Underdilated-Stent Technique for Post-TIPS Encephalopathy Improvement
6mm balloon dilation
+ 8mm balloon dilation
Brain Diseases+12
+ Brain Diseases, Metabolic
+ Central Nervous System Diseases
Prevention Study
Summary
Study start date: November 19, 2024
Actual date on which the first participant was enrolled.Transjugular intrahepatic portosystemic shunt (TIPS) is a vital treatment for managing bleeding in the esophagus and stomach, as well as stubborn fluid build-up in the abdomen due to liver cirrhosis. However, a common complication after this procedure is hepatic encephalopathy (HE), a condition that affects the brain. Currently, no reliable studies have found a drug or intervention that can effectively prevent HE after TIPS, including drugs like lactulose and rifaximin. This study focuses on a new technique called Underdilated Strategy (UDS). UDS uses a smaller balloon to expand the tract and then places a standard-sized covered stent. This allows the stent to maintain a smaller size initially, potentially reducing the risk of HE after the procedure. Over time, the stent gradually expands to its normal size. The study aims to evaluate if UDS can improve post-operative HE without affecting the treatment's effectiveness for portal hypertension complications.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.72 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, ChinaOpen The Second Affiliated Hospital of Chongqing Medical University in Google MapsQianjiang Central Hospital
Qianjiang, China