CirrhosisNCT07172035
The Impact of Transjugular Intrahepatic Portosystemic Shunt on Recompensation in Patients With Decompensated Liver Cirrhosis
An observational study of Cirrhosis and Decompensation, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 15 sites in China.
Trial summary
The traditional view holds that the natural course of cirrhosis is a unidirectional process, characterized by irreversible progression from the compensated stage to the decompensated stage, and is highly likely to develop further decompensation events or even death. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhosis, Decompensation, Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- How many people
- 250 participants
- Where
- 15 sitesChina
- Study dates
- 1 Aug 2025to 1 Aug 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population of this research consists of patients with decompensated cirrhotic portal hypertension who meet the predefined inclusion and exclusion criteria and undergo transjugular intrahepatic portosystemic shunt (TIPS) treatment.
Who may be able to join
- Age between 18 and 80 years old;
- Diagnosed with decompensated liver cirrhosis (diagnostic criteria: positive liver histopathological examination, or comprehensive judgment based on clinical symptoms, biochemical indicators and imaging features);
- The etiology of liver cirrhosis is intervenable (including hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, alcoholic liver disease (ALD), etc.);
- Patients with indications for Transjugular Intrahepatic Portosystemic Shunt (TIPS) treatment of cirrhotic portal hypertension, such as those with cirrhotic portal hypertension-related esophagogastric variceal bleeding refractory to endoscopic treatment, and patients with refractory ascites caused by cirrhotic portal hypertension;
- Obtained informed consent signed by the patient or their family members.
Who cannot join
- Compensated liver cirrhosis at the time of TIPS treatment (without decompensated events such as ascites, hepatic encephalopathy, or esophagogastric variceal bleeding);
- TIPS performed for the treatment of non-cirrhotic portal hypertension (e.g., idiopathic portal hypertension, Budd-Chiari syndrome, sinusoidal obstruction syndrome, etc.);
- Patients complicated with malignant tumors such as hepatocellular carcinoma (HCC), renal cell carcinoma, or lung cancer prior to TIPS;
- Patients with severe cardiopulmonary dysfunction or a Model for End-Stage Liver Disease (MELD) score > 18;
- Pregnant patients;
- Patients with uncontrolled systemic infection or inflammation;
Show all 11Show fewer
- Patients with severe coagulation disorders;
- Patients allergic to contrast medium.
- Criteria for Termination/Withdrawal from the Study:
- Patients with Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure failure due to various reasons;
- Patients who voluntarily request to withdraw from the study.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Second Xiangya Hospital, Central South University
Changsha
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha
- Recruiting
Fujian Medical University Union Hospital
Fuzhou
- Recruiting
Huanggang Central Hospital
Huanggang
- Recruiting
Jingzhou Central Hospital
Jingzhou
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing
- Recruiting
Shengjing Hospital of China Medical University
Shenyang
- Recruiting
Shanxi Provincial People's Hospital
Taiyuan
- Recruiting
Renmin Hospital of Wuhan University
Wuhan
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan
- Recruiting
Xiangyang Central Hospital
Xiangyang
- Recruiting
Yichang Central People's Hospital
Yichang
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Recompensation in Patients With Decompensated Cirrhosis: A Multicenter Prospective Cohort Study
The traditional view holds that the natural course of cirrhosis is a unidirectional process, characterized by irreversible progression from the compensated stage to the decompensated stage, and is highly likely to develop further decompensation events or even death. However, a growing body of evidence suggests that the natural course of cirrhosis is not always unidirectional - after the removal of the etiology, the structural and functional changes of the liver may be partially reversed. This understanding has given rise to the concept of "liver recompensation," which has been standardized at the Baveno VII Consensus Conference. Notably, in a cohort of patients with alcohol-related cirrhosis, 18% achieved recompensation, which was significantly associated with a reduction of more than 90% in liver-related mortality. In patients with hepatitis B-related cirrhosis, 6% achieved recompensation after treatment with nucleos(t)ide analogs, with a similar improvement in mortality.
