Underdilated-stent Technique Improves Post-TIPS Encephalopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 6mm balloon dilation, 8mm balloon dilation.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis, Variceal Bleeding, Cirrhosis, Ascites Hepatic, Hepatic Encephalopathy (HE). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Underdilated-stent Technique Improves Post-transjugular Intrahepatic Portosystemic Shunt Encephalopathy: a Randomized Controlled Trial
Overview
Transjugular intrahepatic portosystemic shunt (TIPS) is a critical therapeutic approach for managing esophagogastric variceal bleeding and refractory ascites in decompensated cirrhosis patients. To date, hepatic encephalopathy (HE) remains one of the most common complications following TIPS procedures, and prediction and prevention of post-TIPS HE have always been a hotspot in the field of hepatology. However, no reliable clinical studies have confirmed that any drug or intervention can effectively prevent the occurrence of HE episodes following TIPS, including lactulose and rifaximin. Underdilated strategy (UDS) was reported as an development technique proposed in recent years for TIPS procedures, which involves using a small-diameter balloon to dilate the puncture tract and subsequently implanted standard-diameter covered stent (e.g., 8 mm). This allows the stent to maintain a smaller diameter shortly after release, thereby reducing the incidence of hepatic encephalopathy during the postoperative period. Over time, the stent gradually dilates to its normal diameter within months. This period coincides with the higher incidence risk of post-TIPS HE, most commonly occurring within 6 months, especially within the first 3 months after TIPS. Therefore, theoretically, UDS can reduce the occurrence of post-TIPS HE. In terms of clinical research, however, there were still no high quality studies reported the advantages of this technique. Current reported clinical studies were all non-randomized controlled trials or retrospective studies, with low-quality evidence and sometimes contradictory findings. The aim of this prospective randomized controlled clinical study is to evaluate whether administration of underdilated technology during TIPS can improve postoperative hepatic encephalopathy, without compromising the therapeutic efficacy of portal hypertension complications.
Interventions
- Device 6mm balloon dilation
A 6mm balloon was used to under-dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure. - Device 8mm balloon dilation
A standard 8mm balloon was used to fully dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure.
Primary outcome measures
- incidence of overt hepatic encephalopathy [Time frame: 12 months]
Secondary outcome measures (3)
- remission of complications of portal hypertention [Time frame: 12 months]
- liver function [Time frame: 12 months]
- liver transplantation-free survival [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Liver cirrhosis, defined by clinical manifestations, biochemical indicators, imaging examinations, or liver biopsy;
- History of esophagogastric variceal bleeding, or refractory/recurrent ascites;
- Intended to undergo TIPS treatment.
Exclusion criteria
- Non-cirrhotic portal hypertension;
- Previous treatments that may affect portal pressure, such as TIPS or surgical procedures;
- History of overt hepatic encephalopathy (West-Haven classification ≥2);
- Malignant tumors in advanced stages;
- Concomitant irreversible heart, liver, kidney, or respiratory failure;
- Unable or unwilling to sign the informed consent form.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 2 centers
- The Second Affiliated Hospital of Chongqing Medical University — Chongqing
- Qianjiang Central Hospital — Qianjiang
Publications
- Yao W, Liu JC, Wu YJ, Yang CT, Ju SG, Wang YL, Wang CY, Huang SJ, Bai YW, Chen Y, Li TQ, Zhou C, Xiong B. Effect of underdilated transjugular intrahepatic portosystemic shunt on prognosis in patients with prior splenectomy: a propensity score-matched case-control study. Abdom Radiol (NY). 2022 Oct;47(10):3615-3627. doi: 10.1007/s00261-022-03600-7. Epub 2022 Jul 12. PMID 35821274
- Gaba RC, Parvinian A, Minocha J, Casadaban LC, Knuttinen MG, Ray CE Jr, Bui JT. Should transjugular intrahepatic portosystemic shunt stent grafts be underdilated? J Vasc Interv Radiol. 2015 Mar;26(3):382-7. doi: 10.1016/j.jvir.2014.08.012. PMID 25735521
- Trebicka J, Bastgen D, Byrtus J, Praktiknjo M, Terstiegen S, Meyer C, Thomas D, Fimmers R, Treitl M, Euringer W, Sauerbruch T, Rossle M. Smaller-Diameter Covered Transjugular Intrahepatic Portosystemic Shunt Stents Are Associated With Increased Survival. Clin Gastroenterol Hepatol. 2019 Dec;17(13):2793-2799.e1. doi: 10.1016/j.cgh.2019.03.042. Epub 2019 Mar 30. PMID 30940552
- Luo X, Wang X, Zhu Y, Xi X, Zhao Y, Yang J, Li X, Yang L. Clinical Efficacy of Transjugular Intrahepatic Portosystemic Shunt Created with Expanded Polytetrafluoroethylene-Covered Stent-Grafts: 8-mm Versus 10-mm. Cardiovasc Intervent Radiol. 2019 May;42(5):737-743. doi: 10.1007/s00270-019-02162-4. Epub 2019 Jan 14. PMID 30643936
- Lv Y, Chen H, Luo B, Bai W, Li K, Wang Z, Xia D, Guo W, Wang Q, Li X, Yuan J, Cai H, Xia J, Yin Z, Fan D, Han G. Concurrent large spontaneous portosystemic shunt embolization for the prevention of overt hepatic encephalopathy after TIPS: A randomized controlled trial. Hepatology. 2022 Sep;76(3):676-688. doi: 10.1002/hep.32453. Epub 2022 Apr 15. PMID 35266571
- Yang M, Qiu Y, Wang W. Concurrent spontaneous portosystemic shunt embolization for the prevention of overt hepatic encephalopathy after TIPS: A systematic review and meta-analysis. Dig Liver Dis. 2024 Jun;56(6):978-985. doi: 10.1016/j.dld.2023.10.013. Epub 2023 Nov 3. PMID 37926635
- Bureau C, Thabut D, Jezequel C, Archambeaud I, D'Alteroche L, Dharancy S, Borentain P, Oberti F, Plessier A, De Ledinghen V, Ganne-Carrie N, Carbonell N, Rousseau V, Sommet A, Peron JM, Vinel JP. The Use of Rifaximin in the Prevention of Overt Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt : A Randomized Controlled Trial. Ann Intern Med. 2021 May;174(5):633-640. doi: 10 PMID 33524293
- Vilstrup H, Amodio P, Bajaj J, Cordoba J, Ferenci P, Mullen KD, Weissenborn K, Wong P. Hepatic encephalopathy in chronic liver disease: 2014 Practice Guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014 Aug;60(2):715-35. doi: 10.1002/hep.27210. Epub 2014 Jul 8. No abstract available. PMID 25042402
Identifiers
NCT: NCT07349654 · UDS-TIPS-01