Measured: 1 year
Portal venous pressure before and afterTIPS
Portal venous pressure before and afterTIPS.
Measured: 1 year
liver function in different periods
liver function during different periods before and after TIPS in 7day,1,3,6,12month
Measured: 1 year
blood ammonia in different periods
blood ammonia before and after TIPS in 7day,1,3,6,12month
Measured: 1 year
jaundice index in different periods
jaundice index before and after TIPS in 7day,1,3,6,12month
Measured: 1 year
platelet count in different periods
platelet count before and after TIPS in 7day,1,3,6,12month
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuquan Liu, Beijing Shijitan Hospital, Capital Medical University
- Investigators
- Jianli Xu, MD PhD, Study chair, Beijing Shijitan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541825
- Sponsor's protocol ID
- BeijingShijitan
- Status last verified
- Sep 2015
- First submitted
- 3 Sep 2015
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu F, Zhang K, Zhang Y, He Q, Meng M, Ma X, Zhu B, Wu Y, An L, Lv Y, Lin F, Zhang K, Liu B, Chang X, Ding H, Liu J, Chen Y, Yang Y. A 7-mm Covered TIPS Reduces Hepatic Encephalopathy Without Increasing Rebleeding in Cirrhotic Patients With Small Liver: A Randomized Study. Liver Int. 2026 Oct;46(10):e70875. doi: 10.1111/liv.70875.
PubMed 42723205
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Covered Stent of Diameter of 7mm in a Prospective, Single Blind, Randomized, Controlled Study of TIPS(Transjugular Intrahepatic Portosystemic Stent Shunt )
- ClinicalTrials.gov ID
- NCT02541825
- Acronym / sponsor ID
- BeijingShijitan
- Conditions
- Liver Disease
- Keywords
- transjugular intrahepatic portosystemic shunt
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Sep 2015 (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.
This study evaluates the incidence of hepatic encephalopathy between covered stent of diameter of 7mm and 8mm in TIPS(transjugular intrahepatic portosystemic stent shunt ).Half of the participants will receive stent of diameter of 7mm ,while the other half will receive stent of diameter of 8mm.
Detailed description
TIPS is effective in the treatment of hemorrhage of digestive tract and intractable ascites,which are the complications of cirrhosis. At present, the high incidence of hepatic encephalopathy has been a major problem after TIPS. The high incidence rate of hepatic encephalopathy was closly associated with the diameter of the stent. We often use the stent of diameter 8mm in TIPS.In this study, we try to use the stent of smaller diameter of 7mm in TIPS,and compare the incidence of hepatic encephalopathy between the stent of diameter of 7mm and 8mm .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the stent of diameter of 7mm | Experimental | Device: the stent of diameter of 7mmProcedure/Surgery:Jugular vein puncture and catheterization. Device:RUPS-100(COOK Company)sheath ,7mm balloon,Pigtail catheter,the stent of diameter of 7mm (Bard,Fluency) Drug(including placebo):No Biological/Vaccine:No |
| the stent of diameter of 8mm | Other | Device: the stent of diameter of 8mmProcedure/Surgery:Jugular vein puncture and catheterization. Device:RUPS-100(COOK Company)sheath ,8mm balloon,Pigtail catheter,the stent of diameter of 8mm (Bard,Fluency) Drug(including placebo):No Biological/Vaccine:No |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- there is a clear TIPS treatment indications of liver cirrhosis portal hypertension patients of gastrointestinal bleeding.
- undergoing elective TIPS to treat patients.
- aged 18-70 years old
Key exclusion criteria (4 listed)
- preoperative patients with hepatic encephalopathy.
- with portal vein thrombosis patients.
- combined liver malignant tumor or other parts of the patients with malignant tumor.
- In combination of peptic ulcer bleeding.
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 |
|---|---|---|
| the stent of diameter of 7mm108 patients use the stent of diameter of 7mm in TIPS | Device | the stent of diameter of 7mm |
| the stent of diameter of 8mm108 patients use the stent of diameter of 8mm in TIPS | Device | the stent of diameter of 8mm |
Primary outcome
The incidence of hepatic encephalopathy after TIPS
Time frame: 1 year
The incidence of hepatic encephalopathy after TIPS in 7day,1,3,6,12month
7 secondary outcomes
the incidence of shunt restenosis after TIPS
Time frame: 1 year
the recurrence rate of gastrointestinal bleeding after TIPS
Time frame: 1 year
Portal venous pressure before and afterTIPS
Time frame: 1 year
liver function in different periods
Time frame: 1 year
blood ammonia in different periods
Time frame: 1 year
jaundice index in different periods
Time frame: 1 year
platelet count in different periods
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
- Derived from this study: PubMed 42723205Liu F, Zhang K, Zhang Y, He Q, Meng M, Ma X, Zhu B, Wu Y, An L, Lv Y, Lin F, Zhang K, Liu B, Chang X, Ding H, Liu J, Chen Y, Yang Y. A 7-mm Covered TIPS Reduces Hepatic Encephalopathy Without Increasing Rebleeding in Cirrhotic Patients With Small Liver: A Randomized Study. Liver Int. 2026 Oct;46(10):e70875. doi: 10.1111/liv.70875.
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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.
Jianli Xu, MD PhD study chair
Beijing Shijitan Hospital, Capital Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing the stent of diameter of 7mm and the stent of diameter of 8mm in people with Liver Disease, run by Beijing Shijitan Hospital, Capital Medical University.
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 4 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 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
The incidence of hepatic encephalopathy after TIPS (time frame: 1 year). 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 NCT02541825, which also lists 1 linked publication.
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 4 Sep 2015.