Liver CirrhosisSILCNCT04850534
Systemic Inflammation in Liver Cirrhosis
An observational study of Liver Cirrhosis, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Investigate systemic inflammation in liver cirrhosis patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 30 Oct 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients of liver cirrhosis with high-risk bleeding esophaogastric varices
Who may be able to join
- Decompensated liver cirrhosis, with endoscopy-verified high-risk esophagogastric varices;
- Adult patients aged 18-75 years;
- Willing to anticipate and informed consent form obtained
Who cannot join
- History of prior radio-interventional therapy (TIPS or BRTO), liver transplantation, splenectomy, or hepatectomy;
- Non-sinusoidal cirrhosis (e.g. vascular cirrhosis);
- Coexistence with advanced hepatocellular carcinoma or other malignancies;
- Coexistence with severe systemic diseases and less than 3 months of expected survival time;
- Acute infection within 4 weeks before recruitment;
- Antibiotic use within 4 weeks before recruitment;
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- Initial antiviral therapy for HBV or HCV within 4 weeks before recruitment;
- Pregnant or lactating women;
- Patients resistant to long-term follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiology, the Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: Evaluation and Prognostic Indications of Systemic Inflammation in Liver Cirrhosis Patients
Investigate systemic inflammation in liver cirrhosis patients
- Conditions
- Liver Cirrhosis
- Keywords
- Liver cirrhosis; Systemic inflammation
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EGD+NSBB | Patients receiving both endoscopic therapy and non-selective beta-blockers for treating high-risk esophagogastric varices | |
| EGD | Patients receiving mono endoscopic therapy for treating high-risk esophagogastric varices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Gastrointestinal Bleeding
Overt upper GI bleeding due to esophagogastric varices, ulcers and other causes; Identified by clinical manifestations, lab tests and endoscopy and measured by number/proportion of patients
Measured: One Year
Death
Deaths caused by variceal bleeding, hepatocellular carcinoma, liver failure, etc
Measured: One Year
Secondary outcomes (2)
New or worsening acute decompensation event other than upper GI bleeding
Ascites, Hepatic encephalopathy, systemic infection, spontaneous bacterial peritonitis, hepatorenal syndrome, etc Identified by clinical manifestations, lab tests and images according to renown practice guidelines and measured by number/proportion of patients
Measured: One Year
Liver transplantation/ Transfer to other non-endoscopic therapies
Undergo liver transplantation, or transferred to surgical, radio-interventional, or other non-endoscopic therapies; Measured by number/proportion of patients
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Apr 2019
- Primary completion31 Dec 2022
- Study completion30 Oct 2023
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Jinlai Liu, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Bin Wu, Ph.D, Principal investigator, Department of Gastroenterology, Third Affiliated Hospital of Sun Yar-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850534
- Sponsor's protocol ID
- SILC
- Acronym
- SILC
- Status last verified
- Dec 2023
- First submitted
- 18 Apr 2021
- Last updated
- 6 Dec 2023
- Results posted
- 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 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Prognostic Indications of Systemic Inflammation in Liver Cirrhosis Patients
- ClinicalTrials.gov ID
- NCT04850534
- Acronym / sponsor ID
- SILC / SILC
- Conditions
- Liver Cirrhosis
- Keywords
- Liver cirrhosis; Systemic inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 20 Apr 2021 (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.
Investigate systemic inflammation in liver cirrhosis patients
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGD+NSBB | – | –Patients receiving both endoscopic therapy and non-selective beta-blockers for treating high-risk esophagogastric varices |
| EGD | – | –Patients receiving mono endoscopic therapy for treating high-risk esophagogastric varices |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of liver cirrhosis with high-risk bleeding esophaogastric varices
Key inclusion criteria (3 listed)
- Decompensated liver cirrhosis, with endoscopy-verified high-risk esophagogastric varices;
- Adult patients aged 18-75 years;
- Willing to anticipate and informed consent form obtained
Key exclusion criteria (9 listed)
- History of prior radio-interventional therapy (TIPS or BRTO), liver transplantation, splenectomy, or hepatectomy;
- Non-sinusoidal cirrhosis (e.g. vascular cirrhosis);
- Coexistence with advanced hepatocellular carcinoma or other malignancies;
- Coexistence with severe systemic diseases and less than 3 months of expected survival time;
- Acute infection within 4 weeks before recruitment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Upper Gastrointestinal Bleeding
Time frame: One Year
Overt upper GI bleeding due to esophagogastric varices, ulcers and other causes; Identified by clinical manifestations, lab tests and endoscopy and measured by number/proportion of patients
Death
Time frame: One Year
Deaths caused by variceal bleeding, hepatocellular carcinoma, liver failure, etc
2 secondary outcomes
New or worsening acute decompensation event other than upper GI bleeding
Time frame: One Year
Liver transplantation/ Transfer to other non-endoscopic therapies
Time frame: One Year
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 6 Dec 2023.
- 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.
Bin Wu, Ph.D principal investigator
Department of Gastroenterology, Third Affiliated Hospital of Sun Yar-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Third Affiliated Hospital, Sun Yat-Sen University 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 6 Dec 2023. 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?
Upper Gastrointestinal Bleeding (time frame: One Year). The study lists 2 primary outcomes in all. 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 6 Dec 2023.