Preoperative prediction of overt hepatic encephalopathy caused by transjugular intrahepatic portosystemic shunt.
Yang Yang, Xueqing Liang, Shirui Yang...
https://pubmed.ncbi.nlm.nih.gov/35667296/Actively Recruiting
Led by The Second Affiliated Hospital of Chongqing Medical University · Updated on 2026-01-20
72
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are evaluating the use of an underdilated-stent technique during transjugular intrahepatic portosystemic shunt TIPS procedures to reduce the occurrence of hepatic encephalopathy HE in patients with decompensated liver cirrhosis. HE is a common complication after TIPS, especially within the first 3 to 6 months. Current treatments like lactulose and rifaximin have not been proven to effectively prevent HE after TIPS, and previous studies on underdilated strategies lack high-quality evidence. The study compares two approaches during TIPS one group receives an underdilated strategy using a 6mm balloon to dilate the puncture tract before implanting an 8mm Viatorr stent, which allows the stent to expand gradually over months the other group receives a fully-dilated strategy with an 8mm balloon and an 8mm stent implanted immediately. This randomized controlled trial aims to see if the underdilated method lowers post-TIPS HE without reducing treatment effectiveness for portal hypertension complications. Participants will be monitored for 12 months after the procedure, with researchers assessing the incidence of overt hepatic encephalopathy, remission of portal hypertension complications, liver function, and survival without liver transplantation. The study involves regular evaluations to track these outcomes and ensure patient safety. This long-term follow-up will help determine if the underdilated technique offers benefits in managing complications after TIPS.
CONDITIONS
Underdilated-stent Technique Improves Post-TIPS Encephalopathy
Y
Yongjun Zhu, Doctor
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The Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor
West China Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo the TIPS procedure with either a 6mm or 8mm balloon dilation followed by stent implantation.
1 procedure visit (in-person)
Duration - 12 months
Participants are monitored for complications, liver function, and survival outcomes following the TIPS procedure.
Regular follow-up visits over 12 months
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/25735521/The Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor
West China Hospital
Collaborating Sponsor