Liver CirrhosisPhase 4NCT02695732
The Effect of Carvedilol VS Endoscopic Therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding
A Phase 4 study testing Carvedilol and endoscopy in people with Liver Cirrhosis and Esophageal and Gastric Varices, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis, Esophageal and Gastric Varices
- What is being tested?
- Carvedilol and endoscopy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 792 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Sep 2018
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the presence of severe esophageal and gastric varices at upper gastrointestinal endoscopy without a previous haemorrhage
- a diagnosis of liver cirrhosis based on histology, clinical or imaging manifestation
Who cannot join
- age greater than 80 years old or younger than 18 years old
- non-cirrhotic portal hypertension
- contraindications to NSBB including bronchospasm, severe bradycardia, severe heart failure, acute pulmonary edema, atrioventricular block and so on
- ABPsys less than 95 mmHg or HR less than 50 bpm
- prior treatment for prevention of bleeding from EGV
- presence of spontaneous bacterial peritonitis or other severe infections
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- presence of hepatorenal syndrome
- uncontrolled hepatic encephalopathy
- presence of refractory ascites
- pregnancy
- presence of portosystemic shunt or portal cavernous transformation
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai
Chu Liu, doctor, 86-15201928343, 09301010159@fudan.edu.cn
Shiyao Chen, professor
About this study
Official title: Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding Comparing Carvedilol and Endoscopic Therapy: A Multicenter Randomized Controlled Trial
To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding.
Read the detailed description
The study is a randomized controlled trial. Patients randomly enter into two treatment groups: 1)the Carvedilol group and 2)the endoscopy group. Treatment allocation is by block randomization, with an two-to-one ratio for Carvedilol and endoscopy. The results are concealed in opaque envelopes. The dose of Carvedilol is titrated according to systolic arterial blood pressure (ABPsys) and heart rate (HR). Doses are increased every 7 days until ABPsys is not less than 95 mm Hg and HR is not less than 55 bpm. Carvedilol is started at a dose of 6.25 mg/d, and titrated to a maximum dose of 12.5 mg/d. Patients receiving endoscopic therapy every 4 weeks until eradication of varices. Patients will come for clinic visit every 6 months, receiving laboratory tests and endoscopic examinations, and events of primary and secondary outcomes will be analyzed.
- Conditions
- Liver Cirrhosis, Esophageal and Gastric Varices
- Being tested
- Carvedilol, endoscopy
- Keywords
- Esophageal and Gastric Varices, Primary Prophylaxis, Carvedilol, Endoscopy
- Medical subject headings
- Liver Cirrhosis, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Also called JinLuo, LvDao
Carvedilol is started at a dose of 6.25 mg/d, and titrated to a maximum dose of 12.5 mg/d.Doses are increased every 7 days until ABPsys is not less than 95 mm Hg and HR is not less than 55 bpm.
endoscopyDevice
Patients receiving endoscopic therapy (either endoscopic ligation or cyanoacrylate injection) every 4 weeks until eradication of varices.
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol | Experimental | Carvedilol，6.25mg-12.5mg/d,oral,6-36 months Receives: Drug: Carvedilol |
| endoscopy | Active comparator | endoscopy，every 4 weeks until eradication of varices Receives: Device: endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding rate
The investigators observe the variceal bleeding events during the study
Measured: through study completion，an average of 18 months
Secondary outcomes (2)
Mortality rate
The investigators observe the mortality events during the study due to variceal bleeding, hepatic encephalopathy, liver failure, hepatic cellular carcinoma, hepatic-renal syndrome and spontaneous bacterial peritonitis.
Measured: through study completion，an average of 18 months
Adverse events
The investigators observe any severe adverse events caused by drug or endoscopic treatment.
Measured: through study completion，an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 792 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, ShuGuang Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Gongli Hospital, School of Medicine, The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital
- Responsible party
- Principal investigator, Shiyao Chen, Shanghai Zhongshan Hospital
- Investigators
- Shiyao Chen, Professor, Study director, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695732
- Sponsor's protocol ID
- CSY-LC02-2016
- Status last verified
- Feb 2016
- First submitted
- 25 Feb 2016
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding Comparing Carvedilol and Endoscopic Therapy: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02695732
- Acronym / sponsor ID
- CSY-LC02-2016
- Conditions
- Liver Cirrhosis, Esophageal and Gastric Varices
- Keywords
- Esophageal and Gastric Varices, Primary Prophylaxis, Carvedilol, Endoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 792 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, ShuGuang Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Gongli Hospital, School of Medicine, The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital
- Study start
- Dec 2015
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 1 Mar 2016 (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.
To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding.
Detailed description
The study is a randomized controlled trial. Patients randomly enter into two treatment groups: 1)the Carvedilol group and 2)the endoscopy group. Treatment allocation is by block randomization, with an two-to-one ratio for Carvedilol and endoscopy. The results are concealed in opaque envelopes. The dose of Carvedilol is titrated according to systolic arterial blood pressure (ABPsys) and heart rate (HR). Doses are increased every 7 days until ABPsys is not less than 95 mm Hg and HR is not less than 55 bpm. Carvedilol is started at a dose of 6.25 mg/d, and titrated to a maximum dose of 12.5 mg/d. Patients receiving endoscopic therapy every 4 weeks until eradication of varices. Patients will come for clinic visit every 6 months, receiving laboratory tests and endoscopic examinations, and events of primary and secondary outcomes will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carvedilol | Experimental | Drug: CarvedilolCarvedilol，6.25mg-12.5mg/d,oral,6-36 months |
| endoscopy | Active comparator | Device: endoscopyendoscopy，every 4 weeks until eradication of varices |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the presence of severe esophageal and gastric varices at upper gastrointestinal endoscopy without a previous haemorrhage
- a diagnosis of liver cirrhosis based on histology, clinical or imaging manifestation
Key exclusion criteria (12 listed)
- age greater than 80 years old or younger than 18 years old
- non-cirrhotic portal hypertension
- contraindications to NSBB including bronchospasm, severe bradycardia, severe heart failure, acute pulmonary edema, atrioventricular block and so on
- ABPsys less than 95 mmHg or HR less than 50 bpm
- prior treatment for prevention of bleeding from EGV
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 |
|---|---|---|
| CarvedilolAlso: JinLuo, LvDaoCarvedilol is started at a dose of 6.25 mg/d, and titrated to a maximum dose of 12.5 mg/d.Doses are increased every 7 days until ABPsys is not less than 95 mm Hg and HR is not less than 55 bpm. | Drug | Carvedilol |
| endoscopyPatients receiving endoscopic therapy (either endoscopic ligation or cyanoacrylate injection) every 4 weeks until eradication of varices. | Device | endoscopy |
Primary outcome
Bleeding rate
Time frame: through study completion，an average of 18 months
The investigators observe the variceal bleeding events during the study
2 secondary outcomes
Mortality rate
Time frame: through study completion，an average of 18 months
Adverse events
Time frame: through study completion，an average of 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
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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.
Shiyao Chen, Professor study director
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carvedilol and endoscopy in people with Liver Cirrhosis and Esophageal and Gastric Varices, run by Shanghai Zhongshan 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 2 inclusion and 12 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 1 Mar 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shiyao Chen, Professor (86-13601767310, chen.shiyao@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding rate (time frame: through study completion，an average of 18 months). 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 1 Mar 2016.