Gastric VaricesNCT02468206
Secondary Prophylaxis of Gastric Variceal Bleed
A study testing Balloon-occluded retrograde transvenous obliteration, Endoscopic cyanoacrylate injection and N-butyl-2-cyanoacrylate in people with Gastric Varices, run by West China Hospital at 1 site in China.
Trial summary
The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal rebleeding and improvement in survival. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Varices
- What is being tested?
- Balloon-occluded retrograde transvenous obliteration, Endoscopic cyanoacrylate injection and N-butyl-2-cyanoacrylate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to 7 Jan 2019
- 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 GOV2 or IGV1（≥5 days and ≤ 28days）
- Presence of gastrorenal shunt
Who cannot join
- Previous treatment of gastric varices, including endoscopic therapy, NSBB, TIPS, or surgery
- Non-cirrhotic portal hypertension
- Contraindications to cyanoacrylate injection or BRTO
- Portal cavernoma
- Hepatorenal syndrome
- Proven malignancy including hepatocellular carcinoma
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- 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: Endoscopic Cyanoacrylate Injection vs. Balloon-occluded Retrograde Transvenous Obliteration in the Prevention of Gastric Variceal Rebleeding
The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal rebleeding and improvement in survival.
- Conditions
- Gastric Varices
- Being tested
- Balloon-occluded retrograde transvenous obliteration, Endoscopic cyanoacrylate injection, N-butyl-2-cyanoacrylate, Lauromacrogol
- Medical subject headings
- Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon-occluded retrograde transvenous obliterationProcedure or surgery
Balloon-occluded retrograde transvenous obliteration
Endoscopic cyanoacrylate injectionProcedure or surgery
Endoscopic cyanoacrylate injection
N-butyl-2-cyanoacrylateDrug
LauromacrogolDrug
| Study group | Role | What they receive |
|---|---|---|
| BRTO | Active comparator | Balloon-occluded retrograde transvenous obliteration Receives: Procedure: Balloon-occluded retrograde transvenous obliteration; Drug: Lauromacrogol |
| NBCA | Active comparator | Endoscopic Cyanoacrylate injection in the gastric varix Receives: Procedure: Endoscopic cyanoacrylate injection; Drug: N-butyl-2-cyanoacrylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding rate from gastric varices
Measured: 3 years
Secondary outcomes (9)
Eradication rate of gastric varices
Measured: 3 years
Number of participants with increase or decrease in the size of gastric varices
Measured: 3 years
Number of participants with appearance or worsening of new oesophageal varices
Measured: 3 years
Number of participants with appearance or worsening of portal hypertensive gastropathy
Measured: 3 years
Number of participants with appearance or worsening of ascites
Measured: 3 years
Number of participants with complication
Measured: 3 years
Average in-hospital stay
Measured: 3 years
Cost of treatment
Measured: 3 years
Mortality rate
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 posted10 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion28 Feb 2018
- Study completion7 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric VaricesStudies 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
- Outcomes assessor
- Enrolment
- 64 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
- NCT02468206
- Sponsor's protocol ID
- BRTO-NBCA-SP
- Status last verified
- Jan 2019
- First submitted
- 3 Jun 2015
- Last updated
- 8 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Cyanoacrylate Injection vs. Balloon-occluded Retrograde Transvenous Obliteration in the Prevention of Gastric Variceal Rebleeding
- ClinicalTrials.gov ID
- NCT02468206
- Acronym / sponsor ID
- BRTO-NBCA-SP
- Conditions
- Gastric Varices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 10 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 purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal rebleeding and improvement in survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRTO | Active comparator | Procedure: Balloon-occluded retrograde transvenous obliteration, Drug: LauromacrogolBalloon-occluded retrograde transvenous obliteration |
| NBCA | Active comparator | Procedure: Endoscopic cyanoacrylate injection, Drug: N-butyl-2-cyanoacrylateEndoscopic Cyanoacrylate injection in the gastric varix |
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 GOV2 or IGV1（≥5 days and ≤ 28days）
- Presence of gastrorenal shunt
Key exclusion criteria (9 listed)
- Previous treatment of gastric varices, including endoscopic therapy, NSBB, TIPS, or surgery
- Non-cirrhotic portal hypertension
- Contraindications to cyanoacrylate injection or BRTO
- Portal cavernoma
- Hepatorenal syndrome
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 |
|---|---|---|
| Balloon-occluded retrograde transvenous obliterationBalloon-occluded retrograde transvenous obliteration | Procedure or surgery | BRTO |
| Endoscopic cyanoacrylate injectionEndoscopic cyanoacrylate injection | Procedure or surgery | NBCA |
| N-butyl-2-cyanoacrylate | Drug | NBCA |
| Lauromacrogol | Drug | BRTO |
Primary outcome
Rebleeding rate from gastric varices
Time frame: 3 years
9 secondary outcomes
Eradication rate of gastric varices
Time frame: 3 years
Number of participants with increase or decrease in the size of gastric varices
Time frame: 3 years
Number of participants with appearance or worsening of new oesophageal varices
Time frame: 3 years
Number of participants with appearance or worsening of portal hypertensive gastropathy
Time frame: 3 years
Number of participants with appearance or worsening of ascites
Time frame: 3 years
Number of participants with complication
Time frame: 3 years
Average in-hospital stay
Time frame: 3 years
Cost of treatment
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 8 Jan 2019.
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Esophageal Varices
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 Balloon-occluded retrograde transvenous obliteration, Endoscopic cyanoacrylate injection and N-butyl-2-cyanoacrylate in people with Gastric Varices, 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 9 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 8 Jan 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?
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?
Rebleeding rate from gastric varices (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 8 Jan 2019.