Endoscopic Shunts Embolization for Hepatic Encephalopathy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method for treating stubborn hepatic encephalopathy, a brain condition that occurs when the liver malfunctions. The treatment, called endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts, uses a special ultrasound technique to close off abnormal liver blood flow. The study will compare this new treatment with standard care to determine its safety and effectiveness in improving symptoms. Candidates for this trial include those with liver cirrhosis who have experienced at least two episodes of hepatic encephalopathy despite taking usual medications.
As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance the quality of life for individuals with challenging conditions.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, since participants must have been on medical therapy with lactulose and rifaximin before enrollment, it seems likely that you can continue these medications.
What prior data suggests that endoscopic ultrasound guided embolization is safe for treating refractory hepatic encephalopathy?
Research has shown that endoscopic ultrasound-guided (EUS-guided) embolization is a new treatment under study for safety and effectiveness. In a small study with seven patients, most experienced successful outcomes, with six out of seven cases stopping abnormal blood flow through the shunt. However, some risks exist, including increased pressure in the liver's blood vessels, which might lead to fluid buildup in the abdomen or worsening of swollen veins.
There is also concern that the glue used in the procedure could migrate to other areas, causing complications. Despite these risks, most patients experience manageable side effects. As this is a newer technique, participation in trials like this one helps gather more information on its safety.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for hepatic encephalopathy because they offer new methods for managing spontaneous portosystemic shunts. Unlike traditional surgical procedures, the experimental arm uses endoscopic ultrasound guidance, allowing for a minimally invasive approach through transgastric or transesophageal access. This method utilizes a fine-needle aspiration technique to deliver embolization materials, which could potentially reduce recovery time and improve precision. Meanwhile, the active comparator arm employs interventional radiology techniques to embolize shunts via several access points, offering flexibility in treatment delivery. Both approaches aim to reduce the complications associated with the condition by precisely targeting the shunts, potentially leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for refractory hepatic encephalopathy?
Research has shown that endoscopic ultrasound-guided (EUS) embolization, a treatment under study in this trial, can completely block abnormal blood vessel connections known as spontaneous porto-systemic shunts (SPSS) in patients. In a small study involving 7 patients, this technique successfully closed these shunts. This treatment has shown promise in improving symptoms for individuals with refractory hepatic encephalopathy, a condition where the liver fails to remove toxins from the blood, leading to brain issues. The procedure uses glue and coils to close the shunt and has proven safe and effective in early studies. Although the data comes from a small group, the initial results are encouraging. Another treatment option in this trial is interventional radiology-guided embolization, which also aims to close SPSS using different techniques.12456
Are You a Good Fit for This Trial?
This trial is for adults (18+) with liver cirrhosis who have had at least two episodes of hepatic encephalopathy in the past 6 months, despite standard medications. They must be hospitalized for ongoing symptoms and have a spontaneous portosystemic shunt seen on imaging.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive EUS guided embolization or medical management
Follow-up
Participants receive follow-up EUS procedures one month after embolization for assessment of the shunt patency and development of varices
Extended Follow-up
Participants are monitored for safety and effectiveness, including assessment of hepatic encephalopathy and other complications
What Are the Treatments Tested in This Trial?
Interventions
- Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts
- Interventional Radiology for shunt embolization/retrograde tranvenous obliteration
Trial Overview
The study compares an endoscopic procedure called EUS-guided embolization to block abnormal blood vessels (shunts) versus usual medical treatment, to see if it helps control hard-to-treat hepatic encephalopathy and is safe.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Embolization of the porto-systemic shunt will be performed via endoscopic ultrasound (EUS) transesophageal or transgastric access with a 19G fine-needle aspiration (FNA) EUS needle to embolize the shunt using cyanoacrylate glue and vascular coil injection. The procedure will be performed under general anesthesia, with fluoroscopic guidance and intraprocedural antibiotic prophylaxis.
Embolization of the porto-systemic shunt will be conducted via Trans-Jugular, Trans-Femoral, or direct Trans-hepatic access to embolize the shunt using cyanoacrylate glue, Sodium TetraDecyl Sulfate, Gelfoam, and/or vascular coil injection. The procedure will be performed under deep sedation or general anesthesia, with fluoroscopic guidance and intraprocedural antibiotic prophylaxis.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
Citations
1.
journals.lww.com
journals.lww.com/ajg/fulltext/2023/10001/s2614_endoscopic_ultrasound_guided_transgastric.3117.aspxS2614 Endoscopic Ultrasound Guided Transgastric Shunt...
EUS guided embolization can lead to complete occlusion of SPSS in patients with variceal bleeding. We here describe a series of 7 cases of occlusion of ...
Endoscopic Shunts Embolization for Refractory Hepatic ...
Does EUS guided embolization of large SPSS result in significant clinical improvement in patients with refractory hepatic encephalopathy?
The evolving role of endoscopic ultrasound from diagnosis to ...
The only available evidence for EUS-guided SPSS embolization comes from a first-in-human single-center cohort study involving 7 patients with symptomatic ...
The evolving role of endoscopic ultrasound from diagnosis ...
The only available evidence for EUS-guided SPSS embolization comes from a first-in-human single-center cohort study involving 7 patients with symptomatic ...
Endoscopic Shunts Embolization for Hepatic Encephalopathy
... Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts will have tolerable side effects & efficacy ...
6.
ctv.veeva.com
ctv.veeva.com/study/endoscopic-shunts-embolization-for-refractory-hepatic-encephalopathyEndoscopic Shunts Embolization for Refractory Hepatic ...
The goal of this clinical trial is to learn if endoscopic ultrasound guided (EUS guided) spontaneous porto-systemic shunt (SPSS) ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.