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Underdilated VCX-TIPS Versus EVL Plus NSBB for Secondary Prophylaxis of Variceal Bleeding in Cirrhosis (U-TIPS)

7 maggio 2026 aggiornato da: Xiaoze Wang, West China Hospital

Underdilated VIATORR Controlled Expansion Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Nonselective Beta-Blockers for Secondary Prophylaxis of Variceal Bleeding in Patients With Cirrhosis: A Multicenter, Open-Label, Randomized Controlled Trial

Variceal bleeding is a major complication of portal hypertension in patients with cirrhosis and is associated with substantial risks of rebleeding and death. Current guidelines recommend endoscopic variceal ligation combined with nonselective beta-blockers as standard secondary prophylaxis for esophageal variceal bleeding and type 1 gastroesophageal variceal bleeding. Transjugular intrahepatic portosystemic shunt can markedly reduce portal pressure and prevent recurrent variceal bleeding, but its broader use in secondary prophylaxis is limited by the risk of post-TIPS hepatic encephalopathy and liver function deterioration.

The VIATORR Controlled Expansion stent is designed to allow controlled expansion between 8 and 10 mm. However, even 8-mm TIPS may still be associated with a substantial risk of overt hepatic encephalopathy. This trial evaluates an underdilated VCX-TIPS strategy, in which a commercially available 8-10 mm VIATORR Controlled Expansion stent is initially dilated only with a 6-mm balloon, aiming to achieve sufficient portal decompression while reducing the risk of excessive shunting.

This is a prospective, multicenter, open-label, parallel-group, randomized superiority trial. Eligible patients with cirrhosis who have recovered from acute esophageal variceal bleeding or type 1 gastroesophageal variceal bleeding and have entered the secondary prophylaxis phase will be randomly assigned in a 1:1 ratio to receive either underdilated VCX-TIPS or endoscopic variceal ligation plus nonselective beta-blockers. The primary outcome is the composite of all-cause death or clinically significant upper gastrointestinal rebleeding within 1 year after randomization.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This multicenter randomized controlled trial is designed to compare an underdilated VCX-TIPS strategy with standard secondary prophylaxis using endoscopic variceal ligation plus nonselective beta-blockers in patients with cirrhosis who have experienced esophageal variceal bleeding or type 1 gastroesophageal variceal bleeding.

Patients with cirrhosis aged 18 to 75 years who have achieved successful control of acute variceal bleeding and are clinically stable will be screened. Eligible participants will be randomized after written informed consent has been obtained, generally between 5 and 21 days after successful hemostasis. Patients with ongoing bleeding, hemodynamic instability, a need for immediate rescue TIPS, or a strong indication for early or pre-emptive TIPS that makes randomization to EVL plus NSBB inappropriate will be excluded.

Participants assigned to the experimental group will undergo TIPS using a commercially available 8-10 mm VIATORR Controlled Expansion stent. After stent deployment, the stent will be initially dilated only with a 6-mm balloon to achieve an initial effective shunt diameter of approximately 6 mm. Further dilation to 8 mm will not be performed solely because the portal pressure gradient remains above 12 mmHg. Additional dilation will be allowed only under predefined rescue conditions, such as persistent active bleeding, inadequate reduction of portal pressure gradient with persistent high-risk collateral perfusion despite embolization, or clinically significant rebleeding during follow-up. Selective embolization of responsible variceal inflow vessels may be performed according to standardized local procedures.

Participants assigned to the control group will receive standard secondary prophylaxis with serial endoscopic variceal ligation and nonselective beta-blockers. Endoscopic variceal ligation will be repeated approximately every 4 weeks until variceal eradication or conversion to a low-risk status. Carvedilol will be the preferred nonselective beta-blocker, starting at 6.25 mg once daily and increasing to 12.5 mg once daily after 1 week if tolerated. Propranolol may be used if carvedilol is not tolerated or is clinically inappropriate.

The primary endpoint is the time from randomization to the first occurrence of all-cause death or clinically significant upper gastrointestinal rebleeding within 365 days. Key secondary outcomes include transplant-free survival, overall survival, liver-related mortality, clinically significant rebleeding, variceal-related rebleeding, overt hepatic encephalopathy, severe overt hepatic encephalopathy, acute-on-chronic liver failure, liver function deterioration, TIPS dysfunction, actual stent diameter at 3 months, unplanned rehospitalization, length of hospital stay, transfusion requirement, direct medical costs, and adverse events. Participants will be followed for 12 months for the primary analysis and up to 24 months for extended secondary outcome analyses.

