Gastroesophageal VaricesPhase 4NCT02638415
The Effect of Hepatic Vein Pressure Gradient(HVPG)-Guided Therapy in Cirrhotic Patients With Esophagogastric Varices
A Phase 4 study testing HVPG-guided therapy, routine therapy and Carvedilol in people with Gastroesophageal Varices and Cirrhosis, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The purpose of the study is to compare the effect of HVPG-guided individualized therapy and non-HVPG guided traditional therapy in cirrhotic patients for secondary prophylaxis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Varices, Cirrhosis
- What is being tested?
- HVPG-guided therapy, routine therapy and Carvedilol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cirrhosis diagnosed by histology, radiological evidence of cirrhosis, and endoscopic evidence of varices;
- Patients with a previous history of variceal hemorrhage;
- Patients admitted to Zhongshan Hospital and other 6 tertiary centers in Shanghai from Dec 1, 2015 to Sep 31,2018
Who cannot join
- Patients already taken secondary prophylactic treatment including endoscopic, pharmacological, surgical and interventional therapies;
- Patients with severe systemic diseases such as chronic heart failure or chronic renal failure that will have impact on survival;
- Patients in pregnancy and lactation;
- Patients already diagnosed with hepatic cellular carcinoma or other malignant tumors;
- Patients with contraindication to treatment of endoscopy, surgery and TIPS: severe coagulation defects, allergic to contrast medium used in TIPS, hepatic encephalopathy, spontaneous bacterial peritonitis;
- Patients with conditions that will influence the accuracy of HVPG measurement: Cavernous transformation of portal vein, diffused portal vein thrombosis, severe shunt;
- Patients refuse to give consent to the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Yichao Wei, Doctor, 86-13918891342, 08301010253@fudan.edu.cn
Shiyao Chen, Professor
About this study
Official title: The Effect of HVPG-Guided Individualized Therapy in Patients With Cirrhosis Related Esophagogastric Variceal Hemorrhage For Secondary Prophylaxis:A Randomized Controlled Trial
The purpose of the study is to compare the effect of HVPG-guided individualized therapy and non-HVPG guided traditional therapy in cirrhotic patients for secondary prophylaxis.
Read the detailed description
The study is a randomized controlled trial of Zelen-design. Patients randomly enter two treatment groups: 1) the HVPG group and 2) the non-HVPG group. Treatment allocation is by block randomization with an equal number for both groups. The results are concealed in opaque envelopes.After randomization, patients will have a second chance to decide if they want to stay in the current group.Patients can switch to another group according to their will. If they are in the HVPG group，they will receive HVPG measurement before treatment. If they are in the non-HVPG group, they start treatment without HVPG measurement and receive endoscopic treatment plus Carvedilol.The mortality rate and rebleeding rate will be analyzed.
- Conditions
- Gastroesophageal Varices, Cirrhosis
- Being tested
- HVPG-guided therapy, routine therapy, Carvedilol
- Keywords
- HVPG
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVPG-guided therapyProcedure or surgery
Patients with an HVPG over 20mmHg will be suggested to receive transjugular intrahepatic portocaval shunt (TIPS) or surgical shunt operation.
Patients with an HVPG between 16 and 20mmHg can choose either endoscopic treatment or TIPS according their willingness and indication.
Patients with an HVPG below 16mmHg will be treated by endoscopy plus Carvedilol, until endoscopic treatment fails.
routine therapyOther
Patients start treatment without HVPG measurement and receive endoscopic therapy plus Carvedilol.
CarvedilolDrug
Patients in HVPG group with HVPG below 16mmHg and all patients in non-HVPG group will take Carvedilol 12.5mg/d if they have no contraindications.
