Skip to main content
OpenTrials
Completed

NCT Number: NCT02156232

Embolization of Large Spontaneous Portosystemic Shunts for the Prevention of Post-TIPS Hepatic Encephalopathy

The purpose of this study is to determine whether transjugular intrahepatic portosystemic shunt (TIPS) combined with large spontaneous portosystemic shunts embolization are effective in the prevention of hepatic encephalopathy (HE).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

About this study

Transjugular intrahepatic portosystemic shunt (TIPS) has been used for more than 20 years since 1988 to treat some of the complications of portal hypertension, especially variceal bleeding and ascites refractory to conventional therapy. However, this procedure has two major disadvantages: shunt dysfunction and hepatic encephalopathy (HE). Notabley, the use of expanded polytetrafluoroethylene (ePTFE)-covered stent has significantly reduced the risk of shunt dysfunction, but the post-TIPS HE remains a problem even with these new stents.

The incidence of post-TIPS HE ranges between 5% and 35% HE during the first year and tends to be particularly frequent during the first months after TIPS and less common with time. Meta-analysis has that increased age, prior HE and higher Child-Pugh class/score were the most robust predictors for post-TIPS HE.

There is no consensus on the management of post-TIPS HE. Episodic HE after TIPS can be treated traditionally. The cornerstones of the treatment of this type of HE are the identification and treatment of the precipitating event and the general support of the patients. Refractory HE not responding to standard treatment is, in our opinion, the most important problem faced when a patients has to be treated with TIPS. In some cases, the occurrence of this complication may deeply reduce the patient's quality of life and the cure may be worse than the disease. Refractory HE can be treated by reducing the diameter of the stent or by occluding the shunt. However, the procedure is not without dangers and may not solve the problem in all patients, and the complications of portal hypertension, such as varices or refractory ascites, which were supposed to be managed by the TIPS, may recur as a consequence of shunt reduction or occlusion.

Besides, there are no established methods or drugs to effectively prevent the occurrence of HE after TIPS. One possibility is the use of stents with a small diameter, since post-TIPS HE was related to the amount of blood shunted. Riggio et al. compared the incidence of HE after TIPS created with 8-or 10-mm PTFE-covered stents and the study was stopped because of higher complications due to portal hypertension after TIPS in the 8-mm group. Our center performed a RCT to evaluate the effectiveness of L-ornithine-L-aspartate (LOLA) on plasma ammonia in cirrhotic patients after TIPS. Another RCT reevaluateing the effect of TIPS with 8- or 10-mm covered stent for the prevention of variceal rebleeding in cirrhotic patients was also undergoing.

But for those with large spontaneous portosystemic shunts(SPSS), embolization might also represent a therapeutic target.SPSS is, as the name implies, potential communications between the portal venous circulation and the systemic venous circulation that can open, develop, and potentially grow to enable flow within them when one of these circulations (portal or venous) has high pressure or is obstructed or both in an effort to reduce pressure or bypass an obstruction or both. SPSS mainly include splenorenal shunt, gastrorenal shunt, paraesophageal vein, paraumbilical vein, et al. For patients with decompensated cirrhosis, the portal vein pressure increased significantly and some blood were diverted to the systemic circulation by collateral vessels between the splenorenal vein, short gastric veins, posterior gastric vein, and so on, namely SPSS. The nature history of SPSS in patients with liver cirrhosis is still unclear. Most patients were diagnosed by chance.

Previous reports have suggested that the incidence of SPSS was 16% in patients with liver cirrhosis and portal hypertension and the incidence of refractory HE was about 46%. A study published in 2005 revealed that about 71% of the patients with cirrhosis with refractory HE have large SPSS. Therefore, the presence of a SPSS not only provides an explanation for the persistence or recurrence of HE despite an acceptable liver function, it might also represent a therapeutic target. Nowadays, several series have reported embolization of large SPSSs for the treatment of chronic therapy-refractory HE.To date, no data was about the safety and efficacy of embolization of large SPSS in the prevention of post-TIPS HE.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed written informed consent
  • Dignosis of liver cirrhosis (clinical or by liver biopsy)
  • Admission due to variceal bleeding occurred 5 to 42 days prior and standard treatment for secondary prophylaxis failed
  • Confirmed spontaneous portosystemic shunts in abdominal imagings
  • Sum of targeted spontaneous portosystemic shunts diameters greater than half the diameter of portal vein

Exclusion criteria

  • Hepatic carcinoma and/or other malignancy diseases
  • Portal vein thrombosis (≥50% of the lumen)
  • Budd-Chiari syndrome
  • Child-Pugh score>13 points
  • Sepsis
  • Spontaneous bacterial peritonitis
  • Uncontrollable hypertension
  • Serious cardiac or pulmonary dysfunction
  • Renal failure
  • With TIPS contraindications
  • Spontaneous recurrent hepatic encephalopathy
  • Previous TIPS or collateral embolization
  • Pregnancy or breast-feeding
  • History of liver transplantation

Treatment and study plan

TIPS

Procedure

TIPS is performed with a standard technique. TIPS revision will be planned if any evidence of shunt dysfunction is observed.

SPSS embolization

Procedure

Embolization of SPSS will be conducted via the same jugular vein before TIPS implantation. The major procedures included (a) angiography of SPSS after successful intrahepatic puncture of a branch of the portal vein and (b) embolization of SPSS with coils of varying diameters or Amplatzer Vascular Plug, which resulted in the SPSS disappearing at postembolization angiography.

Primary outcomes

  1. Number and severiy of participants with overt hepatic encephalopathy

    Time frame: 2 years

Secondary outcomes

  1. Number of participants with variceal rebleeding

    Time frame: 2 years

  2. Number of participants with shunt dysfunction

    Time frame: 2 years

  3. Change of liver function

    Time frame: 2 years

  4. All-cause mortality

    Time frame: 2 years

  5. Adverse events

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Embolization of Large Spontaneous Portosystemic Shunts for the Prevention of Post-TIPS Hepatic Encephalopathy: a Prospective、Open-labeled、Randomized、Controlled Trial

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2014
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.