Tipo di studio

Interventistico

Iscrizione (Stimato)

240

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
      • Chengdu, Cina, 610041
        • West China Hospital, Sichuan University
        • Contatto:
        • Investigatore principale:
          • Xiaoze Wang, MD
      • Chongqing, Cina, 610041
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contatto:
      • Xiamen, Cina, 610041
        • West China Xiamen Hospital, Sichuan University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age 18 to 75 years, regardless of sex.
  • Diagnosis of liver cirrhosis based on previous histology, imaging, laboratory tests, and/or clinical manifestations.
  • Hospitalization for acute upper gastrointestinal bleeding, with endoscopic confirmation that the bleeding is related to esophageal varices or type 1 gastroesophageal varices.
  • Successful control of acute bleeding after standard acute-phase treatment, with stable vital signs and entry into the secondary prophylaxis phase.
  • Child-Pugh score of 5 to 13.
  • The investigator judges that both underdilated VCX-TIPS and EVL plus NSBB are clinically feasible and that randomization is appropriate.
  • The participant or legally authorized representative understands the study procedures and voluntarily signs written informed consent.

Exclusion Criteria:

  • Hemodynamic instability, persistent active bleeding, or need for immediate rescue TIPS, surgical hemostasis, or interventional radiologic hemostasis.
  • A strong current indication for early or pre-emptive TIPS that makes randomization to EVL plus NSBB clinically inappropriate.
  • Child-Pugh score greater than 13.
  • Previous TIPS, surgical portosystemic shunt, BRTO, CARTO, PARTO, or other procedures that substantially alter portosystemic blood flow.
  • Isolated gastric varices, type 2 gastroesophageal varices, ectopic varices, or a bleeding source other than esophageal varices or type 1 gastroesophageal varices.
  • Non-cirrhotic portal hypertension.
  • Cavernous transformation of the portal vein or portal venous thrombosis that makes standardized TIPS technically infeasible.
  • Previous recurrent or refractory overt hepatic encephalopathy, or a history of West Haven grade II to IV overt hepatic encephalopathy unrelated to gastrointestinal bleeding.
  • Severe heart failure, severe pulmonary hypertension, severe tricuspid regurgitation, right heart failure, or other contraindications to TIPS.
  • Uncontrolled severe infection, sepsis, or multiple organ failure.
  • Hepatocellular carcinoma beyond the Milan criteria or other advanced malignancy.
  • Severe renal insufficiency requiring long-term renal replacement therapy.
  • Pregnancy or breastfeeding.
  • Absolute contraindication to EVL, NSBB, or TIPS.
  • Any condition that, in the investigator's judgment, makes the participant unsuitable for the study or unable to complete follow-up.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Underdilated VCX-TIPS
Participants assigned to this group will undergo transjugular intrahepatic portosystemic shunt creation using a commercially available 8-10 mm VIATORR Controlled Expansion stent. After stent deployment, the stent will be initially dilated only with a 6-mm balloon to achieve an initial effective shunt diameter of approximately 6 mm. Further dilation to 8 mm will be allowed only under predefined rescue conditions. Selective embolization of responsible variceal inflow vessels may be performed according to standardized procedures.
Procedura: Underdilated VCX-TIPS
Transjugular intrahepatic portosystemic shunt will be created using a VIATORR Controlled Expansion 8-10 mm stent. The stent will initially be dilated only with a 6-mm balloon. Portal pressure gradient will be measured before and after shunt creation. Additional embolization of responsible variceal inflow vessels may be performed if clinically indicated. Further dilation to 8 mm will be reserved for predefined rescue situations.
Comparatore attivo: EVL Plus NSBB
Participants assigned to this group will receive standard secondary prophylaxis using serial endoscopic variceal ligation combined with nonselective beta-blockers. EVL will be repeated approximately every 4 weeks until variceal eradication or conversion to a low-risk status. Carvedilol will be preferred, with propranolol as an alternative if carvedilol is not tolerated or is clinically inappropriate.
Procedura: Endoscopic Variceal Ligation
Serial endoscopic variceal ligation will be performed according to standardized endoscopic procedures. EVL will be repeated approximately every 4 weeks until variceal eradication or conversion to a low-risk status. For type 1 gastroesophageal varices with substantial gastric extension or high-risk bleeding stigmata, endoscopic tissue adhesive injection may be performed according to local standardized procedures.
Droga: Nonselective Beta-Blockers
Carvedilol will be the preferred nonselective beta-blocker, starting at 6.25 mg once daily and increasing to 12.5 mg once daily after 1 week if tolerated. Dose adjustment, temporary discontinuation, or switching to propranolol will be allowed according to heart rate, blood pressure, renal function, infection status, and overall tolerability.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Composite of All-Cause Death or Clinically Significant Upper Gastrointestinal Rebleeding
Lasso di tempo: From randomization to 1 year
Time from randomization to the first occurrence of all-cause death or clinically significant upper gastrointestinal rebleeding. Clinically significant upper gastrointestinal rebleeding is defined as hematemesis, melena, fresh blood from a nasogastric tube, or endoscopically documented bleeding resulting in hospitalization, blood transfusion, a decrease in hemoglobin of at least 30 g/L, hemodynamic instability, urgent endoscopic, interventional radiologic, or surgical hemostatic therapy, or bleeding-related death. The rebleeding event does not have to be confirmed as variceal in origin for the primary endpoint.
From randomization to 1 year

