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NCT07553858 · ClinicalTrials.gov registry record · NA
Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy
A NA study, sponsored by Rutgers, The State University of New Jersey.
- Not yet
- Registry status
- NA
- Development phase
- 34
- Enrollment target
NCT07553858: Clinical Trial NA study, sponsored by Rutgers, The State University of New Jersey.
NCT07553858 is a NA study that has not yet begun recruiting, run by Rutgers, The State University of New Jersey. The registered enrollment target is 34 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07553858, a NA study, has not yet begun recruiting, sponsored by Rutgers, The State University of New Jersey.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if endoscopic ultrasound guided (EUS guided) spontaneous porto-systemic shunt (SPSS) embolization works to treat refractory hepatic encephalopathy in adults. It will also learn about the safety of EUS guided embolization. The main questions it aims to answer are: 1. Does EUS guided embolization maintain an acceptable safety profile? 2. Does EUS guided embolization of large SPSS result in significant clinical improvement in patients with refractory hepatic encephalopathy? Participants will: 1. Receive EUS guided embolization or medical management. 2. Receive follow-up EUS procedures one month after embolization for assessment of the shunt patency and development of varices (embolization group). 3. Receive follow-up every week for 4 weeks to assess degree of worst episode of hepatic encephalopathy via West Haven criteria.
Primary Outcome
Grade of worst episode of hepatic encephalopathy (HE) during a 4-week period after intervention as measured by West Haven criteria at one week intervals after intervention, (see below for a copy of West Haven Criteria) administered via telephone encounters by study personnel. West Haven Criteria: * Grade 0 (Minimal/Covert): No detectable changes in personality or behavior; minimal deficits in fine motor skills or psychometric tests. * Grade 1 (Covert): Mild lack of awareness, shortened attenti
Interventions
- PROCEDURE Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts
- PROCEDURE Interventional Radiology for shunt embolization/retrograde tranvenous obliteration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2026-05-01 |
| Est. Completion | 2028-11-01 |
| Phase | NA |
What is known before NCT07553858 opens enrollment
NCT07553858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts is the first listed.
NCT07553858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07553858 about?
NCT07553858 is a clinical study titled "Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy". The goal of this clinical trial is to learn if endoscopic ultrasound guided (EUS guided) spontaneous porto-systemic shunt (SPSS) embolization works to treat refractory hepatic encephalopathy in adults. It will also learn about the safety of EUS guided embolization. The main questions it aims to answ...
What is the current status of trial NCT07553858?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 34 participants. The study started on 2026-05-01. Estimated completion is 2028-11-01.
What interventions are being tested in trial NCT07553858?
The interventions under investigation include: Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts (PROCEDURE), Interventional Radiology for shunt embolization/retrograde tranvenous obliteration (PROCEDURE).
Who is sponsoring clinical trial NCT07553858?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07553858's enrollment target sits among peer trials
34 1570th of 2000 higher than 427 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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