Liver CirrhosesNCT03171805
The Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices
A study testing Propranolol in people with Liver Cirrhoses and Portal Hypertension, run by West China Hospital at 1 site in China.
Trial summary
Balloon-occluded retrograde transvenous obliteration (BRTO) has been effective method to manage gastric varices. However, more than one third of patients after BRTO treatment experienced worsening of esophageal varices. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhoses, Portal Hypertension, Gastric Varix
- What is being tested?
- Propranolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 30 Dec 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
- Clinical diagnosis of liver cirrhosis
- Clinical diagnosis of isolated gastric varices
- The presenec of spontaneous portosystemic shunt
Who cannot join
- Contradictions to Propranolol
- Balloon occluded retrograde transvenous obliteration was failed
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
Official title: Post-balloon Occluded Retrograde Transvenous Obliteration Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices
Balloon-occluded retrograde transvenous obliteration (BRTO) has been effective method to manage gastric varices. However, more than one third of patients after BRTO treatment experienced worsening of esophageal varices. The present study was designed to evaluate the effect of post-BRTO propranolol adminstration on the change of esophageal varices.
- Conditions
- Liver Cirrhoses, Portal Hypertension, Gastric Varix
- Being tested
- Propranolol
- Medical subject headings
- Hypertension, Portal, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Propranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol group | Experimental | Propranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully. Receives: Drug: Propranolol |
| control group | No intervention | Propranolol was not given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worsening of esophageal varices rate
Analysis
Measured: 3 years
Secondary outcomes (3)
Variceal rebleeding rate
Analysis
Measured: 3 years
Mortality rate
Analysis
Measured: 3 years
Worsening of ascites 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 posted31 May 2017
- Study start1 Jun 2017
- Primary completion15 May 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosesStudies 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
- 74 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
- Investigators
- xuefeng luo, Principal investigator, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171805
- Sponsor's protocol ID
- Propranolol in GV
- Status last verified
- Nov 2021
- First submitted
- 26 May 2017
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Post-balloon Occluded Retrograde Transvenous Obliteration Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices
- ClinicalTrials.gov ID
- NCT03171805
- Acronym / sponsor ID
- Propranolol in GV
- Conditions
- Liver Cirrhoses, Portal Hypertension, Gastric Varix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 15 May 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 31 May 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.
Balloon-occluded retrograde transvenous obliteration (BRTO) has been effective method to manage gastric varices. However, more than one third of patients after BRTO treatment experienced worsening of esophageal varices. The present study was designed to evaluate the effect of post-BRTO propranolol adminstration on the change of esophageal varices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol group | Experimental | Drug: PropranololPropranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully. |
| control group | No intervention | –Propranolol was not given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of liver cirrhosis
- Clinical diagnosis of isolated gastric varices
- The presenec of spontaneous portosystemic shunt
Key exclusion criteria (2 listed)
- Contradictions to Propranolol
- Balloon occluded retrograde transvenous obliteration was failed
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 |
|---|---|---|
| PropranololPropranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully. | Drug | Propranolol group |
Primary outcome
Worsening of esophageal varices rate
Time frame: 3 years
Analysis
3 secondary outcomes
Variceal rebleeding rate
Time frame: 3 years
Mortality rate
Time frame: 3 years
Worsening of ascites 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.
- 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.
xuefeng luo principal investigator
Sichuan 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 Propranolol in people with Liver Cirrhoses and 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 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?
Contact xuefeng luo (02885422311, luo_xuefeng@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worsening of esophageal varices 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?
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.