Esophageal Varices BleedingNCT06961474
Effectiveness of Treatments for Cirrhosis With Varicose Veins
An observational study of Esophageal Varices Bleeding and Portal Hypertension, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Liver cirrhosis is the fifth leading cause of death among adults, characterized by diffuse fibrous tissue proliferation and the formation of regenerative nodules and false lobules on the basis of widespread hepatocyte necrosis, leading to severe complications such as portal hypertension and liver failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Varices Bleeding, Portal Hypertension
- What is being tested?
- Endoscopic treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,900 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: Patients admitted for portal hypertension-related esophageal and gastric varices from February 2022 to December 2024.
Who may be able to join
- ① Age greater than 18 years, with no gender restriction.
- ② Patients admitted for portal hypertension-related esophageal and gastric varices from February 2022 to December 2024.
Who cannot join
- Age < 18 years ② Absence of esophageal or gastric varices ③ Incomplete medical history records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Treatments for Cirrhosis With Varicose Veins:A Prospective Observational Study
Liver cirrhosis is the fifth leading cause of death among adults, characterized by diffuse fibrous tissue proliferation and the formation of regenerative nodules and false lobules on the basis of widespread hepatocyte necrosis, leading to severe complications such as portal hypertension and liver failure. Cirrhosis is categorized into compensated and decompensated stages based on the presence or absence of clinical events such as ascites, variceal rupture bleeding, and hepatic encephalopathy. Patients with decompensated cirrhosis have a significantly shorter median survival time compared to those in the compensated stage. Esophagogastric variceal hemorrhage is a common life-threatening complication in patients with portal hypertension due to cirrhosis, with high incidence rates and mortality. Current preventive and therapeutic approaches for variceal bleeding include pharmacological therapy, endoscopic treatment, transjugular intrahepatic portosystemic shunt (TIPS), and surgical interventions. However, mortality remains high, and each treatment modality has its own limitations and controversies.
This study aims to prospectively investigate the clinical characteristics of portal hypertension caused by various etiologies (e.g., hepatitis B, autoimmune diseases, schistosomiasis) and to compare the efficacy and safety of endoscopic and interventional treatments for varices, providing evidence-based medical support for clinical diagnosis and treatment. The study includes patients admitted for portal hypertension-related esophagogastric varices from February 2022 to December 2024, excluding those under 18 years of age, without varices, or with incomplete medical records. Baseline data, including demographic features, medical history, laboratory tests, imaging examinations, and Child-Pugh classification, will be collected. Follow-up assessments will be conducted at 1, 2, 6, and 12 months post-treatment to monitor adverse events (e.g., rebleeding, hepatic encephalopathy, ascites) and survival status. The primary endpoint is the rebleeding rate within one year, while secondary endpoints include mortality and the incidence of portal hypertension-related complications.
The sample size is estimated at 1,900 patients, with 1,500 in the endoscopic treatment group and 400 in the non-endoscopic treatment group. Statistical analysis will be performed using SPSS 24.0 and R software, with continuous data analyzed using t-tests or rank-sum tests and categorical data analyzed using chi-square tests or Fisher's exact test. The study has been approved by the ethics committee, and informed consent will be obtained from all participants.
- Conditions
- Esophageal Varices Bleeding, Portal Hypertension
- Being tested
- Endoscopic treatment
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic treatmentProcedure or surgery
The endoscopic treatment methods for patients with esophageal variceal rupture bleeding usually include variceal ligation and injection of tissue adhesive.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic treatment group | Not described Receives: Procedure: Endoscopic treatment | |
| Non-endoscopic treatment group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding within one year
Measured: 1 year
Secondary outcomes (1)
Mortality within 1 year and the occurrence of portal hypertension-related complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Feb 2022
- Primary completion31 Dec 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Varices BleedingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shiyao Chen, Ph.D., Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961474
- Sponsor's protocol ID
- B2022-109
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Treatments for Cirrhosis With Varicose Veins:A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06961474
- Acronym / sponsor ID
- B2022-109
- Conditions
- Esophageal Varices Bleeding, Portal Hypertension
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 May 2025 (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.
Liver cirrhosis is the fifth leading cause of death among adults, characterized by diffuse fibrous tissue proliferation and the formation of regenerative nodules and false lobules on the basis of widespread hepatocyte necrosis, leading to severe complications such as portal hypertension and liver failure. Cirrhosis is categorized into compensated and decompensated stages based on the presence or absence of clinical events such as ascites, variceal rupture bleeding, and hepatic encephalopathy. Patients with decompensated cirrhosis have a significantly shorter median survival time compared to those in the compensated stage. Esophagogastric variceal hemorrhage is a common life-threatening complication in patients with portal hypertension due to cirrhosis, with high incidence rates and mortality. Current preventive and therapeutic approaches for variceal bleeding include pharmacological therapy, endoscopic treatment, transjugular intrahepatic portosystemic shunt (TIPS), and surgical interventions. However, mortality remains high, and each treatment modality has its own limitations and controversies.
This study aims to prospectively investigate the clinical characteristics of portal hypertension caused by various etiologies (e.g., hepatitis B, autoimmune diseases, schistosomiasis) and to compare the efficacy and safety of endoscopic and interventional treatments for varices, providing evidence-based medical support for clinical diagnosis and treatment. The study includes patients admitted for portal hypertension-related esophagogastric varices from February 2022 to December 2024, excluding those under 18 years of age, without varices, or with incomplete medical records. Baseline data, including demographic features, medical history, laboratory tests, imaging examinations, and Child-Pugh classification, will be collected. Follow-up assessments will be conducted at 1, 2, 6, and 12 months post-treatment to monitor adverse events (e.g., rebleeding, hepatic encephalopathy, ascites) and survival status. The primary endpoint is the rebleeding rate within one year, while secondary endpoints include mortality and the incidence of portal hypertension-related complications.
The sample size is estimated at 1,900 patients, with 1,500 in the endoscopic treatment group and 400 in the non-endoscopic treatment group. Statistical analysis will be performed using SPSS 24.0 and R software, with continuous data analyzed using t-tests or rank-sum tests and categorical data analyzed using chi-square tests or Fisher's exact test. The study has been approved by the ethics committee, and informed consent will be obtained from all participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic treatment group | – | Procedure: Endoscopic treatment |
| Non-endoscopic treatment group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for portal hypertension-related esophageal and gastric varices from February 2022 to December 2024.
Key inclusion criteria (2 listed)
- ① Age greater than 18 years, with no gender restriction.
- ② Patients admitted for portal hypertension-related esophageal and gastric varices from February 2022 to December 2024.
Key exclusion criteria (1 listed)
- Age < 18 years ② Absence of esophageal or gastric varices ③ Incomplete medical history records
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 |
|---|---|---|
| Endoscopic treatmentThe endoscopic treatment methods for patients with esophageal variceal rupture bleeding usually include variceal ligation and injection of tissue adhesive. | Procedure or surgery | Endoscopic treatment group |
Primary outcome
Rebleeding within one year
Time frame: 1 year
1 secondary outcome
Mortality within 1 year and the occurrence of portal hypertension-related complications
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
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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, Ph.D. 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?
An observational study of Esophageal Varices Bleeding and Portal Hypertension, 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 1 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 within one year (time frame: 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 8 May 2025.