Underdilated-stent Technique Improves Post-transjugular Intrahepatic Portosystemic Shunt Encephalopathy: a Randomized Controlled Trial
Phase: NA
Conditions: Liver Cirrhosis, Variceal Bleeding, Cirrhosis, Ascites Hepatic, Hepatic Encephalopathy (HE)
Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Title page 
 
Effect of underdilated-stent technique on post-transjugular intrahepatic 
portosystemic shunt encephalopathy 
 
NCT Number: NCT ID not yet assigned 
 
Document date: 2024-09-29 
 
 

Study Protocol 
 
1. Research Methods  
(1) Eligibility Criteria 
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. 
Withdrawal Mechanism 
- Patients or their relatives may request study discontinuation during the 
trial.  
(2) Randomization and Intervention 

This study employed computer-generated randomization using sequentially 
numbered envelopes containing treatment protocols. Enrolled participants 
signed written informed consent forms and were randomly assigned to Group 
A or B. Participants remained unaware of their assigned group throughout the 
study. Both groups of patients received identical management protocols 
throughout the perioperative process, including preoperative consultation, 
preparation, monitoring, medication administration, surgical procedures, 
material handling, and postoperative follow-up. The sole difference was the 
use of 8mm (Group A) and 6mm (Group B) balloons for dilation of puncture 
tract and subsequently placed portosystemic stent during TIPS procedures. 
Neither group was administered drugs which might result in pathophysiologic 
affection of hepatic encephalopathy (e.g., lactulose, rifaximin, ornithine 
aspartate, branched-chain amino acids, or arginine) before or after TIPS.  
(3) Sample Size Calculation 
According to literature, the estimated 12-month incidence of overt hepatic 
encephalopathy following 8mm balloon full-dilation and 6mm balloon 
sub-dilation in TIPS patients was 54% and 20%, respectively. With a 
significance level of 5%, power of 80%, and a projected dropout rate of 10%, 
this study required 36 patients per group (two-tailed test).  
(4) Follow-up and Outcomes 
All enrolled patients underwent scheduled follow-up examinations at 1, 3, 6, 
and 12 months after TIPS procedure. The primary outcome was the incidence 

of overt hepatic encephalopathy (West-Haven classification ≥2), while 
secondary outcomes included improvement of portal hypertension 
complications (e.g., esophageal variceal bleeding, worsening ascites), liver 
function, complications, and transplant-free survival.