Portal HypertensionNCT02477384
8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding
A study testing 8mm-TIPS, Endoscopic variceal ligation and Propranolol in people with Portal Hypertension, run by West China Hospital at 1 site in China.
Trial summary
The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- 8mm-TIPS, Endoscopic variceal ligation and Propranolol
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jul 2021
- 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
- Cirrhosis
- Patients who had bled from esophageal varices (≥5days and ≤28days)
- Child-Pugh B or Child-Pugh C≤13
Who cannot join
- THE presence of gastric varices
- Non-cirrhotic portal hypertension
- Portal vein thrombosis
- The history of hepatic encephalopathy
- Total bilirubin ≥51.3 umol/L
- Previous treatment of TIPS or surgery
Show all 11Show fewer
- Proven malignancy including hepatocellular carcinoma
- Contraindications to TIPS、EVL or propranolol
- End-stage renal disease under renal replacement therapy;
- Cardiorespiratory failure
- Pregnancy or patients not giving informed consent for endoscopic procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Trial of 8mm Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Propranolol for Prevention of Variceal Rebleeding
The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.
Read the detailed description
For the prevention of recurrent esophageal variceal bleeding, previous clinical studies and meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt (TIPS) have lower rebleeding rates compared with endoscopic therapy. However, TIPS is associated with higher rates of portosystemic encephalopathy and does not show survival benefit. TIPS with a small-diameter may achieve sufficient portal decompression and reduce the incidence of hepatic encephalopathy. The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm ePTFE-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.
- Conditions
- Portal Hypertension
- Being tested
- 8mm-TIPS, Endoscopic variceal ligation, Propranolol, 8mm ePTFE-covered stent
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8mm-TIPSProcedure or surgery
Endoscopic variceal ligationProcedure or surgery
PropranololDrug
8mm ePTFE-covered stentDevice
| Study group | Role | What they receive |
|---|---|---|
| 8mm-TIPS | Active comparator | Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents. Receives: Procedure: 8mm-TIPS; Device: 8mm ePTFE-covered stent |
| EVL plus propranolol | Active comparator | Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment. Receives: Procedure: Endoscopic variceal ligation; Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variceal rebleeding rate
Analysis
Measured: 3 years
Secondary outcomes (6)
Hepatic encephalopathy rate
Analysis
Measured: 3 years
Number of participants with improving or worsening hepatic function
Analysis
Measured: 3 years
TIPS dysfunction rate
Analysis
Measured: 3 years
The incidence of complications
Analysis
Measured: 3 years
Number of participants with improving or worsening quality of life
Analysis
Measured: 3 years
Mortality rate
Analysis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2018
- Study completionJul 2021
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 Portal HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, luo xuefeng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477384
- Sponsor's protocol ID
- 8mm-TIPS
- Status last verified
- Nov 2021
- First submitted
- 15 Jun 2015
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang X, Liu G, Wu J, Xiao X, Yan Y, Guo Y, Yang J, Li X, He Y, Yang L, Luo X. Small-Diameter Transjugular Intrahepatic Portosystemic Shunt versus Endoscopic Variceal Ligation Plus Propranolol for Variceal Rebleeding in Advanced Cirrhosis. Radiology. 2023 Aug;308(2):e223201. doi: 10.1148/radiol.223201.
PubMed 37606572Simonetti RG, Perricone G, Robbins HL, Battula NR, Weickert MO, Sutton R, Khan S. Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD000553. doi: 10.1002/14651858.CD000553.pub3.
PubMed 33089892
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial of 8mm Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Propranolol for Prevention of Variceal Rebleeding
- ClinicalTrials.gov ID
- NCT02477384
- Acronym / sponsor ID
- 8mm-TIPS
- Conditions
- Portal Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 22 Jun 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.
The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.
Detailed description
For the prevention of recurrent esophageal variceal bleeding, previous clinical studies and meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt (TIPS) have lower rebleeding rates compared with endoscopic therapy. However, TIPS is associated with higher rates of portosystemic encephalopathy and does not show survival benefit. TIPS with a small-diameter may achieve sufficient portal decompression and reduce the incidence of hepatic encephalopathy. The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm ePTFE-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8mm-TIPS | Active comparator | Procedure: 8mm-TIPS, Device: 8mm ePTFE-covered stentPatients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents. |
| EVL plus propranolol | Active comparator | Procedure: Endoscopic variceal ligation, Drug: PropranololPatients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cirrhosis
- Patients who had bled from esophageal varices (≥5days and ≤28days)
- Child-Pugh B or Child-Pugh C≤13
Key exclusion criteria (11 listed)
- THE presence of gastric varices
- Non-cirrhotic portal hypertension
- Portal vein thrombosis
- The history of hepatic encephalopathy
- Total bilirubin ≥51.3 umol/L
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 |
|---|---|---|
| 8mm-TIPS | Procedure or surgery | 8mm-TIPS |
| Endoscopic variceal ligation | Procedure or surgery | EVL plus propranolol |
| Propranolol | Drug | EVL plus propranolol |
| 8mm ePTFE-covered stent | Device | 8mm-TIPS |
Primary outcome
Variceal rebleeding rate
Time frame: 3 years
Analysis
6 secondary outcomes
Hepatic encephalopathy rate
Time frame: 3 years
Number of participants with improving or worsening hepatic function
Time frame: 3 years
TIPS dysfunction rate
Time frame: 3 years
The incidence of complications
Time frame: 3 years
Number of participants with improving or worsening quality of life
Time frame: 3 years
Mortality rate
Time frame: 3 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 2 Dec 2021.
- Derived from this study: PubMed 37606572Wang X, Liu G, Wu J, Xiao X, Yan Y, Guo Y, Yang J, Li X, He Y, Yang L, Luo X. Small-Diameter Transjugular Intrahepatic Portosystemic Shunt versus Endoscopic Variceal Ligation Plus Propranolol for Variceal Rebleeding in Advanced Cirrhosis. Radiology. 2023 Aug;308(2):e223201. doi: 10.1148/radiol.223201.
- Derived from this study: PubMed 33089892Simonetti RG, Perricone G, Robbins HL, Battula NR, Weickert MO, Sutton R, Khan S. Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD000553. doi: 10.1002/14651858.CD000553.pub3.
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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.
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?
A study testing 8mm-TIPS, Endoscopic variceal ligation and Propranolol in people with Portal Hypertension, 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 11 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 2 Dec 2021. 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?
Variceal rebleeding rate (time frame: 3 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 NCT02477384, 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 2 Dec 2021.