Transjugular intrahepatic portosystemic shunt (TIPS) is a well-established therapy for complications related to portal hypertension, including gastroesophageal variceal bleeding, refractory ascites, and hepatic hydrothorax. Compared with standard treatment, TIPS has been proven to reduce the incidence of further decompensation and improve transplant-free survival. However, due to portal blood shunting, the risks of abnormal liver function and hepatic encephalopathy (HE) also increase. It is worth noting that TIPS is not included in the definition of recompensation in the Baveno VII Consensus. Therefore, whether patients with cirrhosis who undergo TIPS treatment can achieve recompensation and which factors determine the probability of recompensation remain unknown. More importantly, the impact of recompensation on the risk of HCC development and mortality in TIPS patients has not been studied prospectively.
- Conditions
- Cirrhosis, Decompensation, Transjugular Intrahepatic Portosystemic Shunt (TIPS), Survival Analysis
- Keywords
- Cirrhosis, decompensation, transjugular intrahepatic portosystemic shunt (TIPS), Survival analysis
- Medical subject headings
- Fibrosis
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 |
|---|---|---|
| Recompensation group | Refers to the group of patients who simultaneously meet the three core criteria of "etiology cure", "resolution of decompensation events" and "sustained improvement of liver function" at 1 year after TIPS creation | |
| Non-Recompensation Group | Refers to the group of patients who fail to meet the three core criteria of "etiology cure", "resolution of decompensation events" and "sustained improvement of liver function" at 1 year after TIPS creation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year post-TIPS recompensation rate
It refers to the proportion of patients who meet the standardized recompensation criteria (etiology cure, resolution of decompensation events and sustained improvement of liver function) at 12 months after TIPS.
Measured: 1 year
Secondary outcomes (3)
Identification of factors associated with recompensation at 1 year after TIPS
It refers to the screening and confirmation of potential factors that may affect whether patients achieve recompensation at 1 year after TIPS. Cox Univariate analysis and multivariate regression analysis will be used to identify independent factors associated with recompensation, providing a basis for individualized intervention strategies to improve the recompensation rate of TIPS patients.
Measured: 1 year
Impact of recompensation on the risk of hepatocellular carcinoma (HCC) development
It refers to the comparison of the incidence of HCC between the recompensation group and the non-recompensation group during the follow-up period after TIPS surgery.
Measured: 1 year
Impact of recompensation after Transjugular Intrahepatic Portosystemic Shunt on patients' risk of death
At 12 months after Transjugular Intrahepatic Portosystemic Shunt (TIPS), patients were divided into the recompensation group and the non-recompensation group based on whether they met the recompensation criteria, and the Log-rank test was used to analyze the differences in survival outcomes between the two groups.
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 posted15 Sep 2025
- Study start1 Aug 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongnan Hospital, Yichang Central People's Hospital, Jingzhou Central Hospital, Xiangyang Central Hospital, Jiangxi Provincial People's Hopital, The Central Hospital of Huanggang, Second Xiangya Hospital of Central South University, Shengjing Hospital, The First Affiliated Hospital with Nanjing Medical University, Shanxi Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, The Third Xiangya Hospital of Central South University, Fujian Medical University Union Hospital, Renmin Hospital of Wuhan University
- Responsible party
- Principal investigator, Yaowei Bai, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172035
- Sponsor's protocol ID
- TIPS-Recompensation
- Status last verified
- Nov 2025
- First submitted
- 5 Sep 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Recompensation in Patients With Decompensated Cirrhosis: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07172035
- Acronym / sponsor ID
- TIPS-Recompensation
- Conditions
- Cirrhosis, Decompensation, Transjugular Intrahepatic Portosystemic Shunt (TIPS), Survival Analysis
- Keywords
- Cirrhosis, decompensation, transjugular intrahepatic portosystemic shunt (TIPS), Survival analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Zhongnan Hospital, Yichang Central People's Hospital, Jingzhou Central Hospital, Xiangyang Central Hospital, Jiangxi Provincial People's Hopital, The Central Hospital of Huanggang, Second Xiangya Hospital of Central South University, Shengjing Hospital, The First Affiliated Hospital with Nanjing Medical University, Shanxi Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, The Third Xiangya Hospital of Central South University, Fujian Medical University Union Hospital, Renmin Hospital of Wuhan University
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 15 Sep 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.
