Liver CirrhosisNCT07349654
Underdilated-stent Technique Improves Post-TIPS Encephalopathy
A study testing 6mm balloon dilation and 8mm balloon dilation in people with Liver Cirrhosis and Variceal Bleeding, Cirrhosis, run by The Second Affiliated Hospital of Chongqing Medical University at 2 sites in China.
Trial summary
Transjugular intrahepatic portosystemic shunt (TIPS) is a critical therapeutic approach for managing esophagogastric variceal bleeding and refractory ascites in decompensated cirrhosis patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Variceal Bleeding, Cirrhosis, Ascites Hepatic
- What is being tested?
- 6mm balloon dilation and 8mm balloon dilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesChina
- Study dates
- 19 Nov 2024to 31 Dec 2027
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400072
Song He, Doctor, +86 13281121937, hedoctor65@cqmu.edu.cn
Yongjun Zhu
- Recruiting
Qianjiang Central Hospital
Qianjiang, Chongqing Municipality, 409099
Fei Xiang, 86-23-79246331, xinagfei123@126.com
Fei Xiang
About this study
Official title: Underdilated-stent Technique Improves Post-transjugular Intrahepatic Portosystemic Shunt Encephalopathy: a Randomized Controlled Trial
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
- Liver Cirrhosis, Variceal Bleeding, Cirrhosis, Ascites Hepatic, Hepatic Encephalopathy (HE)
- Being tested
- 6mm balloon dilation, 8mm balloon dilation
- Medical subject headings
- Liver Cirrhosis, Fibrosis, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6mm balloon dilationDevice
A 6mm balloon was used to under-dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure.
8mm balloon dilationDevice
A standard 8mm balloon was used to fully dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: 8mm balloon dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of overt hepatic encephalopathy
West-Haven grade no less than 2.
Measured: 12 months
Secondary outcomes (3)
remission of complications of portal hypertention
variceal rebleeding diagnosed on endoscopy, or worsened ascites diagnosed by ultrasound or CT/MRI.
Measured: 12 months
liver function
Child-Pugh Classification
Measured: 12 months
liver transplantation-free survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start19 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Qianjiang Hospital, Chongqing University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349654
- Sponsor's protocol ID
- UDS-TIPS-01
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35821274Gaba 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.
PubMed 25735521Trebicka 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.
PubMed 30940552Luo 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.
PubMed 30643936Lv 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.
PubMed 35266571Yang 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.
PubMed 37926635Bureau 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.
PubMed 33524293Vilstrup 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.
PubMed 25042402Riggio 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.
PubMed 22321469Riggio 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.
PubMed 20036625Yang 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.
PubMed 35667296Kabelitz 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.
PubMed 40097036Riggio 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.
PubMed 18775022Bureau 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.
PubMed 14762784Perarnau 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.
PubMed 24480619
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Underdilated-stent Technique Improves Post-transjugular Intrahepatic Portosystemic Shunt Encephalopathy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07349654
- Acronym / sponsor ID
- UDS-TIPS-01
- Conditions
- Liver Cirrhosis, Variceal Bleeding, Cirrhosis, Ascites Hepatic, Hepatic Encephalopathy (HE)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- West China Hospital, Qianjiang Hospital, Chongqing University
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jan 2026 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| underdilation group | Experimental | Device: 6mm balloon dilationPatients 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. |
| full-dilation group | Active comparator | Device: 8mm balloon dilationPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| 6mm balloon dilationA 6mm balloon was used to under-dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure. | Device | underdilation group |
| 8mm balloon dilationA standard 8mm balloon was used to fully dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure. | Device | full-dilation group |
Primary outcome
incidence of overt hepatic encephalopathy
Time frame: 12 months
West-Haven grade no less than 2.
3 secondary outcomes
remission of complications of portal hypertention
Time frame: 12 months
liver function
Time frame: 12 months
liver transplantation-free survival
Time frame: 12 months
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 20 Jan 2026.
- Results publication: PubMed 35821274Yao 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.
- Results publication: PubMed 25735521Gaba 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.
- Results publication: PubMed 30940552Trebicka 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.
- Results publication: PubMed 30643936Luo 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.
- Results publication: PubMed 35266571Lv 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.
- Results publication: PubMed 37926635Yang 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.
- Results publication: PubMed 33524293Bureau 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.
- Results publication: PubMed 25042402Vilstrup 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.
- Results publication: PubMed 22321469Riggio 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.
- Results publication: PubMed 20036625Riggio 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.
- Results publication: PubMed 35667296Yang 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.
- Results publication: PubMed 40097036Kabelitz 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.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6mm balloon dilation and 8mm balloon dilation in people with Liver Cirrhosis and Variceal Bleeding, Cirrhosis, run by The Second Affiliated Hospital of Chongqing Medical University at 2 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 3 inclusion and 6 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 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Yongjun Zhu, Doctor (86-13281121937, hp545204493@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of overt hepatic encephalopathy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07349654, which also lists 18 linked publications.
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 20 Jan 2026.