Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease

Launched by THE CLEVELAND CLINIC · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help people who have advanced liver disease called cirrhosis, combined with severe obesity and a related problem called portal hypertension—this means high blood pressure in the veins of the liver, which can cause serious health risks. The study is testing whether a combination of two treatments—a minimally invasive procedure called TIPS that lowers pressure in the liver, followed by a weight-loss surgery called sleeve gastrectomy—can improve patients’ quality of life and help them lose more weight than standard medical care, which includes diet, lifestyle changes, and medications.

People who might be eligible for this study are adults aged 18 to 70 with a body mass index (BMI) between 35 and 70, diagnosed with cirrhosis and significant portal hypertension but without severe liver failure. Participants will be randomly assigned to either receive the TIPS procedure followed by weight-loss surgery or standard medical weight management. During the study, which lasts at least six months, participants will have regular check-ups to monitor their liver health, weight, and overall well-being. The goal is to find safer, more effective treatments for people facing both obesity and serious liver disease, giving them a better chance at healthier, longer lives. This study is being done at the Cleveland Clinic in Ohio, and all care during the trial will be provided there.

Gender

ALL

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.