The traditional view holds that the natural course of cirrhosis is a unidirectional process, characterized by irreversible progression from the compensated stage to the decompensated stage, and is highly likely to develop further decompensation events or even death. However, a growing body of evidence suggests that the natural course of cirrhosis is not always unidirectional - after the removal of the etiology, the structural and functional changes of the liver may be partially reversed. This understanding has given rise to the concept of "liver recompensation," which has been standardized at the Baveno VII Consensus Conference. Notably, in a cohort of patients with alcohol-related cirrhosis, 18% achieved recompensation, which was significantly associated with a reduction of more than 90% in liver-related mortality. In patients with hepatitis B-related cirrhosis, 6% achieved recompensation after treatment with nucleos(t)ide analogs, with a similar improvement in mortality.
Transjugular intrahepatic portosystemic shunt (TIPS) is a well-established therapy for complications related to portal hypertension, including gastroesophageal variceal bleeding, refractory ascites, and hepatic hydrothorax. Compared with standard treatment, TIPS has been proven to reduce the incidence of further decompensation and improve transplant-free survival. However, due to portal blood shunting, the risks of abnormal liver function and hepatic encephalopathy (HE) also increase. It is worth noting that TIPS is not included in the definition of recompensation in the Baveno VII Consensus. Therefore, whether patients with cirrhosis who undergo TIPS treatment can achieve recompensation and which factors determine the probability of recompensation remain unknown. More importantly, the impact of recompensation on the risk of HCC development and mortality in TIPS patients has not been studied prospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recompensation group | – | –Refers to the group of patients who simultaneously meet the three core criteria of "etiology cure", "resolution of decompensation events" and "sustained improvement of liver function" at 1 year after TIPS creation |
| Non-Recompensation Group | – | –Refers to the group of patients who fail to meet the three core criteria of "etiology cure", "resolution of decompensation events" and "sustained improvement of liver function" at 1 year after TIPS creation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population of this research consists of patients with decompensated cirrhotic portal hypertension who meet the predefined inclusion and exclusion criteria and undergo transjugular intrahepatic portosystemic shunt (TIPS) treatment.
Key inclusion criteria (5 listed)
- Age between 18 and 80 years old;
- Diagnosed with decompensated liver cirrhosis (diagnostic criteria: positive liver histopathological examination, or comprehensive judgment based on clinical symptoms, biochemical indicators and imaging features);
- The etiology of liver cirrhosis is intervenable (including hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, alcoholic liver disease (ALD), etc.);
- Patients with indications for Transjugular Intrahepatic Portosystemic Shunt (TIPS) treatment of cirrhotic portal hypertension, such as those with cirrhotic portal hypertension-related esophagogastric variceal bleeding refractory to endoscopic treatment, and patients with refractory ascites caused by cirrhotic portal hypertension;
- Obtained informed consent signed by the patient or their family members.
Key exclusion criteria (11 listed)
- Compensated liver cirrhosis at the time of TIPS treatment (without decompensated events such as ascites, hepatic encephalopathy, or esophagogastric variceal bleeding);
- TIPS performed for the treatment of non-cirrhotic portal hypertension (e.g., idiopathic portal hypertension, Budd-Chiari syndrome, sinusoidal obstruction syndrome, etc.);
- Patients complicated with malignant tumors such as hepatocellular carcinoma (HCC), renal cell carcinoma, or lung cancer prior to TIPS;
- Patients with severe cardiopulmonary dysfunction or a Model for End-Stage Liver Disease (MELD) score > 18;
- Pregnant patients;
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
1-year post-TIPS recompensation rate
Time frame: 1 year
It refers to the proportion of patients who meet the standardized recompensation criteria (etiology cure, resolution of decompensation events and sustained improvement of liver function) at 12 months after TIPS.
3 secondary outcomes
Identification of factors associated with recompensation at 1 year after TIPS
Time frame: 1 year
Impact of recompensation on the risk of hepatocellular carcinoma (HCC) development
Time frame: 1 year
Impact of recompensation after Transjugular Intrahepatic Portosystemic Shunt on patients' risk of death
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 5 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Decompensation, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 15 sites 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
Contact Yaowei Bai (+8618627162379, baiyaowei918@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year post-TIPS recompensation rate (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 5 Dec 2025.