An observational study in Portal Hypertension Related to Cirrhosis, Ascites and Esophageal Variceal Bleeding, sponsored by The Second Affiliated Hospital of Chongqing Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by The Second Affiliated Hospital of Chongqing Medical University · Observational
This multicenter, prospective observational study aims to learn whether a prediction model using routine clinical data, imaging findings (including spleen stiffness measurement), and circulating biomarkers can predict stent dysfunction and longer-term outcomes after transjugular intrahepatic portosystemic shunt (TIPS) in adults with portal hypertension. The main question it aims to answer is:
Does this model predict TIPS stent dysfunction within 1 year after the procedure, and does it perform better than Doppler ultrasound for assessing stent function? Secondary questions include whether the model can predict further decompensation, liver failure, recompensation, and liver-related death over 3 years, and whether periodontal status and circulating biomarkers are associated with adverse outcomes after TIPS.
About 1,490 participants aged 18-80 years who are scheduled to undergo TIPS as part of their routine medical care will be enrolled at multiple centers and followed for up to 3 years. This is an observational study; participants receive usual medical care, and no treatment is assigned by the study. No additional study-specific visits are required. Data will be collected from routine clinical records at baseline, during TIPS, within 1 week after TIPS, and at follow-up visits (1, 3, and 6 months, then every 6 months). Optional blood, stool, urine, gingival crevicular fluid, and subgingival plaque samples may be collected for biomarker and mechanism research. The primary endpoint is TIPS stent dysfunction within 1 year after the procedure.
247 studies on the registry are indexed under Ascites; 57 are open to participants now.
This study's planned enrollment of 1,490 is above the median of 100 across 54 observational studies indexed under Ascites.
Browse Ascites studies →The Second Affiliated Hospital of Chongqing Medical University is the lead sponsor of 102 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of adults aged 18-80 years with portal hypertension who are scheduled to undergo transjugular intrahepatic portosystemic shunt (TIPS) as part of routine clinical care at multiple participating centers. Approximately 1,490 participants will be enrolled in this multicenter, prospective observational cohort. Patients with intrahepatic or extrahepatic malignancy (including solid and hematologic tumors), other diseases with expected survival \<6 months, failed TIPS, pregnancy or breastfeeding, or those judged unsuitable by the investigator will be excluded. Participants receive usual medical care without study-assigned treatment and are followed for up to 3 years through routine clinical visits (1, 3, and 6 months after TIPS, then every 6 months) to capture stent dysfunction, further decompensation, recompensation, liver failure, and liver disease-related death.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIPS stent dysfunction within 1 year after TIPS
Incidence of TIPS stent dysfunction, defined as either: (1) no clinical response or recurrence of portal hypertension complications (ascites not relieved or new/worsening ascites; variceal rebleeding; new or unexplained hepatic hydrothorax); or (2) Doppler ultrasound evidence of TIPS stent dysfunction (e.g., significantly abnormal intra-stent flow velocity, decreased main portal vein velocity, or hepatofugal flow in intrahepatic portal branches). Either condition must be confirmed by subsequent angiography showing stent or outflow tract stenosis ≥50% or complete occlusion, or by a portal pressure gradient (PPG) \>12 mmHg or a ≤50% reduction from the preprocedural baseline PPG.
Time frame: Within 1 year after the TIPS procedure (from the index TIPS procedure through 12 months).
Further decompensation within 3 years after TIPS
Incidence of further decompensation, defined per Baveno VII as any of the following: (1) a second portal hypertension-related decompensating event (ascites, variceal bleeding, or hepatic encephalopathy); (2) recurrent variceal bleeding, recurrent ascites (requiring ≥3 large-volume paracenteses within 1 year), recurrent encephalopathy, spontaneous bacterial peritonitis, and/or hepatorenal syndrome-related acute kidney injury; or (3) new-onset ascites or encephalopathy after TIPS in patients whose only pre-TIPS decompensation was variceal bleeding
Time frame: Within 3 years after the TIPS procedure.
Recompensation within 3 years after TIPS
Incidence of recompensation, defined per Baveno VII as sustained resolution of ascites, hepatic encephalopathy, and variceal bleeding for at least 12 months after removal/control of the underlying etiology, together with stable improvement in liver function.
Time frame: Within 3 years after the TIPS procedure.
Liver failure within 1 year after TIPS
Incidence of liver failure, defined per the EASL Clinical Practice Guidelines on acute-on-chronic liver failure (2023) as total bilirubin ≥12 mg/dL plus any of the following: (1) INR ≥2.5; (2) serum creatinine ≥2.0 mg/dL or need for renal replacement therapy; (3) hepatic encephalopathy grade ≥3 (West Haven); (4) need for vasopressors to maintain blood pressure; or (5) PaO2/FiO2 ≤200 or SpO2/FiO2 ≤214.
Time frame: Within 1 year after the TIPS procedure.
Liver failure within 3 years after TIPS
Incidence of liver failure, defined per the EASL Clinical Practice Guidelines on acute-on-chronic liver failure (2023) as total bilirubin ≥12 mg/dL plus any of the following: (1) INR ≥2.5; (2) serum creatinine ≥2.0 mg/dL or need for renal replacement therapy; (3) hepatic encephalopathy grade ≥3 (West Haven); (4) need for vasopressors to maintain blood pressure; or (5) PaO2/FiO2 ≤200 or SpO2/FiO2 ≤214.
Time frame: Within 3 years after the TIPS procedure.
Liver disease-related death within 3 years after TIPS
Incidence of death directly attributable to liver disease, including death from liver failure, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, or other liver-related causes, as recorded during routine follow-up.
Time frame: Within 3 years after the TIPS procedure.
No study locations are listed for this record.
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
Of 28 observational studies under Ascites, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 20. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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