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. Is a candidate for general anesthesia 2. Is ≥18 and ≤70 years old at the time of signing the informed consent 3. Has a BMI ≥35 and ≤85 kg/m2 at the time of first study visit 4. Is eligible for metabolic surgery (SG) based on the ASMBS/IFSO 2022 guidelines \[39\] 5. Has insurance coverage for metabolic surgery 6. Patients who are currently receiving or have previously received anti-obesity medicines will be considered for participation 7. Liver cirrhosis as determined via liver biopsy or noninvasive liver disease assessment 8. CSPH as determined by HVPG of ≥ 10-12 mmHg, presence of esophagogastric varices, moderate-to-severe portal hypertensive gastropathy, dilated portal vein (\>13 mm), biphasic or reverse portal vein flow, enlarged paraumbilical veins, splenorenal collaterals, or dilated left and short gastric veins. 9. Has the ability and willingness to participate in the study, provide informed consent, and agree to any of the arms involved in the study. 10. Has a negative urine pregnancy test at the first visit and at the randomization visits for women of childbearing potential. 11. Women of childbearing age must agree to use reliable method of contraception for 2 years. Exclusion Criteria 1. Prior bariatric and metabolic surgery of any kind • Reversed procedures such as gastric band or intragastric balloon that have been removed at least 3 months prior to the first study visit are allowed. 2. Prior complex foregut surgery including any esophageal and gastric surgeries, anti-reflux procedures, biliary diversion, and complex trauma surgery 3. History of solid organ transplant 4. Severe pulmonary disease defined as FEV1 \< 50% of predicted value 5. Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in the next 12 months) 6. Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V 7. Left ventricular ejection fraction \<25% at the time of screening 8. Myocardial infarction, unstable angina, stroke, heart surgery, coronary stent placement in the past 6 months 9. Presence of large hiatal hernia (\>7 cm) 10. Presence of erosive esophagitis (LA Grade C and D) 11. Presence of active Crohn's disease 12. Psychiatric disorders including (but not limited to) dementia, active psychosis, severe depression requiring 3 or more medications, history of suicide attempts, active alcohol, or substance abuse within the previous 12 months that in the opinion of the investigators could disqualify the patient from metabolic surgery 13. Pregnancy, the intention of becoming pregnant, or not using adequate contraceptive measures 14. Breastfeeding 15. Diagnosis of malignancy within the preceding 1 year, including intra- or extra-hepatic malignancy. This includes known hepatocellular carcinoma or evidence of OPTN-V lesion on imaging (except squamous cell and basal cell cancer of the skin). 16. Clinical judgment that life expectancy is less than 2 years 17. Use of investigational therapy within 3 months prior to signing the consent 18. Acute pancreatitis \< 90 days before screening 19. Portal vein thrombosis 20. Decompensated cirrhosis: moderate-to-large volume ascites, hepatic encephalopathy, or patients undergoing liver transplant evaluation. • We will include patients with prior variceal hemorrhage or small volume ascites 21. Total bilirubin \> 3 mg/dl within 1 month of screening 22. INR \> 1.7 within 1 month of screening 23. Platelets \<50,000 per microliter within 1 month of screening 24. Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to the first study visit. • Defined as more than 14 units/week for females (\>1 drink per day) and more than 21 units/week for males (\>2 drinks per day) on average, where one unit of alcohol is equivalent to a 12-ounce beer, 4-ounce glass of wine, or 1-ounce shot of hard liquor. 25. Chronic renal insufficiency with estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73 m2 or being on dialysis within 1 month of screening. 26. Known cases of Acquired Immune Deficiency Syndrome (AIDS) 27. Unable to understand the risks, benefits, and compliance requirements of study 28. Lack capacity to give informed consent 29. Plans to move outside the primary location of study (within 3-hour distance of Cleveland) within the next 6 months. 30. Previous participation in this trial and got randomized to one of the study groups but did not proceed. 31. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study
Contact & Investigator
Ali Aminian, 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 daftarg@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 Ali Aminian, MD at The Cleveland Clinic. The trial plans to enroll 70 participants.