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Transplant-Free Survival
Lasso di tempo: From randomization to 12 and 24 months
Time from randomization to death from any cause or liver transplantation, whichever occurs first.
From randomization to 12 and 24 months
Liver-Related Mortality
Lasso di tempo: From randomization to 12 and 24 months
Death attributed to liver-related causes, including variceal bleeding, liver failure, acute-on-chronic liver failure, infection related to cirrhosis decompensation, hepatorenal syndrome, or other cirrhosis-related complications.
From randomization to 12 and 24 months
Clinically Significant Upper Gastrointestinal Rebleeding
Lasso di tempo: From randomization to 42 days, 90 days, 180 days, 365 days, and 24 months
Occurrence of clinically significant upper gastrointestinal rebleeding, regardless of whether the bleeding source is confirmed as variceal.
From randomization to 42 days, 90 days, 180 days, 365 days, and 24 months
Variceal-Related Rebleeding
Lasso di tempo: From randomization to 42 days, 90 days, 180 days, 365 days, and 24 months
Upper gastrointestinal rebleeding adjudicated as related to esophageal varices, type 1 gastroesophageal varices, post-EVL ulceration, portal hypertension-related lesions, or TIPS dysfunction.
From randomization to 42 days, 90 days, 180 days, 365 days, and 24 months
Overt Hepatic Encephalopathy
Lasso di tempo: From randomization to 12 and 24 months
Occurrence of overt hepatic encephalopathy, defined as West Haven grade II to IV hepatic encephalopathy.
From randomization to 12 and 24 months
Acute-on-Chronic Liver Failure
Lasso di tempo: From randomization to 12 and 24 months
Occurrence of acute-on-chronic liver failure, defined according to the EASL-CLIF criteria.
From randomization to 12 and 24 months
TIPS Dysfunction
Lasso di tempo: From TIPS placement to 3 months, 12 months, and 24 months
For participants in the TIPS group, TIPS dysfunction is defined as TIPS occlusion, significant stenosis, abnormal TIPS flow velocity associated with clinical recurrence, or the need for balloon dilation, stent revision, TIPS reduction, TIPS occlusion, or parallel TIPS placement.
From TIPS placement to 3 months, 12 months, and 24 months
Actual Stent Diameter at 3 Months
Lasso di tempo: 3 months after TIPS placement
For participants in the TIPS group, actual stent diameter will be assessed by contrast-enhanced CT at 3 months. The imaging core laboratory will measure the minimum and mean diameters of the controlled expansion segment using centerline reconstruction and cross-sectional measurements perpendicular to the stent axis.
3 months after TIPS placement
Adverse Events
Lasso di tempo: From randomization to 24 months
Incidence, severity, relationship to study intervention, management, and outcome of adverse events and serious adverse events.
From randomization to 24 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

West China Hospital

Collaboratori

Southwest Hospital, China
The Second Affiliated Hospital of Chongqing Medical University
The Second Affiliated Hospital of Kunming Medical University
Chengdu Shangjin Nanfu Hospital
West China Tianfu Hospital
Chongqing Qianjiang Central Hospital
West China Xiamen Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

31 marzo 2029

Completamento dello studio (Stimato)

30 luglio 2030

Date di iscrizione allo studio

Primo inviato

7 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2026

Primo Inserito (Effettivo)

14 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • THE002

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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