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Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
NCT07058155 · View on ClinicalTrials.gov ↗
Study Summary
Cirrhosis is a form of advanced liver disease that can lead to serious complications, especially when combined with severe obesity. Many patients with cirrhosis also develop a condition called clinically significant portal hypertension (CSPH), which is increased pressure in the veins of the liver. CSPH raises the risk of life-threatening events like internal bleeding and liver failure. Unfortunately, treatment options for people who have both cirrhosis and severe obesity are very limited, especially when portal hypertension is present. This study, called the OPTIMAL Trial, is a randomized clinical trial designed to evaluate whether combining two procedures improves health outcomes in this high-risk population. The first procedure, called TIPS (Transjugular Intrahepatic Portosystemic Shunt), is a minimally invasive treatment that reduces pressure in the liver by creating a pathway for blood to flow more easily. The second procedure is sleeve gastrectomy, a form of metabolic (bariatric) surgery that helps patients lose weight and improve related conditions like diabetes. The study will compare two groups: 1. One group will receive TIPS followed by sleeve gastrectomy (TIPS+SG). 2. The other group will receive medical weight management (standard non-surgical care, including diet, lifestyle changes, and weight loss medications). All participants will have severe obesity and cirrhosis with CSPH but will not have decompensated liver disease (such as large amounts of fluid in the abdomen, a history of variceal bleeding, or recent liver failure). Eligible participants will be randomly assigned to one of the two groups. The main goal of the study is to determine whether the combination of TIPS + SG improves quality of life and leads to greater weight loss compared to medical therapy alone. The study will also monitor for any complications from either the procedures or the medical treatment. Participants will be followed for 6 months after their treatment starts, with pe
Conditions Studied
Interventions
- PROCEDURE Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- PROCEDURE Sleeve Gastrectomy
- DRUG Anti-Obesity Pharmacotherapy (Class Effect)
- BEHAVIORAL Lifestyle Counseling - Diet & Physical-Activity Program
Study Locations (1)
Ohio
- Cleveland Clinic Main Campus — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2025-12-17 |
| Est. Completion | 2034-02-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07058155
The ClinicalTrials.gov registry entry for NCT07058155 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 607 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Severe Obesity appearing as the primary indexed condition, and to 4 interventions — of which Transjugular Intrahepatic Portosystemic Shunt (TIPS) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07058155 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07058155 about?
NCT07058155 is a clinical study titled "Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease". Cirrhosis is a form of advanced liver disease that can lead to serious complications, especially when combined with severe obesity. Many patients with cirrhosis also develop a condition called clinically significant portal hypertension (CSPH), which is increased pressure in the veins of the liver. C...
What is the current status of trial NCT07058155?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2025-12-17. Estimated completion is 2034-02-01.
What conditions does trial NCT07058155 study?
This clinical trial studies the following conditions: Severe Obesity, Liver Cirrhoses, Portal Hypertension Related to Cirrhosis, TIPS. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07058155?
The interventions under investigation include: Transjugular Intrahepatic Portosystemic Shunt (TIPS) (PROCEDURE), Sleeve Gastrectomy (PROCEDURE), Anti-Obesity Pharmacotherapy (Class Effect) (DRUG), Lifestyle Counseling - Diet & Physical-Activity Program (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07058155?
This trial is sponsored by The Cleveland Clinic, which has 607 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07058155 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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