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

7. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

240

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University
        • Kontakt:
        • Hauptermittler:
          • Xiaoze Wang, MD
      • Chongqing, China, 610041
        • The Second Affiliated Hospital of Chongqing Medical University
        • Kontakt:
      • Xiamen, China, 610041
        • West China Xiamen Hospital, Sichuan University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verfahren: 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.
Aktiver Komparator: 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.
Verfahren: 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.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Composite of All-Cause Death or Clinically Significant Upper Gastrointestinal Rebleeding
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Transplant-Free Survival
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

West China Hospital

Mitarbeiter

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

31. März 2029

Studienabschluss (Geschätzt)

30. Juli 2030

Studienanmeldedaten

Zuerst eingereicht

7. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Mai 2026

Zuerst gepostet (Tatsächlich)

14. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • THE002

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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