Liver Cirrhoses study: Sleeve Gastrectomy vs Anti-Obesity Pharmacotherapy
Official title Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
ClinicalTrials.gov ID: NCT07058155
What this study is testing
What is Anti-Obesity Pharmacotherapy (Class Effect)?
This is an investigational group of weight-loss medicines being studied to see if they help people with liver cirrhosis. These medicines are designed to help the body feel full for longer or reduce how much food the brain wants to eat.
Also referred to as GLP-1 receptor agonist, Topiramate, Phentermine, Incretin Mimetics.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if combining a liver procedure with weight-loss surgery improves quality of life and weight loss compared to standard medical care.
- Who it's for
- The study is looking for adults with severe obesity and liver cirrhosis who have high pressure in their liver veins but do not have advanced liver failure.
- What's involved
- Participants will be randomly assigned to either receive a liver shunt procedure followed by sleeve gastrectomy or receive standard medical weight management, including diet and medication.
- Time commitment
- Participants will be followed for 6 months after treatment starts, with some potentially followed longer to check long-term results.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Is a candidate for general anesthesia
- Is ≥18 and ≤70 years old at the time of signing the informed consent
- Has a BMI ≥35 and ≤85 kg/m2 at the time of first study visit
- Is eligible for metabolic surgery (SG) based on the ASMBS/IFSO 2022 guidelines [39]
- Has insurance coverage for metabolic surgery
You likely can't join if
- 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.
- Prior complex foregut surgery including any esophageal and gastric surgeries, anti-reflux procedures, biliary diversion, and complex trauma surgery
- History of solid organ transplant
- Severe pulmonary disease defined as FEV1 \< 50% of predicted value
- Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in...
See the full eligibility criteria
- Is a candidate for general anesthesia
- Is ≥18 and ≤70 years old at the time of signing the informed consent
- Has a BMI ≥35 and ≤85 kg/m2 at the time of first study visit
- Is eligible for metabolic surgery (SG) based on the ASMBS/IFSO 2022 guidelines [39]
- Has insurance coverage for metabolic surgery
- Patients who are currently receiving or have previously received anti-obesity medicines will be considered for participation
- Liver cirrhosis as determined via liver biopsy or noninvasive liver disease assessment
- 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...
- Has the ability and willingness to participate in the study, provide informed consent, and agree to any of the arms involved in the study.
- Has a negative urine pregnancy test at the first visit and at the randomization visits for women of childbearing potential.
- Women of childbearing age must agree to use reliable method of contraception for 2 years.
- 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.
- Prior complex foregut surgery including any esophageal and gastric surgeries, anti-reflux procedures, biliary diversion, and complex trauma surgery
- History of solid organ transplant
- Severe pulmonary disease defined as FEV1 \< 50% of predicted value
- Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)
- Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V
- Left ventricular ejection fraction \<25% at the time of screening
- Myocardial infarction, unstable angina, stroke, heart surgery, coronary stent placement in the past 6 months
- Presence of large hiatal hernia (\>7 cm)
- Presence of erosive esophagitis (LA Grade C and D)
- Presence of active Crohn's disease
- 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...
- Pregnancy, the intention of becoming pregnant, or not using adequate contraceptive measures
- Breastfeeding
- Diagnosis of malignancy within the preceding 1 year, including intra- or extra-hepatic malignancy.
- Clinical judgment that life expectancy is less than 2 years
- Use of investigational therapy within 3 months prior to signing the consent
- Acute pancreatitis \< 90 days before screening
- Portal vein thrombosis
- 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
- Total bilirubin \> 3 mg/dl within 1 month of screening
- INR \> 1.7 within 1 month of screening
- Platelets \<50,000 per microliter within 1 month of screening
- 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...
- 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.
- Known cases of Acquired Immune Deficiency Syndrome (AIDS)
- Unable to understand the risks, benefits, and compliance requirements of study
- Lack capacity to give informed consent
- Plans to move outside the primary location of study (within 3-hour distance of Cleveland) within the next 6 months.
- Previous participation in this trial and got assigned by chance to one of the study groups but did not proceed.
- Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.