No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
The Cleveland Clinic · Other
Who this trial is looking for
This trial is looking for patients with severe obesity and cirrhosis with increased pressure in the veins of the liver. Participants will either receive a special procedure to lower liver pressure followed by weight loss surgery or standard weight management care.
Are You a Good Fit for This Trial?
Rules you outSevere pulmonary diseaseSevere psychiatric illnessDecompensated cirrhosis
You may be able to join if
I am between 18 and 70 years old.
I have a body mass index (BMI) between 35 and 70.
I have liver cirrhosis confirmed by a biopsy or assessment.
I have clinically significant portal hypertension.
I can give informed consent and follow study procedures.
I currently have or have used anti-obesity medications.
I am a woman of child-bearing potential and have a negative pregnancy test.
I have insurance coverage for metabolic surgery.
You may not be able to join if
I have had bariatric or metabolic surgery before.
I have had a solid organ transplant.
I have severe lung disease.
I have severe heart disease or recent heart surgery.
I have a history of severe psychiatric illness or substance abuse.
I am pregnant, breastfeeding, or not using contraception.
I have a serious cancer diagnosis in the last year.
I have decompensated cirrhosis.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. Unfortunate…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 insuran…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.