Actively Recruiting
OPTIMAL Trial: Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Led by The Cleveland Clinic · Updated on 2025-12-23
70
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
A
Ali Aminian, MD
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate a new treatment approach for people with advanced liver disease called cirrhosis, who also have severe obesity and clinically significant portal hypertension (CSPH). These conditions increase the risk of serious complications like internal bleeding and liver failure. The trial, named the OPTIMAL Trial, compares a combination of two procedures with standard medical weight management to see if health outcomes improve in this high-risk group. The study compares two groups of adults aged 18 to 70 with cirrhosis, severe obesity, and CSPH. One group receives a transjugular intrahepatic portosystemic shunt (TIPS) procedure to reduce liver vein pressure, followed by sleeve gastrectomy surgery for weight loss after 4 to 6 weeks. The other group receives medical weight management including diet, exercise counseling, and FDA-approved weight loss medications. Both groups receive standard care and support during the 6-month study period. Participants will attend follow-up visits at 1, 3, and 6 months after treatment starts to monitor weight, vital signs, liver function, and any complications. Liver ultrasound will check the TIPS device in the intervention group. Quality of life is assessed using the SF-36 survey, with the main measure being physical health improvement after 6 months. The study also tracks weight loss percentages, liver-related complications, and metabolic changes. Some participants may be followed longer to understand long-term effects.
CONDITIONS
Brief Title
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Candidate for general anesthesia
- Age 18-70 years at consent
- BMI between 35 and 70 kg/m8
- Eligible for sleeve gastrectomy per ASMBS/IFSO 2022 guidelines
- Insurance coverage for metabolic surgery
- Current or prior anti-obesity medication use allowed
- Liver cirrhosis confirmed by biopsy or non-invasive assessment
- Clinically significant portal hypertension (HVPG 2 10 mm Hg, or esophagogastric varices, or portal vein abnormalities)
- Able and willing to provide informed consent and comply with study procedures
- Women of child-bearing potential must have negative pregnancy test and agree to reliable contraception for 2 years
You will not qualify if you...
- Prior bariatric/metabolic surgery (except removed devices 2 3 months earlier)
- Prior complex foregut surgery
- History of solid-organ transplant
- Severe pulmonary disease (FEV1 < 50% predicted)
- Significant cardiac or atherosclerotic disease with planned re-vascularization within 12 months
- ASA class IV or V uncompensated cardiopulmonary disease
- Left-ventricular ejection fraction < 25% or recent heart attack or surgery
- Hiatal hernia > 7 cm or severe erosive esophagitis
- Active Crohn's disease
- Severe psychiatric illness, dementia, psychosis, recent suicide attempt, or alcohol/substance abuse within 12 months
- Pregnant, breastfeeding, planning pregnancy, or not using adequate contraception
- Malignancy within prior 12 months (except non-melanoma skin cancer)
- Life expectancy < 2 years
- Investigational therapy within 3 months
- Acute pancreatitis within 90 days
- Portal vein thrombosis at screening
- Decompensated cirrhosis (moderate/large ascites, hepatic encephalopathy, or listed for transplant)
- Total bilirubin > 3 mg/dL, INR > 1.7, or platelet count < 50,000/µL
- Significant alcohol intake within past 12 months
- Severe kidney impairment or dialysis
- AIDS
- Unable to understand study or give consent
- Plans to move more than 3 hours from Cleveland within 6 months
- Previous randomization in this trial
- Any condition that places the subject at undue risk as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants in the intervention group first undergo TIPS placement to reduce portal hypertension, followed approximately 4 to 6 weeks later by sleeve gastrectomy surgery once portal pressures stabilize. Participants in the control group receive structured lifestyle counseling and may start anti-obesity medications as part of medical weight management.
Initial procedure visit for TIPS placement, 1 surgery visit for sleeve gastrectomy, plus regular lifestyle counseling sessions
Duration - 6 months
Participants attend follow-up visits at 1, 3, and 6 months after treatment initiation to assess weight, vital signs, liver function, adverse events, and quality of life measures. The intervention group also receives liver Doppler ultrasound to monitor TIPS patency as part of standard care.
3 visits (at 1, 3, and 6 months post-treatment initiation)
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
A
Awwab F Hammad, MD
E
Erlind Allkushi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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