Portal HypertensionNCT03094234
8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding in Patients With Child A Cirrhosis
A study testing 8mm-TIPS, endoscopic variceal ligation (EVL) 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 in patients with Child A cirrhosis 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 (EVL) and Propranolol
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2017to 28 Mar 2022
- 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 A -
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 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 procedure
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West china hospital
Chengdu
xuefeng luo, 02885422311, luo_xuefeng@yeah.net
About this study
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 in patients with Child A cirrhosis
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 (EVL), Propranolol
- 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-TIPSDevice
Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
endoscopic variceal ligation (EVL)Procedure or surgery
Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
PropranololDrug
Appropriate dose of propranolol was administered to the patients.
| 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: Device: 8mm-TIPS |
| EVL plus propranolol | Active comparator | Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment. Receives: Procedure: endoscopic variceal ligation (EVL); 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 (4)
Hepatic encephalopathy rate
Analysis
Measured: 3 years
TIPS dysfunction rate
Analysis
Measured: 3 years
The incidence of complications
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 posted29 Mar 2017
- Study start28 Apr 2017
- Primary completion28 Mar 2022 (estimated)
- Study completion28 Mar 2022 (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 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 72 participants (estimated)
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
- NCT03094234
- Sponsor's protocol ID
- 8mm-TIPS-ChildA
- Status last verified
- Nov 2021
- First submitted
- 23 Mar 2017
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Simonetti 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 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding in Patients With Child A Cirrhosis
- ClinicalTrials.gov ID
- NCT03094234
- Acronym / sponsor ID
- 8mm-TIPS-ChildA
- Conditions
- Portal Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 28 Mar 2022 (estimated)
- Study completion
- 28 Mar 2022 (estimated)
- First posted
- 29 Mar 2017 (actual)
- 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 in patients with Child A cirrhosis
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
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8mm-TIPS | Active comparator | Device: 8mm-TIPSPatients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents. |
| EVL plus propranolol | Active comparator | Procedure: endoscopic variceal ligation (EVL), 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 (1 listed)
- Cirrhosis Patients who had bled from esophageal varices (≥5days and ≤28days) Child-Pugh A -
Key exclusion criteria (2 listed)
- 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 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 procedure
- -
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-TIPSPatients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents. | Device | 8mm-TIPS |
| endoscopic variceal ligation (EVL)Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment. | Procedure or surgery | EVL plus propranolol |
| PropranololAppropriate dose of propranolol was administered to the patients. | Drug | EVL plus propranolol |
Primary outcome
Variceal rebleeding rate
Time frame: 3 years
Analysis
4 secondary outcomes
Hepatic encephalopathy rate
Time frame: 3 years
TIPS dysfunction rate
Time frame: 3 years
The incidence of complications
Time frame: 3 years
Mortality rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
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 (EVL) 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 1 inclusion and 2 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 23 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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 NCT03094234, 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 23 Nov 2021; AzTrials last refreshed its copy on 3 Nov 2026.