| Study group | Role | What they receive |
|---|---|---|
| HVPG group | Experimental | HVPG-guided therapy Receives: Procedure: HVPG-guided therapy; Drug: Carvedilol |
| non-HVPG group | Other | routine therapy Receives: Other: routine therapy; Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
The investigators observe the mortality events in both groups during the study
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Rebleeding rate
The investigators observe the rebleeding events in both groups during the study
Measured: through study completion, an average of 1 year
Adverse Events
The investigators observe any severe adverse events caused by HVPG measurement, endoscopic procedures,use of Carvedilol, surgical operations or TIPS
Measured: through study completion, an average of 1 year
Total cost
The investigators calculate the total cost of treatment of each patient during the study
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJun 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 Gastroesophageal VaricesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 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, Shanghai Pudong New Area Gongli Hospital, Eastern Hepatobiliary Surgery Hospital
- Responsible party
- Principal investigator, Shiyao Chen, Shanghai Zhongshan Hospital
- Investigators
- Shiyao Chen, Professor, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638415
- Sponsor's protocol ID
- CSY-WYC02-2015
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2015
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of HVPG-Guided Individualized Therapy in Patients With Cirrhosis Related Esophagogastric Variceal Hemorrhage For Secondary Prophylaxis:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02638415
- Acronym / sponsor ID
- CSY-WYC02-2015
- Conditions
- Gastroesophageal Varices, Cirrhosis
- Keywords
- HVPG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 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, Shanghai Pudong New Area Gongli Hospital, Eastern Hepatobiliary Surgery Hospital
- Study start
- Dec 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 23 Dec 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 the study is to compare the effect of HVPG-guided individualized therapy and non-HVPG guided traditional therapy in cirrhotic patients for secondary prophylaxis.
Detailed description
The study is a randomized controlled trial of Zelen-design. Patients randomly enter two treatment groups: 1) the HVPG group and 2) the non-HVPG group. Treatment allocation is by block randomization with an equal number for both groups. The results are concealed in opaque envelopes.After randomization, patients will have a second chance to decide if they want to stay in the current group.Patients can switch to another group according to their will. If they are in the HVPG group，they will receive HVPG measurement before treatment. If they are in the non-HVPG group, they start treatment without HVPG measurement and receive endoscopic treatment plus Carvedilol.The mortality rate and rebleeding rate will be analyzed.
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 therapy, Drug: CarvedilolHVPG-guided therapy |
| non-HVPG group | Other | Other: routine therapy, Drug: Carvedilolroutine therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with cirrhosis diagnosed by histology, radiological evidence of cirrhosis, and endoscopic evidence of varices;
- Patients with a previous history of variceal hemorrhage;
- Patients admitted to Zhongshan Hospital and other 6 tertiary centers in Shanghai from Dec 1, 2015 to Sep 31,2018
Key exclusion criteria (7 listed)
- Patients already taken secondary prophylactic treatment including endoscopic, pharmacological, surgical and interventional therapies;
- Patients with severe systemic diseases such as chronic heart failure or chronic renal failure that will have impact on survival;
- Patients in pregnancy and lactation;
- Patients already diagnosed with hepatic cellular carcinoma or other malignant tumors;
- Patients with contraindication to treatment of endoscopy, surgery and TIPS: severe coagulation defects, allergic to contrast medium used in TIPS, hepatic encephalopathy, spontaneous bacterial peritonitis;
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 therapyPatients with an HVPG over 20mmHg will be suggested to receive transjugular intrahepatic portocaval shunt (TIPS) or surgical shunt operation. Patients with an HVPG between 16 and 20mmHg can choose either endoscopic treatment or TIPS according their willingness and indication. Patients with an HVPG below 16mmHg will be treated by endoscopy plus Carvedilol, until endoscopic treatment fails. | Procedure or surgery | HVPG group |
| routine therapyPatients start treatment without HVPG measurement and receive endoscopic therapy plus Carvedilol. | Other | non-HVPG group |
| CarvedilolPatients in HVPG group with HVPG below 16mmHg and all patients in non-HVPG group will take Carvedilol 12.5mg/d if they have no contraindications. | Drug | HVPG group, non-HVPG group |
Primary outcome
Mortality rate
Time frame: through study completion, an average of 1 year
The investigators observe the mortality events in both groups during the study
3 secondary outcomes
Rebleeding rate
Time frame: through study completion, an average of 1 year
Adverse Events
Time frame: through study completion, an average of 1 year
Total cost
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
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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 principal investigator
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 HVPG-guided therapy, routine therapy and Carvedilol in people with Gastroesophageal Varices and Cirrhosis, 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 3 inclusion and 7 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 Dec 2015. 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?
Mortality rate (time frame: through study completion, an average of 1 year). 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 Dec 2015.