Using TIPS Stent Graft to treat complications of cirrhosis and portal hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of the TIPS Stent Graft in patients suffering from portal hypertension due to liver cirrhosis. It is a prospective, multi-center, single-arm study that will follow participants for 12 months after treatment. The primary endpoint is to assess the stent patency at 6 months post-treatment. Eligible patients will be monitored for complications related to variceal bleeding and ascites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The subject who is 18 years old or above but 75 years old or below;
2. The subject who is diagnosed with portal hypertension caused by liver cirrhosis with the history of gastrointestinal variceal bleeding or bleeding, hepatic hydrothorax, and refractory or recurrent ascites;
3. The subject must have adequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of ≤13 or Child-Pugh Score of ≤18;
4. The subject with platelet count≥ 20×10\^9 /L;
5. Subjects or their guardians who can understand the content of the clinical trial, voluntarily participate in the clinical trial and sign the ICF and can complete the follow-up period according to the requirements of the clinical trial.

Exclusion Criteria:

1. The subject who is pregnant or lactating or plan to get pregnant during the clinical trial;
2. According to the judgment of investigator, the subject with main portal vein thrombosis which thrombus occupying \>50% of the portal vein lumen and affecting postoperative hemodynamics;
3. The subject who has received surgical or interventional treatment (such as TIPS, surgical shunt and retrograde transvenous obliteration (-RTO) for treatment of complications from portal hypertension. Note: The subject who have received -RTO for variceal bleeding at least 8 weeks before signing the informed consent form can be included in the clinical trial;
4. The subject who needs to receive or have received splenectomy;
5. The subject who has received or plan to receive liver transplantation;
6. The subject who cannot have a shunt channel established in the liver parenchyma between the hepatic vein and the portal vein as determined by the investigators;
7. The subject with extrahepatic or hepatic malignancies;
8. The subject with Budd-Chiari syndrome and hepatic sinusoidal obstruction syndrome;
9. The subject with congenital cystic dilatation of bile duct (Caroli disease) and obstructive dilation of biliary tract;
10. The subject with polycystic liver disease;
11. The subject with cavernous transformation of the portal vein;
12. The subject with severe or refractory hepatic encephalopathy (Grade 2 or above according to the West Haven Criteria);
13. The subject with a TBIL level higher than 51.3 μmol/L (excluding the Patients with cholestatic cirrhosis);
14. The subject with coagulation disorders (INR: \>2.5);
15. The subject with a systolic pressure lower than 80 mmHg;
16. The subject with severe tricuspid regurgitation or congestive heart failure;
17. The subject with myocardial infarction within the past 3 months;
18. The subject with moderate to severe pulmonary arterial hypertension, or severe hepatopulmonary syndrome;
19. The subject with uncontrolled systemic infection or inflammation;
20. The subject with severe renal insufficiency (Scr level:\>199.5 μmol/L) or needing to receive dialysis;
21. The subject known to be allergic to the contrast media or to the constituent materials of the TIPS covered segment;
22. The subject with the history of epilepsy or mental illness or with cognitive impairment;
23. The subject with the expected survival time of less than 1 year;
24. The subject who is otherwise determined as ineligible for participation in this Study by investigators;
25. The subject who is participating in any other unfinished drug or medical device clinical trials.

Where it's running

• Hunan Provincial People's Hospital
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Huang
• Email: haojia.huang@bd.com
• Phone: 8617801014015

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VIATORR TIPS 6–10 mm: Real-world use in cirrhosis with portal hypertension

  A real-world registry is seeing how the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion 6-10 mm works over 2 years in adults with cirrhosis and portal hypertension.

  Recruiting at 5 sites W.L.Gore & Associates · Atlanta, Georgia and 4 other locations · NCT07390344

• Endovascular treatment outcomes after portal hypertension–related GI bleeding in cirrhosis

  This study tests how well endovascular procedures for portal hypertension–related GI bleeding work in adults with cirrhosis, and what factors predict outcomes.

  Recruiting University Medical Center Ho Chi Minh City (UMC) · Ho Chi Minh City · NCT07918378

• Using Dapagliflozin to help manage ascites in cirrhosis

  This study tests whether adding dapagliflozin to standard care helps people with cirrhosis and ascites reduce fluid buildup and improve outcomes.

  Recruiting Phase 2/3 Beni-Suef University · Giza · NCT07684326

• Factors that affect reopening of blocked portal veins in people with cirrhosis and gastroesophageal varices

  This project looks at past records and follow-up to see which factors are linked with reopening (recanalization) of blocked portal veins in people who have cirrhosis and endoscopy-confirmed gastroesophageal varices.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07473375

• Portal hypertension biobank for esophagogastric varices

  This project will try to collect clinical data, CT images, and biological samples from people with portal hypertension and esophagogastric varices to support multi-omics studies and better-tailored care.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07419724

• Underdilated stent technique to reduce encephalopathy after TIPS

  This trial tries to see if using an underdilated stent (smaller balloon dilation before placing a standard covered stent) during TIPS lowers the chance of hepatic encephalopathy for people with cirrhosis who need TIPS for variceal bleeding or refractory ascites.

  Recruiting at 2 sites The Second Affiliated Hospital of Chongqing Medical University · Chongqing, Chongqing Municipality and 1 other locations · NCT07349654

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.