Underdilated-stent Technique Improves Post-TIPS Encephalopathy

NCT07349654 | Recruiting

• 1 other identifier: UDS-TIPS-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Ascites Hepatic; Hepatic Encephalopathy (HE); Liver Cirrhosis; Variceal Bleeding, Cirrhosis

Outcome Measures

Primary Outcomes (1)

• incidence of overt hepatic encephalopathy

  West-Haven grade no less than 2.

  12 months

Secondary Outcomes (3)

• remission of complications of portal hypertention

  12 months

• liver function

  12 months

• liver transplantation-free survival

  12 months

Study Arms (2)

underdilation group

EXPERIMENTAL

Patients in this group will receive a underdilated strategy during TIPS procedure by using a 6mm balloon to dilate the puncture tract and subsequently implanted 8mm Viatorr stent.

Device: 6mm balloon dilation

full-dilation group

ACTIVE COMPARATOR

Patients in this group will receive a fully-dilated strategy during TIPS procedure by using a 8mm balloon to dilate the puncture tract and subsequently implanted 8mm Viatorr stent.

Device: 8mm balloon dilation

Interventions

6mm balloon dilation DEVICE

A 6mm balloon was used to under-dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure.

underdilation group

8mm balloon dilation DEVICE

A standard 8mm balloon was used to fully dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure.

full-dilation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead
• West China Hospital: collaborator
• Qianjiang Hospital, Chongqing University: collaborator

Study Sites (2)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400072, China

RECRUITING

Qianjiang Central Hospital

Qianjiang, Chongqing Municipality, 409099, China

RECRUITING

Related Publications (18)

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  PMID: 35821274 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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: 10.7326/M20-0202. Epub 2021 Feb 2.

  PMID: 33524293 RESULT

• 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 RESULT

• Riggio O, Nardelli S, Moscucci F, Pasquale C, Ridola L, Merli M. Hepatic encephalopathy after transjugular intrahepatic portosystemic shunt. Clin Liver Dis. 2012 Feb;16(1):133-46. doi: 10.1016/j.cld.2011.12.008. Epub 2012 Jan 4.

  PMID: 22321469 RESULT

• Riggio O, Ridola L, Lucidi C, Angeloni S. Emerging issues in the use of transjugular intrahepatic portosystemic shunt (TIPS) for management of portal hypertension: time to update the guidelines? Dig Liver Dis. 2010 Jul;42(7):462-7. doi: 10.1016/j.dld.2009.11.007. Epub 2009 Dec 29.

  PMID: 20036625 RESULT

• Yang Y, Liang X, Yang S, He X, Huang M, Shi W, Luo J, Duan C, Feng X, Fu S, Lu L. Preoperative prediction of overt hepatic encephalopathy caused by transjugular intrahepatic portosystemic shunt. Eur J Radiol. 2022 Sep;154:110384. doi: 10.1016/j.ejrad.2022.110384. Epub 2022 May 28.

  PMID: 35667296 RESULT

• Kabelitz MA, Sandmann L, Praktiknjo M, Mauz JB, Auer TA, Bruns T, Chang J, Engelmann C, Fehrenbach U, Hinrichs J, Jansen C, Kloeckner R, Kluwe J, Kohler M, Meyer C, Piecha F, Pollmanns MR, Ripoll C, Schultheiss M, Seifert LL, Stohr F, Sturm L, Trebicka J, Zipprich A, Labenz C, Bettinger D, Maasoumy B; German Cirrhosis Study Group. Early Occurrence of Hepatic Encephalopathy Following Transjugular Intrahepatic Portosystemic Shunt Insertion is Linked to Impaired Survival: A Multicenter Cohort Study. Clin Gastroenterol Hepatol. 2025 Nov;23(12):2214-2223.e27. doi: 10.1016/j.cgh.2025.01.024. Epub 2025 Mar 15.

  PMID: 40097036 RESULT

• Riggio O, Angeloni S, Salvatori FM, De Santis A, Cerini F, Farcomeni A, Attili AF, Merli M. Incidence, natural history, and risk factors of hepatic encephalopathy after transjugular intrahepatic portosystemic shunt with polytetrafluoroethylene-covered stent grafts. Am J Gastroenterol. 2008 Nov;103(11):2738-46. doi: 10.1111/j.1572-0241.2008.02102.x. Epub 2008 Sep 4.

  PMID: 18775022 RESULT

• Bureau C, Garcia-Pagan JC, Otal P, Pomier-Layrargues G, Chabbert V, Cortez C, Perreault P, Peron JM, Abraldes JG, Bouchard L, Bilbao JI, Bosch J, Rousseau H, Vinel JP. Improved clinical outcome using polytetrafluoroethylene-coated stents for TIPS: results of a randomized study. Gastroenterology. 2004 Feb;126(2):469-75. doi: 10.1053/j.gastro.2003.11.016.

  PMID: 14762784 RESULT

• Perarnau JM, Le Gouge A, Nicolas C, d'Alteroche L, Borentain P, Saliba F, Minello A, Anty R, Chagneau-Derrode C, Bernard PH, Abergel A, Ollivier-Hourmand I, Gournay J, Ayoub J, Gaborit C, Rusch E, Giraudeau B; STIC-TIPS group. Covered vs. uncovered stents for transjugular intrahepatic portosystemic shunt: a randomized controlled trial. J Hepatol. 2014 May;60(5):962-8. doi: 10.1016/j.jhep.2014.01.015. Epub 2014 Jan 27.

  PMID: 24480619 RESULT

• Gupta AC, Wang W, Shah C, Sands MJ, Bullen J, Remer EM, Bayona PM, Carey W, Kapoor B. Added Value of Covered Stents in Transjugular Intrahepatic Portosystemic Shunt: A Large Single-Center Experience. Cardiovasc Intervent Radiol. 2017 Nov;40(11):1723-1731. doi: 10.1007/s00270-017-1694-1. Epub 2017 May 16.

  PMID: 28512687 RESULT

• Wang Q, Lv Y, Bai M, Wang Z, Liu H, He C, Niu J, Guo W, Luo B, Yin Z, Bai W, Chen H, Wang E, Xia D, Li X, Yuan J, Han N, Cai H, Li T, Xie H, Xia J, Wang J, Zhang H, Wu K, Fan D, Han G. Eight millimetre covered TIPS does not compromise shunt function but reduces hepatic encephalopathy in preventing variceal rebleeding. J Hepatol. 2017 Sep;67(3):508-516. doi: 10.1016/j.jhep.2017.05.006. Epub 2017 May 12.

  PMID: 28506905 RESULT

• Dariushnia SR, Haskal ZJ, Midia M, Martin LG, Walker TG, Kalva SP, Clark TW, Ganguli S, Krishnamurthy V, Saiter CK, Nikolic B; Society of Interventional Radiology Standards of Practice Committee. Quality Improvement Guidelines for Transjugular Intrahepatic Portosystemic Shunts. J Vasc Interv Radiol. 2016 Jan;27(1):1-7. doi: 10.1016/j.jvir.2015.09.018. Epub 2015 Nov 21. No abstract available.

  PMID: 26614596 RESULT

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Yongjun Zhu, Doctor

CONTACT

86-13281121937; hp545204493@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 20, 2026
• Study Start: November 19, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)