Esophageal Varices in Cirrhosis of the LiverNCT03687216
HVPG-Guided Therapy Versus EVL Plus NSBB in Second Prophylaxis of Esophageal Variceal Bleeding
A study testing HVPG-guided therapy and Routing Therapy in people with Esophageal Varices in Cirrhosis of the Liver, run by West China Hospital at 1 site in China.
Trial summary
A single-center randomized controlled study comparing endoscopic or interventional therapy guided by the hepatic venous pressure gradient (HVPG) , to standard endosopic variceal ligation plus nonselective beta-blocker therapy (NSBB) in patients with esophageal varices due to liver cirrhosis with a history of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Varices in Cirrhosis of the Liver
- What is being tested?
- HVPG-guided therapy and Routing Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Sep 2019to Dec 2020
- 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
- Liver cirrhosis diagnosed by clinical examination, imaging or biopsy;
- A previous history of variceal hemorrhage;
- Written informed consent.
Who cannot join
- Previous history of secondary prophylactic treatment;
- Contraindications to treatment of endoscopy, surgery and TIPS
- Severe cardiac, pulmonary or renal dysfunction;
- Lactating or pregnant;
- Malignancies;
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital
Chengdu, Sichuan, 610041
Li Yang, +8618980601276, yangli_hx@scu.edu.cn
About this study
Official title: A Single-center Randomized Controlled Study of Secondary Prophylaxis of Cirrhosis Related Esophagogastric Variceal Hemorrhage Treated With HVPG-guided Therapy or Standard Esophageal Variceal Ligation Plus Beta-blocker
A single-center randomized controlled study comparing endoscopic or interventional therapy guided by the hepatic venous pressure gradient (HVPG) , to standard endosopic variceal ligation plus nonselective beta-blocker therapy (NSBB) in patients with esophageal varices due to liver cirrhosis with a history of esophageal variceal hemorrhage.Primary study outcome of the study is variceal rebleeding episodes occurring within the first years after interventions. Second study outcomes of the study are hepatic encephalopathy occurrence, mortality occurrence, liver transplantation or other cirrhosis-related complications.
- Being tested
- HVPG-guided therapy, Routing Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVPG-guided therapyProcedure or surgery
The baseline HVPG measurement is performed. According to the result, patients with an HVPG over 20 mmHg will be receive transjugular intrahepatic portocaval shunt (TIPS) .
Patients with an HVPG below 20 mmHg will be treated by endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol until treatment fails.
Routing TherapyProcedure or surgery
Without HVPG measurement, patients receive endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol.
| Study group | Role | What they receive |
|---|---|---|
| HVPG group | Experimental | HVPG-guided therapy (TIPS or EVL plus NSBB according to HVPG) Receives: Procedure: HVPG-guided therapy |
| Routing group | Active comparator | Routing therapy (EVL plus NSBB) Receives: Procedure: Routing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variceal rebleeding rate
The incidence of clinically significant gastrointestinal variceal bleeding
Measured: One year of follow-up
Secondary outcomes (4)
Hepatic encephalopathy: The incidence of hepatic encephalopathy
The incidence of hepatic encephalopathy
Measured: One year of follow-up
Ascites: The incidence of ascites detected by ultrasound
The incidence of ascites detected by ultrasound
Measured: One year of follow-up
Cirrhotic complications
portal vein thrombosis, liver dysfunction, hepatorenal syndrome et al.
Measured: One year of follow-up
Liver transplant-free survivial
Time from the procedure to the date of lost-to-follow-up or death or liver transplant
Measured: One year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study startSep 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Varices in Cirrhosis of the LiverStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Yang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687216
- Sponsor's protocol ID
- HGT-EN
- Status last verified
- Mar 2019
- First submitted
- 20 Sep 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Randomized Controlled Study of Secondary Prophylaxis of Cirrhosis Related Esophagogastric Variceal Hemorrhage Treated With HVPG-guided Therapy or Standard Esophageal Variceal Ligation Plus Beta-blocker
- ClinicalTrials.gov ID
- NCT03687216
- Acronym / sponsor ID
- HGT-EN
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 27 Sep 2018 (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.
A single-center randomized controlled study comparing endoscopic or interventional therapy guided by the hepatic venous pressure gradient (HVPG) , to standard endosopic variceal ligation plus nonselective beta-blocker therapy (NSBB) in patients with esophageal varices due to liver cirrhosis with a history of esophageal variceal hemorrhage.Primary study outcome of the study is variceal rebleeding episodes occurring within the first years after interventions. Second study outcomes of the study are hepatic encephalopathy occurrence, mortality occurrence, liver transplantation or other cirrhosis-related complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HVPG group | Experimental | Procedure: HVPG-guided therapyHVPG-guided therapy (TIPS or EVL plus NSBB according to HVPG) |
| Routing group | Active comparator | Procedure: Routing TherapyRouting therapy (EVL plus NSBB) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Liver cirrhosis diagnosed by clinical examination, imaging or biopsy;
- A previous history of variceal hemorrhage;
- Written informed consent.
Key exclusion criteria (5 listed)
- Previous history of secondary prophylactic treatment;
- Contraindications to treatment of endoscopy, surgery and TIPS
- Severe cardiac, pulmonary or renal dysfunction;
- Lactating or pregnant;
- Malignancies;
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 |
|---|---|---|
| HVPG-guided therapyThe baseline HVPG measurement is performed. According to the result, patients with an HVPG over 20 mmHg will be receive transjugular intrahepatic portocaval shunt (TIPS) . Patients with an HVPG below 20 mmHg will be treated by endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol until treatment fails. | Procedure or surgery | HVPG group |
| Routing TherapyWithout HVPG measurement, patients receive endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol. | Procedure or surgery | Routing group |
Primary outcome
Variceal rebleeding rate
Time frame: One year of follow-up
The incidence of clinically significant gastrointestinal variceal bleeding
4 secondary outcomes
Hepatic encephalopathy: The incidence of hepatic encephalopathy
Time frame: One year of follow-up
Ascites: The incidence of ascites detected by ultrasound
Time frame: One year of follow-up
Cirrhotic complications
Time frame: One year of follow-up
Liver transplant-free survivial
Time frame: One year of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No
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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 HVPG-guided therapy and Routing Therapy in people with Esophageal Varices in Cirrhosis of the Liver, 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 5 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 13 Mar 2019. 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: One year of follow-up). 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 13 Mar 2019.