NCT07058155 Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
| NCT ID | NCT07058155 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The Cleveland Clinic |
| Condition | Liver Cirrhoses |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2029-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 70 participants in total. It began in 2025-12-17 with a primary completion date of 2029-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 periodic assessments of their physical health, liver function, and overall well-being. Some participants may also be followed for a longer period to assess long-term outcomes. This study hopes to provide high-quality evidence for a novel, stepwise treatment strategy that may help people with obesity and liver disease live longer, healthier lives. If successful, it could change how advanced liver disease and obesity are managed together, especially in patients who currently have few safe and effective options. All study care is provided at Cleveland Clinic, Cleveland, Ohio, USA.
Eligibility Criteria
Inclusion Criteria 1. Candidate for general anesthesia. 2. Age 18-70 years at consent. 3. BMI 35-70 kg/m² at first study visit. 4. Eligible for sleeve gastrectomy per ASMBS/IFSO 2022 guidelines. 5. Insurance coverage for metabolic surgery. 6. Current or prior anti-obesity medication use permitted. 7. Liver cirrhosis confirmed by biopsy or non-invasive assessment. 8. Clinically significant portal hypertension (HVPG ≥ 10 mm Hg, or esophagogastric varices / portal-hypertensive gastropathy, or imaging evidence of collaterals/dilated portal vein). 9. Able and willing to provide informed consent and comply with study procedures. 10. Women of child-bearing potential: negative urine pregnancy test at screening and randomization and agreement to reliable contraception for 2 years. Exclusion Criteria 1. Prior bariatric/metabolic surgery (except removed devices ≥ 3 months earlier). 2. Prior complex foregut surgery. 3. History of solid-organ transplant. 4. Severe pulmonary disease (FEV1 \< 50 % predicted). 5. Significant cardiac or atherosclerotic disease with planned re-vascularization within 12 months. 6. ASA class IV or V uncompensated cardiopulmonary disease. 7. Left-ventricular ejection fraction \< 25 % or MI/unstable angina/stroke/heart surgery/coronary stent within 6 months. 8. Hiatal hernia \> 7 cm or LA grade C/D erosive esophagitis. 9. Active Crohn's disease. 10. Severe psychiatric illness, dementia, active psychosis, history of suicide attempt, or alcohol/substance abuse within 12 months. 11. Pregnant, breastfeeding, planning pregnancy, or not using adequate contraception. 12. Malignancy within the prior 12 months (except non-melanoma skin cancer). 13. Life expectancy \< 2 years in investigator's judgment. 14. Investigational therapy within 3 months. 15. Acute pancreatitis ≤ 90 days. 16. Portal vein thrombosis at screening. 17. Decompensated cirrhosis (moderate/large ascites, hepatic encephalopathy, or listed for liver transplant); small ascites or prior variceal bleed allowed. 18. Total bilirubin \> 3 mg/dL, INR \> 1.7, or platelets \< 50 000/µL (within 1 month). 19. Significant alcohol intake (\> 14 units/week women, \> 21 units/week men) within the prior 12 months. 20. eGFR \< 45 mL/min/1.73 m² or on dialysis (within 1 month). 21. AIDS. 22. Unable to understand study or give consent. 23. Plans to move more than 3 hours from Cleveland within 6 months. 24. Previous randomization in this trial. 25. Any condition that, in the investigator's opinion, places the subject at undue risk.
Contact & Investigator
Sobia Laique, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT07058155 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Liver Cirrhoses. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07058155 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07058155 currently recruiting?
Yes, NCT07058155 is actively recruiting participants. Contact the research team at hammada4@ccf.org for enrollment information.
Where is the NCT07058155 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07058155 clinical trial?
NCT07058155 is sponsored by The Cleveland Clinic. The principal investigator is Sobia Laique, MD at The Cleveland Clinic. The trial plans to enroll 70 participants.