Ascites Hepatic, Hepatic Encephalopathy (HE), Liver Cirrhosis, Variceal Bleeding, Cirrhosis
Conditions
Brief summary
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.
Interventions
DEVICE6mm balloon dilation
A 6mm balloon was used to under-dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure.
DEVICE8mm balloon dilation
A standard 8mm balloon was used to fully dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure.
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
West China Hospital
Qianjiang Hospital, Chongqing University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of overt hepatic encephalopathy | 12 months | West-Haven grade no less than 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| remission of complications of portal hypertention | 12 months | variceal rebleeding diagnosed on endoscopy, or worsened ascites diagnosed by ultrasound or CT/MRI. |
| liver function | 12 months | Child-Pugh Classification |
| liver transplantation-free survival | 12 months | — |
Countries
China
Contacts
CONTACTYongjun Zhu, Doctor
Outcome results
None listed